Name: Key: GA Available Pages H. Directory of e-Learning ... · • Coursera • EdX • FDA •...

Document generated by Confluence on Jun 06, 2014 14:41

Space DetailsKey: GA

Name: A. General Information

Description:

Creator (Creation Date): ecpm (Aug 12, 2009)

Last Modifier (Mod. Date): ecpm (Sep 15, 2010)

Available Pages• H. Directory of e-Learning resources

• videos collected from YouTube• A Guide to Understanding Clinical Trials (video)

• From Molecule to Medicine

• Perspective on the Future of Drug Development Webinar

• PharmacoVigilance - Uppsala Monitoring Centre

• The History of Modern Drug Development (video)

• YouTube - PharmaTrain

• various e-learning providers• AAPS - External eLearning Resources

• alladex.ch• e-Book 1 - Gray's Drug Development

• e-Book 2 - Drug Development Summarised

• e-Course 1 - Alladex Rapid Introductory Drug Development Self-StudyCourse

• e-Course 2 - Drug Development Self-Study Course

• e-Course 3 - Drug Development Outlined

• Bayer Schering Pharma. The Lab Tour ? From molecules to medicine

• Commlab India - Training Solutions for Pharmaceuticals, Bio-Tech & HealthCare Industries

• Coursera

• EdX

• FDA• FDA 101. Product Recalls (video)

• IFPMA• IFPMA Clinical Trials Portal

• IFPMA - Inside Innovation. The Drug Discovery Process

• Johnson & Johnson and Medialink. From Molecule to Medicine

• Know How AG - Stuttgart

• MedLine Plus• Allergies to Dust Mites - Medline Plus

• Asthma - Medline Plus

• Brain Cancer - Medline Plus

• Diabetes - Introduction

• Drug Abuse - Medline Plus

• Drug Interactions


• Drug Safety - Medline Plus

• H1N1 Flu or Swine Flu

• Interactive Health Tutorials - Medline Plus

• International Health - Medline Plus

• Parkinson's Disease - Medline Plus

• Smoking - The Facts

• Tinnitus - Medline Plus

• Understanding Clinical Trials

• Understanding Medical Words

• MRC, Medical Research Council• Consent for tissue - collecting, storing and using human tissue

• Good clinical practice for non-clinical trialists

• Human Tissue Act - training for investigators

• Research and human tissue legislation

• National Health Service, UK• Clinical trials and medical research

• NHS Education for Scotland (NES), eLearning Resources

• pharmaSquare• pharmaSquare Courses

• PharmExec.com - Pharmaceutical Executive Podcasts

• Postgraduate Coursework - Drug Development - UNSW

• SeerPharma - e-Learning

• SouthWest Training Institute - Free Preview Resources

• Synergix Ltd - Drug Design - drugdesign.com

• TEDDY NoE e-Learning Platform• CHILDREN ARE NOT LITTLE ADULTS

• CLINICAL TRIALS INVOLVING CHILDREN - Methodological aspects

• THE EUROPEAN PAEDIATRIC REGULATION

• The Design Studio (Discovery of the potential new medicines)

• The Henry Stewart Talks

• The School of Pharmacy - University of London• e-Learning and e-Teaching Demonstration Material

• Thomson Reuter IDRAC Regulatory online learning

• UC Television - Health and Medicine• Pharmacy 102. Breakthrough Medicines

• Zenosis

• miscellaneous resources• animations

• Drug discovery and development process, Novartis

• article-based e-learning• In vitro PLOTs in pharmaceutical development

• conversation about drug pricing

• economics of healthcare


• PRINCIPLES OF HEALTH ECONOMICS for non-economists

• ethics and legal issues• Research Ethics Training Curriculum

• health economics• The Economics of Health Care - oheschools.org

• OnlineGCP

• Pharmaceutical Research and Development. A Description and Analysis ofthe Process, 2001

• pharmacokinetics• A First Course in Pharmacokinetics and Biopharmaceutics, OUHSC

College of Pharmacy• boomer_org

• Pharmacokinetics and Biopharmaceutics, Univ. of Iowa

• Pharmacokinetics - Pharmaceutics - Biopharmaceutics

• Rx Kinetics

• pharmacology• Basics of pharmacology, Univ. of Vienna

• Recommendations on Clinical Research - JAPhMed

• SMi Source

• statistics• creascience_com

• davidmlane_com

• Online Statistics - An Interactive Multimedia Course of Study

• statistics_com

• StatSoft Electronic Statistics Textbook

• translational medicine• Biomedical informatics and translational medicine

• Translational Medicine - doing it backwards

• video-based e-learning• LabTube - Drug Research


H. Directory of e-Learning resources

This page last changed on Apr 19, 2013 by nhaider.

About this DirectoryThis is a collection of metadata describing various e-learning resources (multimediamaterials, recorded lessons, e-books, interactive tools, animations, or just singledocuments) related to the field of medicines research and development. Resources fromwithin the PharmaTrain consortium have found their way into the PharmaTrain e-libraryand are available there. Various other resources which might also be of some interest forteaching purposes are listed in this directory here. Please note that PharmaTrain is notresponsible for the content of these resources and cannot guarantee for their quality.

PDF snapshot of the resource directoryFor a PDF snapshot of the resource directory, click here.

http://collab.pharmatrain.eu/download/attachments/2654243/PharmaTrain_e-Directory_Version_Apr2013.jpg

http://collab.pharmatrain.eu/download/attachments/2654243/eLearning_Resource_Directory_Apr2013.pdf?version=2


videos collected from YouTube

This page last changed on Mar 10, 2010 by nhaider.

videos collected from YouTube


A Guide to Understanding Clinical Trials (video)

This page last changed on Aug 11, 2010 by nhaider.

Resource Details and Annotation

Resource Title A Guide to Understanding Clinical Trials(video)

URL http://www.youtube.com/watch?v=eSQFL5OXGGM&feature=related

Short Description ClinicalConnection 18. Dezember 2008A Guide to Understanding Clinical Trials broughtto you by http://www.ClinicalConnection.com.To find clinical trials listings please visit http://www.ClinicalConnection.comTags:

• clinical trials• medical research• clinical research• drug trials• human research• drug research• investigators• research• medicine• drug development• fda• clinical trial• clinical studies• medical research studies• medical trials

Context stand_alone

Module/Course/Related Document(if resource is part of a collection)

Syllabus Context 7. Clinical Trials

e-Learning Provider (organization) other

e-Learning Provider (other) ClinicalConnection

Country other

Country (other) USA

Language English

Language (other)

Resource Type multimedia_document

Resource Type (other)

SCORM Package available unknown

Copyright/Licence Type free

http://www.youtube.com/watch?v=eSQFL5OXGGM&feature=related

http://www.youtube.com/watch?v=eSQFL5OXGGM&feature=related

http://www.ClinicalConnection.com




Copyright/Licence (details)

Delivery Mode web_based

Delivery Mode (other)

Technical Requirements common_web_browser JavaScript Flash_Player

Technical Requirements (other)

Server-side Technology (CMS/LMS type, etc.) YouTube

Interactivity Level no_interactivity_static_document

Registration is_not_necessary

Registration (details)

Author(s)

Detailed Structure(Table of Contents)

Guide to understanding clinical trials1. What are clinical trials?2. Why are clinical trials important?3. Why should I be interested?4. What can I expect?5. Who is eligible for clinical trials?6. What protection do you have?7. Where can I get more information?8. How can I find clinical trials that I am eligiblefor?Original Link:http://www.clinicalconnection.com

Time Consumption(Estimated Duration)

about 4 min

Evaluation Comments:.Technology Related

Web-based free video.

Evaluation Comments:.Content / Didactics Related

Record created by Pavel Dallakian, Norbert Haider

Record created by (other)

Date (yyyy-mm-dd) 2010-08-11, Last update 2010-08-11

Contact (Directory of e-Learning Resources): Norbert Haider

Comments

The video is for a naive public. Probably too basic for the PharmaTrain audience.

Posted by jpkraehenbuhl at May 29, 2011......................................................................................................................................................................

http://www.clinicalconnection.com

http://collab.pharmatrain.eu/display/~nhaider


From Molecule to Medicine



Resource Title From Molecule to Medicine

URL http://www.youtube.com/watch?v=mI5uhDEr56A

Short Description Explaining the Drug Discovery Process from ThePharmaceutical Research and Manufacturersof America (PhRMA). http://www.phrma.org/about_phrma

Context stand_alone


Syllabus Context 2. Development of Medicines: Planning


e-Learning Provider (other) PhRMA

Country other

Country (other) USA

Language English

Language (other)

Resource Type multimedia_documentaudio_includedvideo_included







Technical Requirements common_web_browserJavaScriptFlash_Player



Interactivity Level moderate_interactivity_document_with_interactive_elements


http://www.youtube.com/watch?v=mI5uhDEr56A

http://www.phrma.org/about_phrma

http://www.phrma.org/about_phrma



Author(s) PhRMA


Video Material


~6min


Flash Video



Date (yyyy-mm-dd) 2010-03-10


Comments

This vieo is on the home page of CLIC. Excellent as an introduction to Drug development.




Perspective on the Future of Drug Development Webinar

This page last changed on May 30, 2011 by nhaider.


Resource Title Perspective on the Future of DrugDevelopment Webinar

URL http://www.youtube.com/watch?v=oDM7VXTNTsk

Short Description Webinar: Perspective on the future of drugdevelopment, October 16th 2008 The Tessellaand Pharmaceutical Business Review free webinarPerspective on the future of drug development,broadcast on October 16th 2008, was a hugesuccess with over 140 listeners worldwide.Speakers included Tessella's Tom Parke and GrantStephen, Prof Don Berry of Berry Consultants,and Nick Bennett the lead pharma analyst atDatamonitor.

Context stand_alone


Syllabus Context 1. Discovery of Medicines2. Development of Medicines: Planning


e-Learning Provider (other) Yahoo Video

Country other

Country (other) USA

Language English

Language (other)

Resource Type multimedia_document audio_included









Server-side Technology (CMS/LMS type, etc.)

http://www.youtube.com/watch?v=oDM7VXTNTsk





Author(s)


Webinar:Perspective on the future of drug development,October 16th 2008Presenters: Prof. Donald Berry - Senior StatisticalScientist, Berry ConsultansTom Parke - Head of Clinical Trials Solutions,TessellaPanel member: Grant Stephen - CEO, Tessella Inc.Moderator: Nick Bennett - Healthcare Researchand Analysis Direktor, Datamonitor


65 min







Comments

I was not able to see the webinar. The link opens a video: Driving with your mind


The link has been updated:


Posted by nhaider at May 30, 2011......................................................................................................................................................................




PharmacoVigilance - Uppsala Monitoring Centre



Resource Title PharmacoVigilance - Uppsala MonitoringCentre

URL http://www.youtube.com/watch?v=SUF_Gmukhvc

Short Description From Uppsala Monitoring Centre as the globalleader in pharmacovigilance.

Context stand_alone


Syllabus Context 11. Drug Safety, Pharmacovigilance andPharmacoepidemiology

e-Learning Provider(organization) other

e-Learning Provider (other) Uppsala Monitoring Centre

Country other

Country (other) Sweden

Language English

Language (other)










Server-side Technology(CMS/LMS type, etc.) YouTube



http://www.youtube.com/watch?v=SUF_Gmukhvc



Author(s) Uppsala Monitoring Centre


Video Material


~5min


Flash Video





Comments

A good introduction to pharmacovigilance. A bit long for the description of an agency.




The History of Modern Drug Development (video)



Resource Title The History of Modern Drug Development(video)

URL http://www.youtube.com/watch?v=cqxqotelP9c&feature=related

Short Description This video attempts to cover the (early) modernhistory of the drug development.

Context stand_alone


Syllabus Context


e-Learning Provider (other) YouTube

Country other

Country (other) USA

Language English

Language (other)














Author(s)

http://www.youtube.com/watch?v=cqxqotelP9c&feature=related

http://www.youtube.com/watch?v=cqxqotelP9c&feature=related



1. Historical progression to drug development2. Paul Ehrlich (1854-1915)2.1 Plasmodia and trypanosomes2.2 Methylene blue


about 7min


Web-based free video.




Date (yyyy-mm-dd) 2010-08-11, Last update: 2010-08-11


Comments

Provides interesting information but the format is not adequate. Could be summarized in a much shorteranimation.




YouTube - PharmaTrain



Resource Title YouTube - PharmaTrain

URL http://www.youtube.com/watch?v=Z1Y68vtfi6o

Short Description PHARMATRAIN: Pharmaceutical Medicine TrainingProgrammes Fritz Buhler, University of BaselCategory: Science & Technology

Context part_of_collection


Syllabus Context


e-Learning Provider (other) Yahoo Video

Country Switzerland

Country (other)

Language English

Language (other)












Registration is_required


Author(s)

Detailed Structure

http://www.youtube.com/watch?v=Z1Y68vtfi6o


(Table of Contents) PHARMATRAIN: Pharmaceutical Medicine TrainingProgrammes Fritz Buhler, University of BaselCategory: Science & TechnologyTags:IMIInnovative Medicine InitiativeEfpiaStakeholder Forum 2010Michel GoldmanRoch DoliveuxPhilipps CupersBruno FlamionNicola BedlingtonStavros MalasTitta Rosvall-PuplettMagali PoinotChristian NoeDG ResearchRTDEMAEuropean Medicine AgencyEuropean Patients' ForumStates representatives GroupScientific CommitteeFundation IMIMNovartisUniversity of MarseilleLundbeckAstraZenicaLa RocheF-Hoffman - La Roche



Web-based video




Date (yyyy-mm-dd) 2011-05-12;Last update 2011-05-12




various e-learning providers

This page last changed on Sep 06, 2012 by nhaider.

This page lists resources from e-learning providers who are not (or not directly) involved in the creationof the PharmaTrain e-library. Therefore, no resources from Hibernia, HSeT, UBIL-3, or eCLIN are listedhere.


AAPS - External eLearning Resources



Resource Title AAPS - External eLearning Resources - Fee-based Resources and Free Resources

URL http://mediaserver.aapspharmaceutica.com/meetings/exres/exres.htm

Short Description AAPS neither endorses, warrants, supports norreceives compensation from external resourceslisted on this page. Use of external content isentirely at your own risk. Descriptions below mayhave been written by the provider. All trademarksare the property of their respective owners.

Context stand_alone


Syllabus Context


e-Learning Provider (other) AAPS

Country other

Country (other) USA

Language English

Language (other)




Copyright/Licence Type not_free




Technical Requirements common_web_browser JavaScript Flash_PlayerJava





http://mediaserver.aapspharmaceutica.com/meetings/exres/exres.htm

http://mediaserver.aapspharmaceutica.com/meetings/exres/exres.htm



Author(s)


Fee-based ResourcesMolecular Conceptor 2™ - The MedicinalChemistry & Drug Design Coursewarehttp://www.molecular-conceptor.comThis educational courseware presents theprinciples of medicinal chemistry, rational drugdesign, molecular modeling and cheminformaticsusing 3D technology, practical examples and casestudies. The course is updated regularly and itcontains over 6000 slides, and more than 1500 3-D molecules.LearnWrighthttp://www.learnwright.comLearnWright is a training-focused technologyleader that creates and delivers web-based,multimedia e-learning courses to pharmaceuticaland biotech drug and medical device companiesoperating globally in FDA-regulated industriesfollowing Good Manufacturing Practice (GMP)and Quality System Regulations (QSR). Wealso offer a state of the art, hosted LearningManagement System (LMS), capabilities tomanage our courseware. Our portfolio of award-winning training courseware, combined with ourConsulting Services, is a total training solution.KRM Information Services Virtual Podiumhttp://www.krm.com/vpThis highly regarded firm offers an ongoing seriesof live webinars on management, teambuilding,time management and other professionaldevelopment topics.Free ResourcesImproving Your Writing Skillshttp://leo.stcloudstate.edu/index.htmlFrom St. Cloud State University, an excellentseries of tutorials on all aspects of writing;especially useful to scientists for whom English isnot their native language.Tutorials on the Use of Microsoft Products &Technologyhttp://www.microsoft.com/Education/Tutorials.mspxEspecially designed for academia, these tutorialsfrom Microsoft cover the use of all products fromAccess to Word.Merge Your PDF Fileshttp://www.mergepdf.netA free Web-based service that allows you tocreate one pdf file from many. Quick and easy!



The collection of the external e-Learningresources: fee-based and free.


http://www.molecular-conceptor.com

http://www.learnwright.com

http://www.krm.com/vp

http://leo.stcloudstate.edu/index.html

http://www.microsoft.com/Education/Tutorials.mspx

http://www.microsoft.com/Education/Tutorials.mspx

http://www.mergepdf.net


alladex.ch

This page last changed on Dec 09, 2009 by nhaider.


e-Book 1 - Gray's Drug Development

This page last changed on Jun 06, 2014 by nhaider.


Resource Title e-Book 1: Gray's Drug Development

URL http://www.alladex.ch/course/?menu=books

Short Description The book explains the process of developinga drug from laboratory to market in a clear,comprehensive way, covering all aspects in a260-page text linked to an approximately 1900-page guideline appendix, with self-assessmentquestions and answers (see General Descriptionand Table of Contents below for more details)Sample from e-Book is available: http://www.alladex.ch/course/example/samplesbookmar10.pdf



Alladex: Drug Development Rapid Learning Tools



e-Learning Provider (other) NC Neuroconsulting GmbH (alladex.ch)

Country Switzerland

Country (other)

Language English

Language (other)

Resource Type simple_document




Copyright/Licence (details) Pricing is dependent on number of participants- please apply to [email protected] or call01141798215770



Technical Requirements common_web_browserJavaScriptAdobe_Reader


http://www.alladex.ch/course/?menu=books

http://www.alladex.ch/course/example/samplesbookmar10.pdf







Registration (details) NC Neuroconsulting GmbHLoerracherstrasse 504125 Riehen / SwitzerlandTelefon : +41 41 763 57 57E-Mail : [email protected] / SwitzerlandCourse Director and responsible for the content:Dr. Julian Gray

Author(s) Julian Gray


Table of ContentsLIST OF ABBREVIATIONS 15FOREWORD 17HOW TO USE THE E-BOOK 191. OUTLINE OF THE DEVELOPMENT PROCESS 241.1 INTRODUCTION/ALLADEX ROADMAP 24Figure 1: Alladex Roadmap ALLADEX ROADMAP251.2 MINI-OUTLINE OF THE DEVELOPMENTPROCESS 26Basic Laboratory Research - Screening and LeadOptimisation 26Safety Studies in Animals - Non-clinical Testing 26Studies in Humans ? Clinical Trials 26Parallel Activities during Human Studies 27Pre-Marketing Regulatory Submissions 271.3 DURATION OF THE DRUG DEVELOPMENTPROCESS 27Time pressure 281.4 PROBABILITY OF SUCCESS 281.5 APPROXIMATE EXTERNAL COSTS 29SELF-ASSESSMENT QUESTIONS 312. DEVELOPMENT PLANNING 322.1 PROJECT PLANNING 322.2 THE TARGET PROFILE 332.3 SCENARIO PLANNING 34Figure 3: Examples of Development Scenarios 36SELF-ASSESSMENT QUESTIONS 373. THE PROJECT TEAM 383.1 TEAM MEMBERSHIP 38Figure 4: Typical Project Team 38Project Leader 39Project Manager 39Clinical expert 39Clinical Scientist 39Clinical operations expert 39Medical Writer 40Clinical Pharmacologist 40Pharmacologist / Biologist 40Toxicologist 40Regulatory expert 40Manufacturing expert 40Business Expert 403.2 FUNCTIONING AND MOTIVATION OF THETEAM 413.2.1 Goals 41


3.2.2 Team Meetings 413.2.3 Cross-functional Interaction 413.2.4 Communication 413.2.5 Motivation and Success 42SELF-ASSESSMENT QUESTIONS 434. PROJECT MANAGEMENT 444.1 INTRODUCTION 44Figure 5: Matrix Organisation 454.2 PLANNING TOOLS 45Figure 6: 45Figure 7: 46Figure 8: 47SELF-ASSESSMENT QUESTIONS 485. DRUG DISCOVERY 495.1 TARGET SELECTION 495.2 SCREENING 515.2.1 Finding hits 515.2.2 Finding and optimising ?leads? 525.2.3 Selecting a Candidate 535.2.4 Screening for biologics 535.2.5 In vivo animal Models 545.2.6 PK/PD Modelling 54SELF-ASSESSMENT QUESTIONS 566. BASIC MANUFACTURING ISSUES 576.1 INTRODUCTION 576.2 GOOD MANUFACTURING PRACTICE 58Drug Master File 586.3 DRUG SUBSTANCE 586.3.1 Introduction 586.3.2 Scaling Up ? and Related Issues 596.3.3 Salts and Racemates 606.3.4 By-Products and Impurities 606.3.5 Sterility 616.3.6 Standard Operating Procedures/Documentation 616.3.7 Validation 616.3.8 Stability 616.4 DRUG PRODUCT 626.4.1 Drug Packaging 636.4.2 Scale-up of Drug Product Manufacture /Bioequivalence testing 636.4.3 Planning for clinical trial supplies 656.4.4 Packaging and Labelling 656.4.5 Stability testing for clinical studies 666.5 BIOLOGICS 66SELF-ASSESSMENT QUESTIONS 687. NON-CLINICAL SAFETY 697.1 INTRODUCTION 697.2 SAFETY MARGINS/ NOAEL/ TOXICOKINETICS707.3 GENOTOXICITY STUDIES 701) Ames Test 702) The Chromosome Aberration Test. 71In vivo testing 717.4 ADME /PROTEIN BINDING STUDIES 71Protein Binding 727.5 SAFETY PHARMACOLOGY 727.6 ACUTE, SUBACUTE AND CHRONICTOXICOLOGY STUDIES 737.7 REPRODUCTIVE TOXICITY STUDIES 74Segment I: Fertility and general reproductiveperformance 75Segment II: Embryotoxicity/Teratogenicity 75Segment III: Peri/postnatal Toxicity 75


7.8 CARCINOGENICITY STUDIES 767.9 OTHER STUDIES ? IMMUNOTOXICITY, LOCALTOLERANCE 777.10 STUDIES IN JUVENILE ANIMALS 777.11 TOXICITY TESTING FOR BIOTECHNOLOGYDERIVED COMPOUNDS 77SELF-ASSESSMENT QUESTIONS 798. INTRODUCTION TO PHARMACOKINETICS 818.1 ASSAY DEVELOPMENT 818.2 BASIC PHARMACOKINETICS 81Figure 10: 82Figure 11: Alladex Profile after Multiple Dosing 848.3 ADME/Microdosing 868.4 POPULATION PHARMACOKINETICS 868.5 DRUG-DRUG INTERACTIONS 87PGP 908.6 OTHER INTERACTION STUDIES ? FOOD,GENDER, AGE 918.7 STUDIES IN SPECIAL POPULATIONS ? RENALAND HEPATIC IMPAIRMENT 91SELF-ASSESSMENT QUESTIONS 949. REGULATORY ISSUES (GUIDELINES/IND/IMPD/JAPAN/MEETINGS) 969.1 INTRODUCTION / KEY WEBSITES 969.2 COMMENCING TRIALS IN THE US ? THE IND -INVESTIGATIONAL NEW DRUG APPLICATION 979.2.1 Exploratory Ind 1049.2.2 Other Meetings With Fda 1049.2.3 Clinical Trial Registration 1049.3 COMMENCING TRIALS IN EUROPE ? THECLINICAL TRIAL APPLICATION 1049.4 REGULATORY PROCEDURES IN JAPAN 105SELF-ASSESSMENT QUESTIONS 10710. INTRODUCTION TO CLINICAL RESEARCHAND GOOD CLINICAL PRACTICE: HOW CLINICALSTUDIES ARE CONDUCTED 10810.1 INTRODUCTION 10810.2 AN OVERVIEW OF HOW A CLINICAL STUDYWORKS 108Figure 13: Key Activities to Start a Clinical Study11110.3 STUDY PROTOCOLS AND SYNOPSES 11210.4 STUDY OBJECTIVES AND ENDPOINTS 11610.5 STUDY DESIGN 11710.6 STUDY DURATION 11810.7 INCLUSION/EXCLUSION CRITERIA 11910.8 STUDY PROCEDURES 11910.9 STUDY DRUG 12010.10 THE IRB/ETHICS COMMITTEE 12110.11 INFORMED CONSENT 12210.12 INVESTIGATOR?S BROCHURE 122Title Page 123Confidentiality Statement 123Contents of the Investigator?s Brochure 123Table of Contents 123Summary 124Introduction 124Physical, Chemical, and Pharmaceutical Propertiesand Formulation 124Nonclinical Studies 124Introduction: 124(a) Nonclinical Pharmacology 125(b) Pharmacokinetics and Product Metabolism inAnimals 125


(c) Toxicology 125Effects in Humans 126Introduction: 126(a) Pharmacokinetics and Product Metabolism inHumans 126(b) Safety and Efficacy 126(c) Marketing Experience 127Summary of Data and Guidance for theInvestigator 12710.13 SITE SELECTION/CONTRACTS 12710.14 CENTRAL LABORATORIES 12810.15 STUDY MONITORING 128The critical role of the study monitor 12810.16 STANDARD OPERATING PROCEDURES(SOPS) 12910.17 WORKING WITH A CRO ? AN ESSENTIALSKILL 13710.18 AUDITING 13710.19 INVESTIGATOR MEETING 13710.20 TRANSLATION AND LANGUAGES 13810.21 PROTOCOL AMENDMENTS 13810.22 SCIENCE VS. PRACTICALITY 13910.23 TRIAL COMMITTEES 13910.24 CLINICAL STUDY REPORTS 13910.25 PUBLICATION 14210.26 PEDIATRIC STUDIES 142SELF-ASSESSMENT QUESTIONS 14411. STATISTICS AND DATA MANAGEMENT 14511.1 STATISTICS 14511.1.1 Introduction 14511.1.2 Randomisation 14511.1.3 Control Groups 14511.1.4 "P" V alues 14611.1.5 Measures of Variability 14611.1.6 Sample Size Estimation 14711.1.7 Non-Inferiority or Equivalence Studies;active comparators 14811.1.8 Stratification 14811.1.9 Statistical Analysis Plan / Populations /missing data 14911.1.10 Statistical tests 14911.1.11 Treatment by Center Interaction 15111.1.12 Interim Analysis / sequential analysis /adaptive design 15111.2 DATA MANAGEMENT 15311.2.1 The database 15311.2.2 Case Report forms 15311.2.3 Data entry 15411.2.4 Data queries 15511.2.5 Electronic data capture 15511.2.6 CDISC 15511.2.7 Conclusion 155SELF-ASSESSMENT QUESTIONS 15712. DRUG SAFETY 15912.1 INTRODUCTION 15912.2 ADVERSE EVENTS 15912.2.1 Relationship to Study Medication 15912.2.2 Recording adverse events 16112.2.3 Assessment of severity 16112.2.4 Discontinuation due to AEs 16212.2.5 Follow-up of adverse events andassessment of outcome 16212.3 SERIOUS ADVERSE EVENTS 16212.3.1 Definition 162


12.3.2 Reporting serious adverse events 16312.3.3 Causality assessment of serious adverseevents 16412.3.4 Follow-up of serious adverse events 16412.3.5 Reporting to Authorities/SUSARs 16412.4 CODING OF ADVERSE EVENTS 16612.5 ASSESSING INCIDENCE OF AES 16612.6 COMMON SAFETY ISSUES 16712.6.1 Liver Enzymes 16712.6.2 The ECG 16812.6.3 Vital Signs 17012.7 DATA SAFETY MONITORING BOARD 17012.8 PERIODIC SAFETY UPDATE REPORTS 171SELF-ASSESSMENT QUESTIONS 17213. PHASE I STUDIES 17313.1 INTRODUCTION 17313.2 ENTRY INTO MAN 17313.2.1 Non-Clinical Data Needed for Going intoMan 17313.2.2 Clinical Entry into Man Studies 17413.3 MULTIPLE ASCENDING DOSE STUDIES 17513.4 FOOD, GENDER AND OTHER SPECIAL PHASEI STUDIES 17613.5 BIOMARKERS AND PK/PD MODELLING 17613.6 PHARMACOGENETICS 17713.6.1 Pharmacogenetics 17713.6.2 Pharmacogenomics / SNIPS 177SELF-ASSESSMENT QUESTIONS 17914. PHASE IIA STUDIES 18014.1 INTRODUCTION 18114.2 ENDPOINTS 18114.2.1 Biomarkers 18214.3 STUDY DESIGNS 18214.4 LEARNING AND CONFIRMING; EXPOSURE-RESPONSE DATA AND PK/PD MODEL- BASEDDEVELOPMENT 18314.4.1 Exposure response data 18314.4.2 PK/PD Modeling 18414.4.3 End of Phase IIA meeting 184SELF-ASSESSMENT QUESTIONS 18615. PHASE IIB STUDIES 18715.1.1 Dose-finding ? a critically important step18815.1.2 clinical trial simulation 18915.1.3 adaptive clinical trial design 189SELF-ASSESSMENT QUESTIONS 19116. PHASE III STUDIES 19216.1 TWO PIVOTAL TRIALS ? AND EXCEPTIONS19316.1.1 The single pivotal study 19316.2 PATIENT NUMBERS 19416.3 PITFALLS OF MULTICENTER TRIALS 19416.4 RATER TRAINING 195SELF-ASSESSMENT QUESTIONS 19617. PHARMACOECONOMICS 19717.1 INTRODUCTION 197Methodology 197Cost minimisation analysis 197Cost-consequence analysis 197Cost benefit analysis 197Cost effectiveness analysis 197Cost Utility Analysis 19817.2 BURDEN OF ILLNESS STUDIES 19817.3 NUMBER NEEDED TO TREAT 198


17.4 COLLECTING INFORMATION FROM TRIALSDURING DEVELOPMENT 199SELF-ASSESSMENT QUESTIONS 20118. REGULATORY ISSUES (MAA/NDA FILINGS)20218.1 THE COMMON TECHNICAL DOCUMENT 20218.2 DRUG NAMES 20518.3 SUMMARY OF PRODUCT CHARACTERISTICS206SUMMARY OF PRODUCT CHARACTERISTICS(EXAMPLE) 20618.4 REGIONAL DIFFERENCES 21118.4.1 Specific steps in the US 211Freedom of Information 21218.4.2 Specific Steps in the EU 212Submission Routes 212Specific steps in the EU 21318.5 FAST TRACK/ACCELERATED APPROVAL/CONDITIONAL APPROVAL 21318.6 RISK MANAGEMENT PLAN 21418.7 ORPHAN DRUGS 214SELF-ASSESSMENT QUESTIONS 21619. PATENTS 21819.1 INTRODUCTION 21819.2 REQUIREMENTS FOR A PATENT 21819.3 PATENT APPLICATIONS 21919.4 TYPES OF CLAIM 21919.5 DURATION OF PATENT PROTECTION 21919.6 MANAGING PATENT EXPIRY 22019.7 DATA EXCLUSIVITY 221SELF-ASSESSMENT QUESTIONS 22220. PROJECT VALUATION 22320.1 INTRODUCTION 22320.2 CALCULATING THE NPV 22320.3 ESTIMATION OF RISK 226SELF-ASSESSMENT QUESTIONS 22921. A PERFECT CASE 23021.1 INTRODUCTION 23021.2 THE CASE 230ANSWERS TO SELF-ASSESSMENT QUESTIONS234INDEX 254APPENDICES Pages 255 - 2152APPENDIX 1ICH GuidelinesAPPENDIX 2Code of Federal Regulations (Excerpts)APPENDIX 3EU Directive/ Directive 2001/20/EC of theEuropean Parliamentand of the Council of 4 April 2001APPENDIX 4:Declaration of HelsinkiAPPENDIX 5:Common Toxicity CriteriaAPPENDIX 6:Drug Development and Drug InteractionsTable of Substrates, Inhibitors and InducersAPPENDIX 7:Common Technical Document (CTD ? EU version)APPENDIX 8List of FDA GuidelinesAPPENDIX 9:


List of European Medicines Agency (EMEA)Guidelines




This superb account of the subject succeeds inextracting the essentials while being of sufficientdepth to make it suitable for a range of readersfrom science and business backgrounds, frombeginners to those with prior knowledge in onearea. The linkage to regulatory guidelines is ofparticular value, making this a unique learningtool. The clarity of the text reflects the teachingstyle of Dr Gray on the European Course ofPharmaceutical Medicine which has been highlyvalued over many years.Professor Fritz Buhler, MD, Professor ofPharmaceutical Medicine and Pathophysiology,University of Basel, former Head of WorldwideClinical R&D at Roche, Basel, Switzerland(taken from http://www.alladex.ch/course/?menu=clients)




http://www.alladex.ch/course/?menu=clients

http://www.alladex.ch/course/?menu=clients



e-Book 2 - Drug Development Summarised



Resource Title e-Book 2: Drug Development Summarised

URL http://www.alladex.ch/course/?menu=books

Short Description The book is a concise summary of all key aspectsof the subject in a 48-page text with self-assessment questions and answers (see GeneralDescription and Table of Contents below).







Country Switzerland

Country (other)

Language English

Language (other)













http://www.alladex.ch/course/?menu=books





LIST OF ABBREVIATIONS 41. A Helicopter View of Drug Development 52. Development Planning and ProjectManagement: Target Profile, Patents, Time, Cost,Risk, Parallel Activities 103. Screening/Preclinical Development 134. Regulatory Issues 155. Preclinical Safety 176. Manufacturing 197. Clinical Research and Development: ClinicalStudies;Data Management; Statistics; Drug Safety 217.1 Clinical Studies 217.2 Data Management 237.3 Statistics and Basic Study Design 247.4 Drug Safety 268. Phase I and Pharmacokinetics 298.1 Phase I studies 298.2 Pharmacokinetics 309. Phase II 349.1 Phase IIA 349.2 Phase IIB Dose Finding 3410. Phase III/Health Economics 3610.1 Phase III studies 3610.2 Pharmacoeconomics 3611. Filing for Approval 3812. Teamwork 40QUICK QUIZ 41ANSWERS TO QUIZ 43INDEX 47




Sample from the e-Book is available:http://www.alladex.ch/course/example/sampledrugdevsummarized22.pdf




http://www.alladex.ch/course/example/sampledrugdevsummarized22.pdf

http://www.alladex.ch/course/example/sampledrugdevsummarized22.pdf



e-Course 1 - Alladex Rapid Introductory Drug Development Self-Study Course



Resource Title e-Course 1: Alladex Rapid Introductory DrugDevelopment Self-Study Course

URL http://www.alladex.com/

Short Description This concentrated but effective introduction todrug development consists of a two or threestep approach: First the short e-Book DrugDevelopment Summarised is studied includinganswering of the quiz (estimated study time 1.5 -2 hours); second the narrated presentation DrugDevelopment Outlined is watched (estimatedtime 1.5 hours); optionally, for groups, a live webseminar is held with the author, who presentsthe seminar Milestones and Millstones in DrugDevelopment, recapping materials already learnedand answering questions as needed.







Country Switzerland

Country (other)

Language English

Language (other)

Resource Type multimedia_documentaudio_includedvideo_includedself_assessment







http://www.alladex.com/


Technical Requirements common_web_browserJavaScriptAdobe_ReaderFlash_Player









Answering of the quiz (estimated study time 1.5 -2 hours); second the narrated presentation DrugDevelopment Outlined is watched (estimatedtime 1.5 hours); optionally, for groups, a live webseminar is held with the author.








e-Course 2 - Drug Development Self-Study Course



Resource Title e-Course 2: Drug Development Self-StudyCourse

URL http://www.alladex.ch/course/?menu=ecourses

Short Description A 6-Part self-study introductory course on drugdevelopment incorporating materials from theAlladex e-Tools, which are provided free to thosepurchasing the course, as well as examples fromthe unique Alladex case study







Country Switzerland

Country (other)

Language English

Language (other)











http://www.alladex.ch/course/?menu=ecourses







Course Syllabus

• Overview: Phases, time, cost; developmentplanning; the project team

• Preclinical: discovery, pharmacogenomics,proteomics, screening, candidate selection,safety margin/toxicokinetics, safetypharmacology, carcinogenicity

• Safety: Genotoxicity, single and repeated-dose toxicity studies, safety margins, ADMEstudies, CYP profiling

• Manufacturing: drug substance - stability,analytics, impurities, drug product, analytics,bioequivalence, drug supplies

• Clinical Pharmacology: assays, basicpharmacokinetic concepts, singleand multiple dose studies, specialstudies, modeling, population PK/PD,pharmacogenetics

• Statistics and data management: basicconcepts, p values, confidence intervals,normal and non-normally distributed data,sample size estimation, interim analysis,basics of data management

• Clinical Research Principles: GCP - E6;the study protocol, informed consent,investigator brochure, clinical study report;insurance; investigator meetings/training;monitoring, auditing

• Clinical Trial Phases: Phase I studies:starting dose selection, single and multipledose studies, special studies inluding drug-drug interaction studies; Phase II A - proofof concept, biomarkers vs clinical endpoint;learning/confirming/PK/PD modeling; PhaseIIB - dose finding studies; adaptive design;Phase III studies, pivotal studies, numbersrequired for safety

• Drug Safety: AEs, SAEs, SUSARs, theElectrocardiogram, liver function tests,DSMBs

• Regulatory: regulatory bodies, Guidelines,CTA/IMPD, Advice meetings, Orphan DrugRegulations, MAA/NDA submission, CommonTechnical Document

• Pharmacoeconomics: Cost-minimisationanalysis; Cost-consequence analysis; Cost-benefit analysis Cost-effectiveness analysis;


Cost-utility analysis, QALYs, burden of illnessstudies, NNT

• Patents: applications, claims, duration,extensions

• Development Planning: classical vsalternative scenarios; project management

• Teamwork: general and global teamwork,motivation




Sample Content Self-Study Course is available:http://www.alladex.ch/course/example/Samplecontentselfstudycourse.pdf




http://www.alladex.ch/course/example/Samplecontentselfstudycourse.pdf

http://www.alladex.ch/course/example/Samplecontentselfstudycourse.pdf



e-Course 3 - Drug Development Outlined



Resource Title e-Course 3: Drug Development Outlined

URL http://www.alladex.ch/course/?menu=ecourses

Short Description This one-hour narrated presentation introducesthe steps and key points involved in bringinga new drug from the laboratory to the market,followed by a self-assessment quiz.






e-Learning Provider (other) Alladex: Drug Development Rapid Learning Tools

Country Switzerland

Country (other)

Language English

Language (other)

Resource Type multimedia_documentaudio_includedself_assessment










http://www.alladex.ch/course/?menu=ecourses







Table of content:From the Lab to the Market: Overview, Time,Cost, Risks (Slide 4-6)Project Team, Target Profile, DevelopmentPlanning (Slide 7 - 10)Regulatory Bodies, Guidelines, Meetings (Slide 11- 12)Manufacturing (Slide 13 -16)Discovery/Screening (Slide 17)Non-Clinical Safety (Slide 18-20)Designing Clinical Studies (Slide 21-22)Running Clinical Studies (Slide 23-28)Data management (Slide 29)Statistics (Slide 30-31)Drug Safety (Slide 32)The Electrocardiogram (Slide 32)Recommended Numbers of Patients for Safety(Slide 34)Phase I Studies (Slide 35)Pharmacokinetics (Slide 36-39)Pharmacogenetics (Slide 40)Phase IIA Studies (Slide 41-42)Phase IIB Studies (Slide 43)Phase III Studies (Slide 44)Recap 1 (Slide 45)Parallel Activities (Slide 46)Pharmacoeconomics (Slide 47)Regulatory filing (Slide 48-50)Orphan Drug Regulation (Slide 51)Special Approval Procedures (Slide 52)Benefit/Risk Ratio (Slide 53)Recap 2 (Slide 54)Quiz


One-hour narrated presentation


Demo presentation (needs Flash Player ) isavailable: http://www.alladex.ch/ecourse_sample/player.html




http://www.alladex.ch/ecourse_sample/player.html

http://www.alladex.ch/ecourse_sample/player.html


Bayer Schering Pharma. The Lab Tour ? From molecules to medicine



Resource Title Bayer Schering Pharma. The Lab Tour ? Frommolecules to medicine

URL http://www.bayerpharma.com/en/research_and_development/the_labtour/index.php

Short Description The development of medicines takesapproximately 12 years. During this time,highly qualified scientists work on finding theappropriate active substance in a large amountof candidates. They explore between 5,000 and10,000 substances, the larger part of whichalready fail in the laboratory. Only one of thefour candidates that reach the clinical trial phaseultimately achieves regulatory approval.The lab tour offers you a journey through theworld of research at Bayer Schering Pharma. Takea tour from "Target Discovery" to "Approval". Youhave the option to join a tour guide on her waythrough research and development in a 20-minutefilm which introduces the day-to-day business.For your information - the film consists of elevenchapters which can also be selected separately.Another option would be to go on a virtual tourthrough research.

Context stand_alone




e-Learning Provider (other) Bayer Schering Pharma

Country other

Country (other) Germany

Language English

Language (other)

Resource Type multimedia_document audio_includedvideo_included




http://www.bayerpharma.com/en/research_and_development/the_labtour/index.php













Author(s)


The Lab Tour ? From molecules to medicineVideo Contents:IntroChapter 1. Finding the right approach: TargetDiscoveryChapter 2. Looking for the needle in the haystack:High-Throughput Screening (HTS) TechnologyChapter 3. Modelling molecules: StructuralBiology/Computational ChemistryChapter 4. Finding the optimum: MedicinalChemistryChapter 5. Understanding the effects:Pharmacology and ToxicologyChapter 6. Packaging the active ingredients:GalenicsChapter 7. Testing tolerability: Phase I of clinicaldevelopmentChapter 8. Conforming efficacy: Phases II and IIIof clinical developmentChapter 9. Predicting individual effects:PharmacogenomicsChapter 10. Putting it all together: RegulatoryaffairsChapter 11. Drug approval: Inspection throughthe respective authorities



Flash Video "The Lab Tour - From molecules tomedicine"






Commlab India - Training Solutions for Pharmaceuticals, Bio-Tech & HealthCare Industries

This page last changed on Oct 18, 2010 by nhaider.


Resource Title Training Solutions for Pharmaceuticals, Bio-Tech & Health Care Industries

URL http://www.commlabindia.com/elearning-presentation/

Short Description With over nine years' experience in e-learning,CommLab India has worked with top-notchpharmaceutical and healthcare companiesworldwide, we have developed courseware andcontent solutions specific to their business needs.We are committed to improving the skills of thepeople of these industries and addressing criticalissues such as:

• Laboratory Safety Management• Standard Operating Procedure• Pharma Regulatory and Compliance• Pharma Sales Training• Clinical Trials• Drug Development Process• Medical Devices and Equipment

Context stand_alone


Syllabus Context


e-Learning Provider (other) CommLab India

Country other

Country (other) India

Language English

Language (other)



SCORM Package available yes





http://www.commlabindia.com/elearning-presentation/

http://www.commlabindia.com/elearning-presentation/


Technical Requirements common_web_browser JavaScript Adobe_ReaderFlash_Player






Author(s)


Free Trial

• Laboratory Safety Management• Standard Operating Procedure• Pharma Regulatory and Compliance• Pharma Sales Training• Clinical Trials• Drug Development Process• Medical Devices and Equipment



Web-based HTML presentation. Downloadable asPDF document.




Date (yyyy-mm-dd) 2010-10-18, Last Update: 2010-10-18




Coursera



Resource Title Coursera

URL https://www.coursera.org/

Short Description Coursera is an education company that partnerswith the top universities and organizations inthe world to offer courses online for anyone totake, for free. They offer courses in a wide rangeof topics, spanning the Humanities, Medicine,Biology, Social Sciences, Mathematics, Business,Computer Science, and many others.

Context stand_alone


Syllabus Context


e-Learning Provider (other)

Country other

Country (other) USA

Language English

Language (other)








Technical Requirements common_web_browser



Interactivity Level



https://www.coursera.org/


Author(s)


Example: detailed structure of "Drug discovery,development & commercialisation":Week 1:- Pharmaceutical & Biotechnology IndustryLandscape, Williams Ettouati, Pharm. D.- Drug Discovery & Development Process: LifeCycle Strategic Plan, Williams Ettouati, Pharm.D.Week 2:- Drug Discovery: Proteomics, Genomics, PhilipBourne, Ph.D.- Compound Selection & Preclinical Studies,Ronald Christopher, Ph.D.Week 3:- Challenges in Fragment Based Drug Discoveryfor Protein Kinases, Stephen Burley, M.D., Ph.D.- Key Concepts in Drug Delivery, Brookie Best,Pharm.D.Week 4:- Regulatory Considerations When Filing anInvestigational New Drug Application, Susan Trieu,Pharm.D.- Clinical Study & Start-up activities, Joseph Ma,Pharm.D.Week 5:- Clinical Trials: Phase 1, Yazdi Pithavala, Ph.D.- Phase II Clinical Trials, Kourosh Parivar,M.Pharm.Week 6:- Industry Considerations with Phase III ClinicalTrials, Katie Lyons, Pharm.D.- New Drug Application, Filing, Product Labeling,Kelly Hogan, Pharm.D.Week 7:- Pharmacoeconomics in Drug Development, JanHirsch, Ph.D.- Intellectual Property Strategy & BioSimilars,Williams Ettouati, Pharm.D.Week 8:- Marketing Pharmaceuticals & BiotechnologyDrugs, Williams Ettouati, Pharm.D.- Managed Markets and Sales Strategy, DoralFredericks, Pharm.D., MBAWeek 9:- Academic Industry partnership "Various models,Various outcomes", Remi Brouard, M.D.- From Start up to Success in Biotech, BarryQuart, Pharm.D.Optional Lecture- Drug Discovery: Targets & Tools JamesChristensen, Ph.D.----Other courses relevant to medicines research anddevelopment:* Vaccines* Nanotechnology and nanosensors* Case-based introduction to biostatistics




A collection of various e-Learning resources;freely available


Record created by Norbert Haider, Jean-Marie Boeynaems






EdX



Resource Title EdX

URL https://www.edx.org/

Short Description EdX is a not-for-profit enterprise of its foundingpartners, the Massachusetts Institute ofTechnology (MIT) and Harvard University thatoffers online learning to on-campus studentsand to millions of people around the world. Todo so, edX is building an open-source onlinelearning platform and hosts an online web portalat www.edx.org for online education.

Context stand_alone


Syllabus Context



Country other

Country (other) USA

Language English

Language (other)











Interactivity Level


https://www.edx.org/

http://www.edx.org



Author(s)


EdX currently offers HarvardX, MITx andBerkeleyX classes online for free. Beginning in fall2013, edX will offer WellesleyX, GeorgetownX andthe University of Texas System classes online forfree. The UT System includes nine universitiesand six health institutions. In 2014, edX willfurther expand its consortium, including severalinternational schools, when it begins offeringcourses from École Polytechnique Fédérale deLausanne, McGill University, University of Toronto,Australian National University, Delft Universityof Technology, and Rice University. The subjectscovered are changing all the time but some maybe of interest to persons in drug developmentThere are 9 current courses, which mightloosely be of interest to persons involved indrug development: Introduction to Biology- The secret of life (basics of #biochemistry,genetics, molecular biology, recombinant DNA,genomics and rational medicine); Introductionto Statistics: Descriptive Statistics ; Introductionto solid state chemistry and Introduction toComputer Science and programming (for thoseinvolved in programming tools used for computer-modelling) ; Health in Numbers: QuantitativeMethods in Clinical & Public Health Research(adapted material from the Harvard Schoolof Public Health's classes in epidemiology andbiostatistics )Course update (Aug 2013):Fundamentals of clinical trials; Take your medicine- the impact of drug development;Genomicmedicine gets personal; Introduction to bioethics



A collection of external e-Learning resources;freely available


Record created by Norbert Haider, info provided by Donna Ellender






FDA


FDA, U.S. Food and Drug Administration - http://www.fda.gov/default.htm

http://www.fda.gov/default.htm


FDA 101. Product Recalls (video)



Resource Title FDA 101: Product Recalls (video)

URL http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm182929.htm

Short Description FDA, U.S. Food and Drug AdministrationWhen an FDA-regulated product is defectiveor potentially harmful, removing it from themarket may be necessary. In this ConsumerUpdate video, FDA Recall Operations Team LeaderArmando Zamora, explains how FDA managesproduct recalls.



FDA

Syllabus Context 11. Drug Safety, Pharmacovigilance andPharmacoepidemiology


e-Learning Provider (other) FDA

Country other

Country (other) USA

Language English

Language (other)












http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm182929.htm

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm182929.htm




Author(s)


FDA First Alert1. Company contacts FDA2. FDA finds problem during inspection3. FDA receives report4. CDC (Centers for disease control andprevention) contacts FDA5. FDA seeks publicity about a recall when itbelieves the public needs to be alerted to aserious hazard.6. The agency oversees a company's recallstrategy and determines when the recall iscomplete.



Web-based multimedia (Flash) presentation.




Date (yyyy-mm-dd) 2010-05-03 13:02:41




IFPMA


The International Federation of Pharmaceutical Manufacturers & Associations is the global non-profit NGOrepresenting the research-based pharmaceutical, biotech and vaccine sectors. Its members comprise 25leading international companies and 44 national and regional industry associations covering developedand developing countries.


IFPMA Clinical Trials Portal



Resource Title IFPMA Clinical Trials Portal

URL http://clinicaltrials.ifpma.org/clinicaltrials/en/myportal/videotour/index.htm

Short Description Video TourWith a revamped search engine, new functionsand personalised myPortal accounts, the IFPMAClinical Trials Portal is more powerful than ever.Learn how to make the most of these features bywatching the short video below. It will save youtime and improve your search results!

Context stand_alone




e-Learning Provider (other) IFPMA

Country other

Country (other) USA

Language English

Language (other)













http://clinicaltrials.ifpma.org/clinicaltrials/en/myportal/videotour/index.htm

http://clinicaltrials.ifpma.org/clinicaltrials/en/myportal/videotour/index.htm



Author(s)




Web Portal.




Date (yyyy-mm-dd) 2010-08-11 13:15:51




IFPMA - Inside Innovation. The Drug Discovery Process

This page last changed on Feb 17, 2011 by nhaider.


Resource Title Inside Innovation: The Drug DiscoveryProcess

URL http://clinicaltrials.ifpma.org/clinicaltrials/en/tips/drug-development/index.htm

Short Description The path from understanding a disease to treatingit is long, difficult and expensive, but it is themission of pharmaceutical research companies toface these challenges. For the first time in history,scientists are beginning to understand the innerworkings of human diseases at the molecularlevel.This interactive module, brought to you byinnovation.org, explores the R&D process in aunique way. Interact with the video clips below toexplore a single stage of the R&D process or clickon the "Start Video" button to watch the processfrom beginning to end.

Context stand_alone




e-Learning Provider (other) IFPMA

Country other

Country (other) UK

Language English

Language (other)








Technical Requirements

http://clinicaltrials.ifpma.org/clinicaltrials/en/tips/drug-development/index.htm

http://clinicaltrials.ifpma.org/clinicaltrials/en/tips/drug-development/index.htm


common_web_browser JavaScript Flash_PlayerJava



Interactivity Level high_interactivity_simulation_software_etc



Author(s)


Drug DiscoveryFinding a promising molecule (a "lead compound")that could become a drugArmed with their understanding of the disease,scientists are ready to begin looking for a drug.They search for a molecule, or "lead compound,"that may act on their target to alter the diseasecourse. If successful over long odds and years oftesting, the lead compound can ultimately becomea new medicine.There are a few ways to find a lead compound:Nature: Until recently, scientists usually turnedto nature to find interesting compounds forfighting disease. Bacteria found in soil and moldyplants both led to important new treatments,for example. Nature still offers many usefulsubstances, but now there are other ways toapproach drug discovery.De novo: Thanks to advances in chemistry,scientists can also create molecules from scratch.They can use sophisticated computer modeling topredict what type of molecule may work.High-throughput Screening: This process is themost common way that leads are usually found.Advances in robotics and computational powerallow researchers to test hundreds of thousands ofcompounds against the target to identify any thatmight be promising. Based on the results, severallead compounds are usually selected for furtherstudy.Biotechnology: Scientists can also geneticallyengineer living systems to produce disease-fighting biological molecules.The Drug Discovery stage also includes:

• Early Safety Tests: Performing initial tests onpromising compounds

• Lead Optimization: Altering the structure oflead candidates to improve properties



Clinical Trials Portal.Flash Video "Inside Innovation: The DrugDiscovery Process"

Evaluation Comments:.


Content / Didactics Related







Johnson & Johnson and Medialink. From Molecule to Medicine



Resource Title Johnson & Johnson and Medialink: FromMolecule to Medicine

URL http://www.jnj.com/connect/news/all/20080515_122000

Short Description New York (May 15, 2008) - Pharmaceuticalresearch and development (R&D) is a complexendeavor. It often takes up to 14 years and abillion dollars of investment to turn a moleculeinto a medicine that saves patients lives. And,the journey from discovery to market, is filledwith challenges. For every 10 compounds thatshow promise, just one new drug makes it to themarket. "From Molecule to Medicine," is an award-winning movie created by Johnson & JohnsonPharmaceutical Research & Development, L.L.C.,that takes the viewer on an exciting behind-the-scenes journey through the pharmaceutical R&Dprocess.(See video from Johnson & Johnson (NYSE:JNJ) at: http://jnj.mediaseed.tv/Story.aspx?story=35096)

Context stand_alone




e-Learning Provider (other) Johnson & Johnson

Country other

Country (other) USA

Language English

Language (other)







http://www.jnj.com/connect/news/all/20080515_122000

http://www.jnj.com/connect/news/all/20080515_122000

http://jnj.mediaseed.tv/Story.aspx?story=35096

http://jnj.mediaseed.tv/Story.aspx?story=35096









Author(s)


An award-winning movie created by Johnson &Johnson Pharmaceutical Research & Development,L.L.C., that takes the viewer on an excitingbehind-the-scenes journey through thepharmaceutical R&D process.



Flash Video "From Molecule to Medicine"








Know How AG - Stuttgart

This page last changed on Nov 03, 2010 by nhaider.


Resource Title Know How! AG - Stuttgart, Germany

URL http://www.knowhow-elearning.de/referenzen_chemie_pharma.html

Short Description http://en.knowhow.de/companySince 1992 Know How! AG, based in StuttgartGermany, has operated as an independentcompany, under the directorship of its owners,and has continuously developed innovativeeducation concepts and training solutions. Thecompanies Know How IT-Solutions GmbH andSeemedia GmbH are our subsidiaries.As a pioneer working in the field of Web BasedTraining (WBT), we released our first successful E-learning products in 1995.Both in the IT field and the non-IT field we offerappropriate concepts and solutions for customersfrom all industries.High quality E-learning, practice-orientated in-class seminars and requirements-orientatedconsulting are among our core competences.Based in Germany, our customers appreciate ourprofessional services for the German market aswell as for their international subsidiaries.With Know How! our goal is to support theprofessional development of your employeesto the required knowledge level in a targetedmanner.

Context stand_alone


Syllabus Context


e-Learning Provider (other) Know How AG - Stuttgart

Country other

Country (other) Germany

Language English

Language (other) German





http://www.knowhow-elearning.de/referenzen_chemie_pharma.html

http://www.knowhow-elearning.de/referenzen_chemie_pharma.html

http://en.knowhow.de/company










Registration (details) Know How!Aktiengesellschaft für WeiterbildungRuppmannstr. 33b70565 StuttgartTelephone: +49 (0) 711 780 59-0Telefax: +49 (0) 711 780 59-15E-mail: [email protected]: Martin Kundt, Frieder TempelChairman of the supervisory board: ThiloRentschler

Author(s)


Standard WBTMigration WizardSkill Level TestTandem LearningLMS



Web portal of the Company (E-Learning provider).








MedLine Plus


MedLine Plus - http://www.nlm.nih.gov/medlineplus/medlineplus.html

http://www.nlm.nih.gov/medlineplus/medlineplus.html


Allergies to Dust Mites - Medline Plus

This page last changed on Jun 14, 2010 by nhaider.


Resource Title Allergies to Dust Mites - Medline Plus

URL http://www.nlm.nih.gov/medlineplus/tutorials/allergiestodustmites/htm/index.htm

Short Description Dust Mite Allergy: of the many components inhouse dust to which people may be allergic, themost important is the house dust mite. Housedust mites are microscopic, insect-like creaturesrelated to the tick and spider family. They feedprimarily on scales from human skin and arefound in most areas commonly inhabited bypeople. This patient education tutorial is aninteractive health education resource from thePatient Education Institute. Using animatedgraphics this tutorial explains a procedure orcondition in easy-to-read language. You can alsolisten to the tutorial.



Medline Plus

Syllabus Context 14. Therapeutics


e-Learning Provider (other) Medline Plus

Country other

Country (other) USA

Language English

Language (other)










http://www.nlm.nih.gov/medlineplus/tutorials/allergiestodustmites/htm/index.htm

http://www.nlm.nih.gov/medlineplus/tutorials/allergiestodustmites/htm/index.htm






Author(s)


Dust Mite Allergy1. Introduction2. Allergies3. Allergies to House Dust Mites4. Recommended steps to control House DustMites5. Medication6. Summary



Web-based multimedia (Flash, PDF) presentation.




Date (yyyy-mm-dd) 2010-06-14; last update 2010-06-14




Asthma - Medline Plus



Resource Title Asthma - Medline Plus

URL http://www.nlm.nih.gov/medlineplus/tutorials/asthma/htm/index.htm

Short Description Asthma is a common disease of the lungs,affecting millions of people. This patient educationtutorial is an interactive health educationresource from the Patient Education Institute.Using animated graphics this tutorial explains aprocedure or condition in easy-to-read language.You can also listen to the tutorial.



Medline Plus




Country other

Country (other) USA

Language English

Language (other)

Resource Type multimedia_documentaudio_included










http://www.nlm.nih.gov/medlineplus/tutorials/asthma/htm/index.htm

http://www.nlm.nih.gov/medlineplus/tutorials/asthma/htm/index.htm





Author(s)


Asthma1. Introduction2. Anatomy3. Symptoms and their causes4. Triggers5. Diagnosis6. Treatment options5. Summaryhttp://collab.pharmatrain.eu/download/attachments/10878990/asthma.pdf







Date (yyyy-mm-dd) 2010-05-26, last update 2010-05-26


http://collab.pharmatrain.eu/download/attachments/10878990/asthma.pdf

http://collab.pharmatrain.eu/download/attachments/10878990/asthma.pdf



Brain Cancer - Medline Plus



Resource Title Brain Cancer - Medline Plus

URL http://www.nlm.nih.gov/medlineplus/tutorials/braincancer/htm/index.htm

Short Description Brain cancer is not rare. About 20,000 Americansare diagnosed with brain cancer of related cancerof the nervous system. This patient educationtutorial is an interactive health educationresource from the Patient Education Institute.Using animated graphics this tutorial explains aprocedure or condition in easy-to-read language.You can also listen to the tutorial.See also:Breast Cancer, http://www.nlm.nih.gov/medlineplus/tutorials/breastcancer/htm/Colon Cancer, http://www.nlm.nih.gov/medlineplus/tutorials/coloncancer/htm/Lung Cancer, http://www.nlm.nih.gov/medlineplus/tutorials/lungcancer/htm/Ovarian Cancer, http://www.nlm.nih.gov/medlineplus/tutorials/ovariancancer/htm/What's Prostate Cancer, http://www.nlm.nih.gov/medlineplus/tutorials/whatisprostatecancer/htm/Skin Cancer Non-Melanoma, http://www.nlm.nih.gov/medlineplus/tutorials/skincancerandmelanoma/htm/



Medline Plus




Country other

Country (other) USA

Language English

Language (other)





http://www.nlm.nih.gov/medlineplus/tutorials/braincancer/htm/index.htm

http://www.nlm.nih.gov/medlineplus/tutorials/braincancer/htm/index.htm

http://www.nlm.nih.gov/medlineplus/tutorials/breastcancer/htm/

http://www.nlm.nih.gov/medlineplus/tutorials/breastcancer/htm/

http://www.nlm.nih.gov/medlineplus/tutorials/coloncancer/htm/

http://www.nlm.nih.gov/medlineplus/tutorials/coloncancer/htm/

http://www.nlm.nih.gov/medlineplus/tutorials/lungcancer/htm/

http://www.nlm.nih.gov/medlineplus/tutorials/lungcancer/htm/

http://www.nlm.nih.gov/medlineplus/tutorials/ovariancancer/htm/

http://www.nlm.nih.gov/medlineplus/tutorials/ovariancancer/htm/

http://www.nlm.nih.gov/medlineplus/tutorials/whatisprostatecancer/htm/

http://www.nlm.nih.gov/medlineplus/tutorials/whatisprostatecancer/htm/

http://www.nlm.nih.gov/medlineplus/tutorials/skincancerandmelanoma/htm/













Author(s)


Brain Cancer1. Introduction2. The brain3. Cancer and its causes4. Symptoms5. Priimary brain tumors6. Metastatic brain tumors7. Diagnosis8. Surgery9. Adjuvant therapy10. Summaryhttp://collab.pharmatrain.eu/download/attachments/10879000/brain_tumors.pdf\\











Diabetes - Introduction



Resource Title Diabetes - Introduction- Medline Plus

URL http://www.nlm.nih.gov/medlineplus/tutorials/diabetesintroduction/htm/index.htm

Short Description Diabetes is a that affects millions of peopleevery year. This patient education tutorial isan interactive health education resource fromthe Patient Education Institute. Using animatedgraphics this tutorial explains a procedure orcondition in easy-to-read language. You can alsolisten to the tutorial.See also:Diabetes - Meal Planning, http://www.nlm.nih.gov/medlineplus/tutorials/diabetesmealplanning/htm/index.htm\\\\Diabetes - Eye Complications, http://www.nlm.nih.gov/medlineplus/tutorials/diabeteseyecomplications/htm/index.htm\\\\Diabetes - Foot Care, http://www.nlm.nih.gov/medlineplus/tutorials/diabetesfootcare/htm/index.htm\\



Medline Plus




Country other

Country (other) USA

Language English

Language (other)








http://www.nlm.nih.gov/medlineplus/tutorials/diabetesintroduction/htm/index.htm

http://www.nlm.nih.gov/medlineplus/tutorials/diabetesintroduction/htm/index.htm








Author(s)


Diabetes1. Introduction2. What is diabetes3. Signs and symptoms of diabetes4. Treatment options5. Controlling diabetes6. Hyperglycemia and hypoglycemia7. Complications of diabetes8. Summaryhttp://collab.pharmatrain.eu/download/attachments/10878996/diabetes_introduction.pdf







Date (yyyy-mm-dd) 2010-05-26, last update: 2010-05-26


http://collab.pharmatrain.eu/download/attachments/10878996/diabetes_introduction.pdf

http://collab.pharmatrain.eu/download/attachments/10878996/diabetes_introduction.pdf



Drug Abuse - Medline Plus



Resource Title Drug Abuse - Medline Plus

URL http://www.nlm.nih.gov/medlineplus/drugabuse.html

Short Description Drug abuse is a serious public health problemthat affects almost every community and family insome way. Each year drug abuse results in around40 million serious illnesses or injuries amongpeople in the United States. Abused drugs include

• Amphetamines• Anabolic steroids• Club drugs• Cocaine• Heroin• Inhalants• Marijuana• Prescription drugs



Medline Plus

Syllabus Context 10. Regulatory Affairs10.25 Drug abuse and dependence



Country other

Country (other) USA

Language English

Language (other)

Resource Type multimedia_documentvideo_included








http://www.nlm.nih.gov/medlineplus/drugabuse.html

http://www.nlm.nih.gov/medlineplus/drugabuse.html

http://www.nlm.nih.gov/medlineplus/methamphetamine.html

http://www.nlm.nih.gov/medlineplus/anabolicsteroids.html

http://www.nlm.nih.gov/medlineplus/clubdrugs.html

http://www.nlm.nih.gov/medlineplus/cocaine.html

http://www.nlm.nih.gov/medlineplus/heroin.html

http://www.nlm.nih.gov/medlineplus/inhalants.html

http://www.nlm.nih.gov/medlineplus/marijuana.html

http://www.nlm.nih.gov/medlineplus/prescriptiondrugabuse.html


JavaScriptFlash_Player


Server-side Technology(CMS/LMS type, etc.)




Author(s)


1. Basics2. Multimedia Tools3. Research4. References



Web-based resource with health information andfree access.







Drug Interactions



Resource Title Drug Interactions

URL http://www.aidsinfonet.org/fact_sheets/view/407?lang=eng

Short Description Prescription drug dosages need to be high enoughto fight a specific disease but low enough toavoid causing serious side effects. Taking otherprescription drugs, non-prescription (over-the-counter) or recreational drugs, herbal products, oreven food can cause large changes in the amountof the drug in your bloodstream. This is called a"drug interaction." It is serious because too muchof the drug in your bloodstream can cause seriousside effects, and too little can mean that the drugwill not work.

Context stand_alone


Syllabus Context 14. Therapeutics14.6 Drug interactions


e-Learning Provider (other) Medline Plus, aidsinfonet

Country other

Country (other) USA

Language English

Language (other)








Technical Requirements common_web_browserJavaScript


http://www.aidsinfonet.org/fact_sheets/view/407?lang=eng

http://www.aidsinfonet.org/fact_sheets/view/407?lang=eng






Author(s)


Drug Interactions

• WHAT ARE DRUG INTERACTIONS?• HOW DOES THE BODY PROCESS DRUGS?• HOW DO DRUGS INTERACT?• WHY DOES FOOD MATTER?• WHAT DRUGS CAUSE THE MOST

INTERACTIONS?• WHAT OTHER DRUGS NEED SPECIAL

ATTENTION?• WHAT ABOUT HERBAL PRODUCTS?• THE BOTTOM LINE



HTML presentation. Available for 12 languages.







Drug Safety - Medline Plus



Resource Title Drug Safety - Medline Plus

URL http://www.nlm.nih.gov/medlineplus/drugsafety.html

Short Description In the U.S., the government's Food and DrugAdministration (FDA) must approve any drug- whether it's prescription or over-the-counter- before it can be sold. The FDA evaluates thesafety of a drug by looking at side effects, howit's manufactured, results of animal testing andclinical trials, and more. The FDA also monitors adrug's safety after approval.



Medline Plus

Syllabus Context 11. Drug Safety, Pharmacovigilance andPharmacoepidemiology11.1 The role of the pharmaceutical professionalin drug safety and pharmacovigilance



Country other

Country (other) USA

Language English

Language (other)










http://www.nlm.nih.gov/medlineplus/drugsafety.html

http://www.nlm.nih.gov/medlineplus/drugsafety.html






Author(s)


1. Basics2. Multimedia Tools2.1 Videos3. Research3.1 Journal Articles4. References4.1 Dictionaries/Glossaries4.2 Organizations4.3 Law and Policy










H1N1 Flu or Swine Flu



Resource Title H1N1 Flu or Swine Flu

URL http://www.patient-education.com/h1n1.asp

Short Description In response to the spread of the H1N1 flu, thesevideos and tutorials will be provided free of charge(in English, Spanish, French, and Arabic).



Patient Education Institute

Syllabus Context


e-Learning Provider (other) Patient Education Institute

Country other

Country (other) USA

Language English

Language (other)














http://www.patient-education.com/h1n1.asp


Author(s)


H1N1 Flu (Swine Flu) - Reference Summary1. Introduction2. About viruses3. H1N1 Flu Infections4. Symptoms5. Emergency Signs6. Treatment7. Prevention tips8. Prevalence and Updates











Interactive Health Tutorials - Medline Plus



Resource Title Interactive Health Tutorials - Medline Plus

URL http://www.nlm.nih.gov/medlineplus/tutorials/

Short Description The tutorials are interactive health educationresources from the Patient Education Institute.Using animated graphics each tutorial explains aprocedure or condition in easy-to-read language.You can also listen to the tutorial.

Context stand_alone


Medline Plus

Syllabus Context



Country other

Country (other) USA

Language English

Language (other)













http://www.nlm.nih.gov/medlineplus/tutorials/



Author(s)


Interactive Health Tutorials1. Diseases and Conditions2. Tests and Diagnostic Procedures3. Surgery and Treatment Procedures4. Prevention and Wellness











International Health - Medline Plus



Resource Title International Health - Medline Plus

URL http://www.nlm.nih.gov/medlineplus/internationalhealth.html

Short Description Also called: Global health. The spread of a diseasedoesn't stop at a country's borders. With morepeople traveling to other countries and living incrowded cities, it's easier for germs to spread.Infectious diseases that start in one part of theworld can quickly reach another. Drug resistanceis on the rise, making it harder to treat certaindiseases. Natural and man-made disasters createrefugee populations with immediate and long-term health problems.Some of the major diseases currently affectingcountries around the globe include AIDS, malaria,pandemic/avian flu, and tuberculosis. Manycountries and health organizations are workingtogether and sharing information on these andother health issues.



Medline Plus

Syllabus Context



Country other

Country (other) USA

Language English

Language (other)








http://www.nlm.nih.gov/medlineplus/internationalhealth.html

http://www.nlm.nih.gov/medlineplus/internationalhealth.html

http://www.nlm.nih.gov/medlineplus/aids.html

http://www.nlm.nih.gov/medlineplus/malaria.html

http://www.nlm.nih.gov/medlineplus/birdflu.html

http://www.nlm.nih.gov/medlineplus/tuberculosis.html




Server-side Technology(CMS/LMS type, etc.)




Author(s)


1. Basics2. Multimedia Tools3. Research4. References










Parkinson's Disease - Medline Plus



Resource Title Parkinson's Disease - Medline Plus

URL http://www.nlm.nih.gov/medlineplus/tutorials/parkinsonsdisease/htm/index.htm

Short Description Parkinson's disease is a common disease thataffects muscle control. This disease affects abouthalf a million people every year. The symptomsof Parkinson's disease are easily treated. Thispatient education tutorial is an interactive healtheducation resource from the Patient EducationInstitute. Using animated graphics this tutorialexplains a procedure or condition in easy-to-readlanguage. You can also listen to the tutorial.



Medline Plus




Country other

Country (other) USA

Language English

Language (other)










http://www.nlm.nih.gov/medlineplus/tutorials/parkinsonsdisease/htm/index.htm

http://www.nlm.nih.gov/medlineplus/tutorials/parkinsonsdisease/htm/index.htm






Author(s)


Parkinson's Disease1. Introduction2. Anatomy3. Symptoms4. Treatment5. Conclusionhttp://collab.pharmatrain.eu/download/attachments/10878978/parkinsons_disease.pdf!dopamine_vs_acetylcholine.png!With lessdopamine than normal, there is less dopaminethan acetylcholine in the brain. This imbalancecauses the symptoms of Parkinson's disease. Thegoal of treatment for Parkinson's disease is tobalance dopamine and acetylcholine in the brain.









http://collab.pharmatrain.eu/download/attachments/10878978/parkinsons_disease.pdf

http://collab.pharmatrain.eu/download/attachments/10878978/parkinsons_disease.pdf



Smoking - The Facts



Resource Title Smoking - The Facts - Medline Plus

URL http://www.nlm.nih.gov/medlineplus/tutorials/smokingthefacts/htm/index.htm

Short Description Smoking is a major public health problem. Abouthalf a million deaths per year in the USA are dueto smoking. These deaths happen as a result ofcancers, breathing problems, strokes, and manyother smoke-related health problems.



Medline Plus

Syllabus Context



Country other

Country (other) USA

Language English

Language (other)












http://www.nlm.nih.gov/medlineplus/tutorials/smokingthefacts/htm/index.htm

http://www.nlm.nih.gov/medlineplus/tutorials/smokingthefacts/htm/index.htm




Author(s)


Smoking - The Facts1. Interactive tutorial2. Self playing tutorial3. Text summary











Tinnitus - Medline Plus



Resource Title Tinnitus - Medline Plus

URL http://www.nlm.nih.gov/medlineplus/tutorials/tinnitus/htm/index.htm

Short Description Tinnitus causes a person to hear a persistentsound in the ear when no sound exists.



Medline Plus

Syllabus Context



Country other

Country (other) USA

Language English

Language (other)














http://www.nlm.nih.gov/medlineplus/tutorials/tinnitus/htm/index.htm

http://www.nlm.nih.gov/medlineplus/tutorials/tinnitus/htm/index.htm


Author(s)


Tinnitus1. Interactive tutorial2. Self playing tutorial3. Text summary



Web-based multimedia (Flash, PDF) presentation,explaining Tinnitus.







Understanding Clinical Trials



Resource Title Understanding Clinical Trials

URL http://clinicaltrials.gov/ct2/info/understand

Short Description Choosing to participate in a clinical trial is animportant personal decision. The followingfrequently asked questions provide detailedinformation about clinical trials. In addition, itis often helpful to talk to a physician, familymembers, or friends about deciding to join a trial.After identifying some trial options, the next stepis to contact the study research staff and askquestions about specific trials.



Medline Plus




Country other

Country (other) USA

Language English

Language (other)












http://clinicaltrials.gov/ct2/info/understand




Author(s)


Frequently asked questions:* What is a clinical trial?* Why participate in a clinical trial?* Who can participate in a clinical trial?* What happens during a clinical trial?* What is informed consent?* What are the benefits and risks of participatingin a clinical trial?* What are side effects and adverse reactions?* How is the safety of the participant protected?* What should people consider beforeparticipating in a trial?* What kind of preparation should a potentialparticipant make for the meeting with theresearch coordinator or doctor?* Does a participant continue to work with aprimary health care provider while in a trial?* Can a participant leave a clinical trial after it hasbegun?* Where do the ideas for trials come from?* Who sponsors clinical trials?* What is a protocol?* What is a placebo?* What is a control or control group?* What are the different types of clinical trials?* What are the phases of clinical trials?* What is "expanded access"?



HTML presentation.







Understanding Medical Words



Resource Title Understanding Medical Words

URL http://www.nlm.nih.gov/medlineplus/medicalwords/

Short Description A tutorial from the National Library of Medicine(NLM)



Medline Plus

Syllabus Context



Country other

Country (other) USA

Language English

Language (other)














http://www.nlm.nih.gov/medlineplus/medicalwords/

http://www.nlm.nih.gov/medlineplus/medicalwords/


Author(s)


Understanding Medical Words1. Introduction2. Words roots3. Beginnings and endings4. Quiz time5. Abbreviationshttp://www.nlm.nih.gov/medlineplus/medicalwords.html\\ Appendix A: Word Partsand What They Mean http://www.nlm.nih.gov/medlineplus/appendixa.html\\Appendix B: Some common abbreviations, http://www.nlm.nih.gov/medlineplus/appendixb.html\\Medical Dictionary, http://www.nlm.nih.gov/medlineplus/mplusdictionary.html\\



Web-based multimedia (Flash) presentation.




Date (yyyy-mm-dd) 2010-05-26, last update: 2010-05-26




MRC, Medical Research Council



Resource Title MRC: Medical Research Council

URL http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/RegulatorySupportCentre/Training/index.htm

Short Description The Regulatory Support Centre (RSC) providestraining on regulation, ethics and governancetopics for MRC staff at units throughout theUK. RSC tries to ensure that all of the trainingconforms to the UKCRC Governance Trainingquality criteria.RSC also offers e-learning modules on IRAS andhuman tissue legislation.

Context stand_alone


Syllabus Context 8. Ethics and Legal Issues10. Regulatory Affairs


e-Learning Provider (other) MRC

Country other

Country (other) UK

Language English

Language (other)












http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/RegulatorySupportCentre/Training/index.htm





Registration (details) To book a course please contact Sue Salkeld([email protected]) at the SharedServices Centre.

Author(s)


Training courses in 2010Date Course (Location)-------------------------------------------------2010-10-05 Consent for tissue (LMB,Cambridge)2010-10-05 Good clinical practice for non-trialists(LMB,Cambridge)2010-11-09 Human Tissue Act (CSC, London)2010-11-10 Research data and confidentiality(CTU, London)



Web Portal.








Consent for tissue - collecting, storing and using human tissue



Resource Title Consent for tissue - collecting, storing andusing human tissue

URL http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC006165

Short Description Document LibraryConsent for tissue - collecting, storing and usinghuman tissueIssued: 24 Jun 2009Training session will last 2 hours and will consistof:1. PowerPoint presentations with interactivediscussion - 45 min (Ethical and legal principles ofconsent to collect, use and store human tissue).2. Workshop activities - working through theconsent requirements in a couple of specific 'reallife' scenarios involving the collection and useof tissue from patients, healthy volunteers andcolleagues.



MRC




Country other

Country (other) UK

Language English

Language (other)








Technical Requirements

http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC006165



common_web_browser JavaScript Adobe_ReaderFlash_Player

Technical Requirements (other) Microsoft PowerPoint





Author(s)


Overview of courseTraining session will last 2 hours and will consistof:1. PowerPoint presentations with interactivediscussion - 45 min (Ethical and legal principles ofconsent to collect, use and store human tissue).2. Workshop activities - working through theconsent requirements in a couple of specific 'reallife' scenarios involving the collection and useof tissue from patients, healthy volunteers andcolleagues.Training materials used include:Presentations (made available as handouts, withspace for notes)Training pack containing:o copies of presentations;o 'Real life' scenarios to be worked through inworkshops;o Human Tissue Act: consent summary (preparedin consultation with HTA)o Extract from EMEA Good Clinical Practiceguidance on consento Where to get help and further informationTarget audienceMRC employed staff who take consent frompatients or healthy volunteers to collect, store anduse tissue for research studies. Other staff whorecruit patients or healthy volunteers to MRC Unitcore research activity. This training is offered inaddition to a day long course on consent whichcovers consent requirements in a wider variety ofresearch contexts and in significantly more detail(for more information on this course visit http://www.mrc.ac.uk/regulatorysupportcentre).Training outcomesFollowing training, attendees will:1. Understand the ethical concept of 'autonomy'.2. Know and understand the three common lawprinciples of consent: exploring what is meant by'voluntary', 'informed' and 'competent'.3. Have an overview of what the Human TissueAct 2004 demands in terms of consent to collect,store and use samples of human tissue (from theliving and the dead).4. Understand what common law requires interms of consent when collecting tissue from

http://www.mrc.ac.uk/regulatorysupportcentre

http://www.mrc.ac.uk/regulatorysupportcentre


living humans (patients, healthy volunteers andcolleagues).5. Know how to recruit vulnerable individuals tostudies involving the collection, storage and use oftissue.6. Understand how consent should be indicated.7. Know where to go for help and further guidanceon consent to take part in research.This training will not cover the details of GCP(Good Clinical Practice) with respect to requireddocumentation or precise wording to be used inconsent forms. However brief consideration ofhow consent can be indicated will be given, andwill be explored in light of what consent means (inlaw).MRC Regulatory Support Centre, March 2009 1/1


2 hours


Web Portal, Document Library




Date (yyyy-mm-dd) 2010-08-12 11:31:41, Last update 2010-08-12




Good clinical practice for non-clinical trialists



Resource Title Good clinical practice for non-clinical trialists


Short Description Good clinical practice for non-clinical trialistsIssued: 01 Aug 2009Primary audience: ResearchersDocument SummaryApplicable to all MRC employed staff who conductresearch involving humans, their tissue or data,as well as those with responsibility for designingand implementing research governance processeswithin the MRC.



MRC




Country other

Country (other) UK

Language English

Language (other)

















Author(s)


DRAFTGood clinical practice for non-clinical trialistsOverview of courseTraining session will last 2 hours and will consistof:1. PowerPoint presentations - 30 min (broken up)covering the principles of GCP2. Workshop activities and interactive discussions- dispersed throughout the session to illustratepractical implementation of the principles ineveryday working3. Ample time for questionsTraining materials used will include:Presentations (made available as handouts, withspace for notes)Training pack containing:o The 13 principles of GCP - in fullo Copies of scenarios and practical exercises (tobe used during the session)o Where to find help - including space for localcontact details (MRC, NHS and University)Target audienceThis course will be applicable to all MRC employedstaff who conduct research involving humans,their tissue or data, as well as those withresponsibility for designing and implementingresearch governance processes within the MRC.Anyone involved in clinical trials of investigationalmedicinal products (the planning, initiation,management and closure) should complete GCPtraining designed specifically for trialists, whichcovers the requirements of the Medicines forHuman Use (Clinical Trials) Regulations.Training outcomesFollowing training, attendees will:• Know the 13 principles of Good Clinical Practice,and have an overview of who is responsible forimplementing the principles (as defined in theResearch Governance Framework)• Have an overview of the Declaration of Helsinkiand Research Governance Framework• Understand the concept of research 'sponsor'• Have an overview of the major ethical principlesunderpinning research involving humans, theirtissue or data (including those involved in consentand confidentiality)• Know how to indentify when specific regulatoryrequirements apply• Understand what is meant by 'risk assessment'and have explored common threats associatedwith research involving humans• Understand how the quality of researchprotocols and the quality of research data is


assured, and explore what is meant by 'quality'and 'quality assurance'• Have an overview of MRC / NHS / Universitygovernance processes, including arrangementsfor indemnity - Honorary contracts and researchpassports• Be encouraged to consider their training needsand those of the people they have managementor supervisory responsibility.This course will not cover detailed informationon the application of GCP to clinical trials ofinvestigational medicinal products. The course willalso not cover specific aspects of how researchgovernance is implemented by individual sponsorsor host organisations (i.e. it will not cover specificinformation on sponsor Standard OperatingProcedures). However, the course should supportthose involved in designing and implementingresearch governance processes.How the course will be developedThis course will be developed by the MRCRegulatory Support Centre, with input from:MRC Head Office, MRC staff with responsibility forimplementing and managing research governanceprocesses within units, NHS & University partners,Scottish Clinical Research Training Group, andUKCRC Regulatory Training Co-ordination Group


2 hours










Human Tissue Act - training for investigators



Resource Title Human Tissue Act - training for investigators


Short Description Document LibraryHuman Tissue Act - training for investigatorsIssued: 20 Feb 2009Document SummaryThis training is tailored for anyone in the MRCwho uses human tissue for research or whois responsible for the administration and/ormanagement of human sample collections held bythe MRC.



MRC




Country other

Country (other) UK

Language English

Language (other)

















Author(s)


Overview of courseTraining session will last approx 2 hours and willconsist of:1. PowerPoint presentation with interactivediscussion - 1 hour (the importance of tissuetracking will be demonstrated by a short audienceparticipation exercise).2. Workshop activities - 1 hour (looking at 'reallife' examples).Training materials used include:Presentations (made available as handouts, withspace for notes)Training pack containing:o copies of summaries of the legal position withrespect to consent, licensing, import and export,disposal, DNA analysis and in Scotland (producedby MRC Regulatory Support Centre (RSC) inconsultation with the Human Tissue Authority(HTA) and Scottish Executive);o decision-making tree for consent and licensing(also produced by RSC in consultation with HTA);o an overview of places to get further help(including local help, MRC policy, nationalguidance and access to the UKCRC AdviceService)o 'Real life' scenarios, posed to explore how theHuman Tissue Act impacts on decisions 'at thebench'Target audienceThis training is specifically tailored for anyone inthe MRC who uses human tissue for research orwho is responsible for the administration and/ormanagement of human sample collections held bythe MRC. The training is designed to be practicaland directly applicable to those working withhuman tissue 'at the bench', and will not explicitlycover the process of obtaining informed consent(this is provided separately - see below).Training outcomesFollowing the training presentation session (whichincludes some interaction), attendees should beaware of:1. where to find information and/or help withhuman tissue regulations (local, MRC and nationallevel);2. what is meant by 'relevant material' and 'bodilymaterial';3. what is meant by 'existing holdings';4. that research is an activity covered by theHuman Tissue Act 2004;5. the importance of conducting freezer audits orother audits of stored tissue;


6. the importance of consent to the use andstorage of human tissue -and knowledge of whenthe law requires consent to be in place;7. the importance of gaining NHS Research EthicsCommittee (REC) approval for studies;8. the need for tissue tracking SOPs, and theresponsibilities they all have for supporting thedevelopment of these SOPs and working to them.Following the workshop session attendees shouldunderstand:1. when consent is required under the HumanTissue Act (consideration will not be made ofconsent requirements in adults not able toconsent for themselves);2. the exemptions to consent provisions(i.e. existing holdings, ethics approval andanonymisation and importation of tissue);3. exemption to licensing provisions (i.e. ethicalapproval from an appropriate REC).Specifically this training will not cover the detailsof how to take consent, how consent should bedocumented or who can give consent; anothersession specifically aimed at investigators andothers with patient/participant contact has beendeveloped (available also through the coretraining programme).


2 hours










Research and human tissue legislation



Resource Title Research and human tissue legislation

URL http://www.rsclearn.mrc.ac.uk/

Short Description Distance learningIRAS e-learningSuitable for anyone doing health and social/community care research, the IRAS e-learningmodule leads you through the process of makingapplications using the IRAS system. This modulewas developed by the Regulatory Support Centre(RSC) on behalf of the UK Clinical ResearchCollaboration and the IRAS Partners, and is free toall.



IRAS e-learning, MRC




Country other

Country (other) UK

Language English

Language (other)











http://www.rsclearn.mrc.ac.uk/





Author(s)


Research and human tissue legislation e-learning

• Following completion of the module, you will:o Have an overview of Human Tissue Act2004 and Human Tissue (Scotland) Act 2006o Know when the Acts applyo Understand what constitutes best practiceo Be armed with top tips to supportcomplianceo Know where to find help.Specifically this training will not cover thedetails of how to take consent, how consentshould be documented or who can giveconsent, a further module is being developedto cover this.


45 min


Web-based flash presentation (ArticulatePresenter)








National Health Service, UK


The NHS in England http://www.nhs.uk/NHSEngland/Pages/NHSEngland.aspx

http://www.nhs.uk/NHSEngland/Pages/NHSEngland.aspx


Clinical trials and medical research



Resource Title Clinical trials and medical research

URL http://www.nhs.uk/Conditions/Clinical-trials/Pages/Introduction.aspx

Short Description Research and clinical trials are an everyday part ofthe NHS. The people who do research are mostlythe same doctors and other health professionalswho treat people. They want to find better ways oflooking after patients and keeping people healthy.Health research covers a range of activities, fromwork in a scientific laboratory to carefully notingpatterns of health and disease and developingnew treatments.Health and social care research looks intomany different issues, from illness, disease anddisability to the way that health and social careservices are provided by the NHS.

Context stand_alone




e-Learning Provider (other) National Health Service

Country other

Country (other) UK

Language English

Language (other)









http://www.nhs.uk/Conditions/Clinical-trials/Pages/Introduction.aspx

http://www.nhs.uk/Conditions/Clinical-trials/Pages/Introduction.aspx


Adobe_ReaderFlash_Player






Author(s)


1. Why do research?2. Where is research done?3. How is it funded?4. How can I get involved?



Web-based multimedia presentation.




Date (yyyy-mm-dd) 2010-05-20; last update:2010-05-20




NHS Education for Scotland (NES), eLearning Resources

This page last changed on Jan 31, 2011 by nhaider.


Resource Title NHS Education for Scotland (NES), eLearningResources

URL http://www.nes.scot.nhs.uk/disciplines/pharmacy/learning-resources/elearning-

Short Description On this page there are a variety of e learningresource, covering a variety of topics.

• Medicines in a chemical, biological,radiological or nuclear incident.

• Flavours of Pharmaceutical Public Health• Medicines and Mothers - Challenges in

Breastfeeding• Pharmacogenetics - Genetic approaches to

therapy• Raising the Issue of Smoking• Smoke free me, Smoke free You - the

pharmacy model

Context stand_alone


Syllabus Context


e-Learning Provider (other) NHS Education for Scotland (NES)

Country other

Country (other) UK

Language English

Language (other)










http://www.nes.scot.nhs.uk/disciplines/pharmacy/learning-resources/elearning-

http://www.nes.scot.nhs.uk/disciplines/pharmacy/learning-resources/elearning-





Registration (details) To register for TOXBASE as a UK medicalprofessional use this web link: http://www.toxbase.co.uk/

Author(s)


1. Emergency PlanningMedicines in a Chemical, Biological, Radiological orNuclear Incident CBRN.2. Public HealthFlavours of Pharmaceutical Public Health3. BreastfeedingMedicines and Mothers-Challenges inBreastfeeding4. PharmacogeneticsPharmacogenetics:Genetic approaches to therapy.5. Tobacco controlPart 1: Raising the Issue of SmokingPart 2: Smoke free Me, smoke free You - thepharmacy model



web-portal NHS Education for Scotland (NES). Itcontains e.g. eLearning Resources,






Comments

Flavours of Pharmaceutical Public Health: http://www.nes.scot.nhs.uk/disciplines/pharmacy/supporting-the-pharmacy-contract-/pharmaceutical-public-health-service

Contents:

• Introduction (.pdf)• Breastfeeding (.pdf)• Female Health (.pdf)• Immunisation (.pdf)• Male Health (.pdf)• Sexual Health and Hormonal Contraception (.pdf)• Substance Misuse (.pdf)• Travel Health (.pdf)• Weight Management (.pdf)• Smoking Cessation (.pdf)

http://www.toxbase.co.uk/

http://www.toxbase.co.uk/


http://www.nes.scot.nhs.uk/disciplines/pharmacy/supporting-the-pharmacy-contract-/pharmaceutical-public-health-service

http://www.nes.scot.nhs.uk/disciplines/pharmacy/supporting-the-pharmacy-contract-/pharmaceutical-public-health-service


Posted by nhaider at Feb 02, 2011......................................................................................................................................................................


pharmaSquare


pharmasquare http://www.p2.unibas.ch/

http://www.p2.unibas.ch/


pharmaSquare Courses



Resource Title pharmaSquare Courses

URL http://www.p2.unibas.ch/

Short Description e-learning platform of Pharmaceutical Sciences.

Context stand_alone


Syllabus Context


e-Learning Provider (other) pharmasquare

Country Switzerland

Country (other)

Language other

Language (other) German













Registration (details) To use pharmasquare, you must register. http://www.p2.unibas.ch/Register/Register.php

Author(s)

http://www.p2.unibas.ch/

http://www.p2.unibas.ch/Register/Register.php

http://www.p2.unibas.ch/Register/Register.php



English Version (google translator)Courses

1. Health Care Courses Health Sciences:headache

2. E-lecture drug interactions3. Seminar on Drug Discovery and

Development4. more ...

Pharmaceutical collections5. Glossary , structures , medicinal and

poisonous plantsDemos (free access)

6. Learning module flu...



Web-based courses





http://translate.google.com/translate?js=y&prev=_t&hl=de&ie=UTF-8&layout=1&eotf=1&u=http%3A%2F%2Fwww.p2.unibas.ch%2F&sl=de&tl=en



PharmExec.com - Pharmaceutical Executive Podcasts



Resource Title PharmExec.com - Pharmaceutical ExecutivePodcasts

URL http://pharmexec.findpharma.com/podcasts

Short Description Listen to interviews with 12 of these 27innovative executives who are helping take thepharmaceutical industry to the next level.

Context stand_alone


Syllabus Context


e-Learning Provider (other) PharmExec.com

Country other

Country (other) USA

Language English

Language (other)









Technical Requirements (other) iTunes




Registration (details) Pharmaceutical Executive Magazine641 Lexington Avenue, 8th FloorNew York, NY 10022

http://pharmexec.findpharma.com/podcasts


Fax: 212.951.6604

Author(s)


1. Emerging Pharma Leadership Awards 2010Sponsored By Cegedim Relationship Management2. Trends in Patient Access: How Health Reform,Cost of Care and Stakeholder Response Will ShapePharmaceutical Product UtilizationSponsored By AmerisourceBergen Specialty Group3. Industry Audit & Company of the YearSponsored By Covidien4. The Changing Relationship between Pharmaand Managed CareSponsored By AmerisourceBergen Specialty Group



Podcasts - A Service of PharmExec.com




Date (yyyy-mm-dd) 2010-11-15 12:08:10




Postgraduate Coursework - Drug Development - UNSW



Resource Title Postgraduate Coursework - DrugDevelopment

URL http://www.handbook.unsw.edu.au/postgraduate/programs/2011/5504.html

Short Description Program DescriptionThe Graduate Diploma in Drug Development is<b>a part-time distance learning program</b>that takes a minimum of two years to complete.The program is designed for persons wishing topursue careers that relate to the development andsafe use of medicines. Career opportunities existin the pharmaceutical manufacturing industry,government and in research institutions such asuniversities.Health care professionals interested in developingnew medicines and improving the use of existingmedicines will find the program of value. Theextensive range of electives enables the candidateto specialise in particular areas such as thediscovery of new medicines; regulatory affairs;clinical trials; market development; medicaldepartment administration; preclinical studies,etc.To fulfil the program requirements, students mustsatisfactorily complete eight core courses, eachworth 6 units of credit.

Context stand_alone


Syllabus Context 1. Discovery of Medicines


e-Learning Provider (other) The University of New South Wales

Country other

Country (other) Australia

Language English

Language (other)





http://www.handbook.unsw.edu.au/postgraduate/programs/2011/5504.html

http://www.handbook.unsw.edu.au/postgraduate/programs/2011/5504.html


Copyright/Licence (details) FeesFor information regarding fees for UNSWprograms, please refer to the followingwebsite: https://my.unsw.edu.au/student/fees/FeesMainPage.htmlAcademic RulesPlease refer to the Program Structure aboveand contact [email protected] for furtherinformation.



Technical Requirements common_web_browser JavaScript





Registration (details) Academic RulesPlease refer to the Program Structure aboveand contact [email protected] for furtherinformation.FeesFor information regarding fees for UNSWprograms, please refer to the followingwebsite: https://my.unsw.edu.au/student/fees/FeesMainPage.htmlArea(s) of Specialisation

• Drug Development• Physiology and Pharmacology• Sports Medicine

Author(s)


Program StructureProgram OverviewIn the first year of study, the courses within theprogram start with a general overview of thedrug development process, with a focus on drugdiscovery, chemistry relevant to drug discoveryand development issues, pharmacokinetics andcodes of practices and standards, and regulationof medicines in Australia. Significant attentionis given to understanding the pharmacologyand pharmacodynamic properties of drugs andhow this relates to pharmacokinetics also. Thisis explored further in drug safety assessmentsleading up to the first human clinical testing. Asthe story of development of a drug from discoverythrough to human testing progresses in theprogram we deal with the important principlesof clinical trial practice and management.This includes protocol development, obtainingregulatory and ethical approval, planningtrial recruitment, data management and datareporting. The course closes with an introduction

https://my.unsw.edu.au/student/fees/FeesMainPage.html





to the Law as it pertains to the developmentof new drugs. Emphasis is upon AdministrativeLaw as it applies to the review of regulatorydecisions provided by the Therapeutic GoodsAct. The processes involved in the regulationof medicines, including prescription and non-prescription medicines, and medical devices withinAustralia are discussed in detail, along with therequirements of other international agencies.In the second year of the program, studentsexamine issues related to the formulation ofnew medicines, with a strong focus on quality ofproduct, examination of impurities and stabilityof the new medicine. The program also includesmethods of assessment and prevention of adverseevents, reporting responsibilities and the useof safety information databases. Protection ofintellectual property relevant to the industryis examined. Students conclude their programby examining the use of statistics in design ofclinical trials and assessment of data, and theimportance of decision making throughout thedrug development process.Year 1Session 1

• PHAR9101 Principles of Drug Action (6 UOC)• PHAR9120 Clinical Development of Med (6

UOC)Session 2

• PHAR9104 Legal/Regulatory Devlp of Med (6UOC)

• PHAR9127 Safety and Efficacy (6 UOC)Year 2Session 1

• PHAR9102 Pharm. Develp of New Medicines(6 UOC)

• PHAR9121 Postmarketing Development Med(6 UOC)Session 2

• PHAR9103 Biostatistics and Trial Design (6UOC)

• PHAR9128 R & D (6 UOC)


2 Years





Date (yyyy-mm-dd) 2010-12-16 12:00:03




SeerPharma - e-Learning



Resource Title SeerPharma - e-Learning

URL http://www.seerpharma.com.au/discover/index.html

Short Description DISCover e-learning: Interactive, web-basedtrainingOptimise your training budget to deliver cost-effective, 24/7, state-of-the-art life scienceseducation and training, on demand. DISCoverdelivers best-practice, effective e-learning to theworksite.DISCover has been developed by industry expertscovering regulatory compliance to all majorinternational cGMPs, such as FDA, EU, PIC/s, TGA,and ISO 13485/CFR 820.DISCover modules combine the impact of expertcontent and multimedia to make the learningexperience simple, consistent, more engaging,and more memorable.

Context stand_alone


Syllabus Context


e-Learning Provider (other) SeerPharma

Country other

Country (other) Australia

Language English

Language (other)









http://www.seerpharma.com.au/discover/index.html

http://www.seerpharma.com.au/discover/index.html







Author(s)


Modules available:DISCover has an extensive catalogue of e-learningmodules, including series on1. GMP2. QC3. Validation4. Medical Devices5. IS/IT6. Laboratory Practices.



Web-based e-Learning provider.








SouthWest Training Institute - Free Preview Resources



Resource Title SouthWest Training Institute - Free PreviewResources

URL http://www.swtinstitute.com/

Short Description Southwest Training Institute, a company since1988, created by Mary Jo Huard. The TrainingInstitute develops and delivers WORKSHOPSon a broad variety of topics, facilitates strategicMEETINGS, provides TURN-KEY training products,as well as conducts ASSESSMENTS of all types--including 360-Performance Feedback.

Context stand_alone


Syllabus Context


e-Learning Provider (other) SouthWest Training Institute

Country other

Country (other) USA

Language English

Language (other)













http://www.swtinstitute.com/



Author(s)


FREE preview Leadership Solutions Curriculumparticipant workbooks:1. Essential Skills of Leadership: http://www.eslflipbook.vitallearninglink.com/2. Supporting Change: http://www.scflipbook.vitallearninglink.com/3. Providing Performance Feedback: http://www.ppfflipbook.vitallearninglink.com/4. Individual Leadership Needs Assessment:http://www.swtiassessment.vitallearninglink.com/5. Leadership, Customer Service, Productivity, &Sales Courseware Family:http://www.vital-online.com/swtraininginst/demo.htmlESSENTIAL SKILLS OF COMMUNICATING2. To access Business Skills & Desktop ComputingCoursewareCAREER DEVELOPMENT---RECONDITION FORSUCCESSEFFECTIVE PRESENTATIONS---DEVELOP ANEFFECTIVE MESSAGEEXCEL 2007---CREATING A WORKSHEET



The Web-portal of the SouthWest TrainingInstitute with some free preview materials andcourses






Comments

The full document provided by Anthony Chan is available as PDF here: Full document (PDF)

Posted by nhaider at Mar 09, 2011......................................................................................................................................................................

http://www.eslflipbook.vitallearninglink.com/

http://www.eslflipbook.vitallearninglink.com/

http://www.scflipbook.vitallearninglink.com/

http://www.scflipbook.vitallearninglink.com/

http://www.ppfflipbook.vitallearninglink.com/

http://www.ppfflipbook.vitallearninglink.com/

http://www.swtiassessment.vitallearninglink.com/

http://www.vital-online.com/swtraininginst/demo.html

http://www.vital-online.com/swtraininginst/demo.html


http://collab.pharmatrain.eu/download/attachments/33554435/SouthWest_Training_Institute_2011_Free_Products_Directory.pdf


Synergix Ltd - Drug Design - drugdesign.com



Resource Title Synergix Ltd. - Drug Design -drugdesign.com

URL http://www.drugdesign.com

Short Description The Molecular Conceptor Learning Series is aninteractive computer-based learning suite thatteaches the principles and techniques used ineveryday drug discovery thus providing thecomprehensive training necessary to face eventhe toughest drug design challenges.

Context stand_alone




e-Learning Provider (other) drugdesign.com

Country other

Country (other) Israel

Language English

Language (other)

Resource Type multimedia_document practicing_toolself_assessment











http://www.drugdesign.com



Registration (details) http://www.drugdesign.com/web/company/contact_formDepartment EmailGeneral Information and [email protected] and Technical [email protected] Information [email protected] and Pricing [email protected] Relations [email protected] you prefer to speak directly with a member ofour sales team,please call us at this number:USA/Canada Toll Free (866) 995-4272

Author(s)


1. Medicinal Chemistry2. Cheminformatics3. Drug Design4. Structural Bioinformatics5. Practical Drug Discovery: Case Studies



Web-portal of Synergix Ltd., 1996-2011






http://www.drugdesign.com/web/company/contact_form

http://www.drugdesign.com/web/company/contact_form



TEDDY NoE e-Learning Platform



Resource Title TEDDY NoE e-Learning Platform

URL http://www.teddylearning.org/

Short Description The Task-force in Europe for Drug Developmentfor the Young (TEDDY) is a Network of Excellence(NoE) funded under the Sixth EU FrameworkProgramme for Research and TechnologicalDevelopment (FP6).The overall aim of TEDDY is promoting theavailability of safe and effective medicinesfor children in Europe by integrating existingexpertise and good practices, as well asstimulating further developments.In this contest has been created the TEDDY e-learning Platform aimed to distribute to differentstackholders updated Information on Medicinesfor children with particular reference to theirbetter use, valuable effects and possible risks.Taking advantage of the new possibilities offeredby the information technologies, this courseis entirely online, combining the use of webtechnology, hypertexts and other instruments(e-mail) allowing continuous teacher-participantinteraction.

Context stand_alone




e-Learning Provider (other) TEDDY

Country other

Country (other) Italy

Language English

Language (other)







http://www.teddylearning.org/








Registration (details) Contact and registration:http://www.teddyoung.org/index.php?page=static&action=view&elementID=5Registrationform:http://www.teddylearning.org/RegistrationForm.aspx

Author(s)


Content:1. Clinical Trials investigating drugs in children2. Ethics in paediatric clinical trials3. Adverse Drug Reaction in children4. Paediatric RegulationCourses:http://www.teddylearning.org/Courses.aspx1. CHILDREN ARE NOT LITTLE ADULTS2. THE EUROPEAN PAEDIATRIC REGULATION3. PAEDIATRIC STATUS AND OFF-LABEL USE OFDRUGS IN CHILDREN4. CLINICAL TRIALS INVOLVING CHILDREN -Methodological aspects5. CLINICAL TRIALS INVOLVING CHILDREN -Ethical aspects6. PRESCRIBE SAFER AND EFFICACIOUSLY INCHILDHOOD7. PHARMACOVIGILANCE AND DRUG ADVERSEEFFECTS8. INNOVATIVE MEDICINES FOR CHILDREN9. THERAPEUTIC NEEDS IN THE PAEDIATRICPOPULATION



Web-based e-learning courses.PDF-Downloads: http://www.teddyoung.org/index.php?page=download




Date (yyyy-mm-dd) 2010-05-12 12:18:16

http://www.teddyoung.org/index.php?page=static&action=view&elementID=5


http://www.teddylearning.org/RegistrationForm.aspx


http://www.teddylearning.org/Courses.aspx

http://www.teddyoung.org/index.php?page=download

http://www.teddyoung.org/index.php?page=download


CHILDREN ARE NOT LITTLE ADULTS



Resource Title CHILDREN ARE NOT LITTLE ADULTS

URL http://www.teddylearning.org/Courses.aspx

Short Description Aimed to describe the impact of paediatricpharmacological characteristics in the medicinaldevelopmental process. Contents: PaediatricAges and body characteristics, Differences withadults relevant for ADME, Differences amongdifferent paediatric ages, ADME description in allthe paediatric ages, ADME in prenatal-neonatalage, Effects on specific pharmacological classes






Country other


Language English

Language (other)















Registration (details) Contact and registration:http://www.teddyoung.org/index.php?page=static&action=view&elementID=5Registration Form:http://www.teddylearning.org/RegistrationForm.aspx

Author(s) Adriana Ceci, Marcello Tonini


Modules (graphic presentations supported byaudio comments + textbooks)INTRODUCTION TO COURSE (6 slides) - no loginModule 1: Paediatric ages and body characteristics(24 slides)Module 2: Children's response to drugs (37 slides)Module 3: Focusing on prenatal-neonatal age (22slides)CONLUSIONS (11 slides)Test (20 Questions)



Web-based e-learning course.




Date (yyyy-mm-dd) 2010-05-12 12:33:18








CLINICAL TRIALS INVOLVING CHILDREN - Methodological aspects



Resource Title CLINICAL TRIALS INVOLVING CHILDREN -Methodological aspects


Short Description Aimed to describe regulatory and methodologicalaspects to conduct clinical trial in children.Contents: a roundup of features and rulesgoverning clinical research; the maincharacteristics and also difficulties of thepaediatric research; European regulatory andprocedural guidance, aimed to stimulate a correctpaediatric clinical research (Directives, scientificand regulatory guidelines, such as the ICH TopicE 11 Guideline entitled "Clinical Investigation ofMedicinal Products in the Paediatric Population");new methodological approaches of conductingclinical trial in children; the importance ofperforming paediatric trials and their well-conducting and, in the same time, of avoidingunnecessary trials in children.



Syllabus Context 7. Clinical Trials10. Regulatory Affairs



Country other


Language English

Language (other)















Registration (details) Contact and registration:http://www.teddyoung.org/index.php?page=static&action=view&elementID=5Registration form:http://www.teddylearning.org/RegistrationForm.aspx

Author(s) Paola Baiardi


Modules (graphic presentations supported byaudio comments + textbooks )INTRODUCTION TO COURSE (6 slides) - no loginModule 1: Introduction to clinical trials (30 slides)Module 2: Why to perform paediatric clinical trials(43 slides)Module 3: How to conduct paediatric research (40slides)Module 4: Key aspects of paediatric protocols (23slides)CONLUSIONS (15 slides)Test (20 Questions)







Date (yyyy-mm-dd) 2010-05-12 12:52:01








THE EUROPEAN PAEDIATRIC REGULATION



Resource Title THE EUROPEAN PAEDIATRIC REGULATION


Short Description Aimed to illustrate the challenge offered by thefirst Paediatric Regulation in Europe definedby the EMEA establishing procedures for thedevelopment of medicines for children. Contents:the EMEA's role in medicine development andthe main regulatory principles; the EuropeanMarketing Authorisation for medicines for humanuse; the current status of paediatric medicines;the key points of the Paediatric Regulation withparticular reference to PIP application and PDCOevaluation procedure.



Syllabus Context 10. Regulatory Affairs



Country other


Language English

Language (other)















Registration (details) Contact and registration:http://www.teddyoung.org/index.php?page=static&action=view&elementID=5Registration form:http://www.teddylearning.org/RegistrationForm.aspx

Author(s) Mariana Catapano


Modules (graphic presentations supported byaudio comments + textbooks )INTRODUCTION TO COURSE (6 slides) - no loginModule 1: Marketing Authorisation procedures (40slides)Module 2: Paediatric Regulation (38 slides)Module 3: Paediatric Investigation Plan and PDCO(34 slides)Module 4: Other measures and tools (23 slides)Module_5: CONLUSIONS (16 slides)Test (20 Questions)







Date (yyyy-mm-dd) 2010-05-12 12:45:04








The Design Studio (Discovery of the potential new medicines)



Resource Title The Design Studio (Discovery of the potentialnew medicines)

URL http://thedesignstudio.rsc.org/

Short Description This assignment gives you the opportunity todiscover potential new medicines to treat humandisease. Once you have formed your companyand selected your target disease, you will beable to apply your knowledge of chemistry to thedesign of molecules for testing. Throughout theassignment, you will receive feedback on howyour research programme is doing and you seehow an understanding of molecular interactionsand an appreciation of competitive advantage arecentral to the discovery of new medicines.

Context stand_alone




e-Learning Provider (other) Royal Society of Chemistry (RSC)

Country other

Country (other) UK

Language English

Language (other)

Resource Type multimedia_document practicing_toolself_assessment









http://thedesignstudio.rsc.org/





Registration (details) Contact and Further InformationDr Lorna ThomsonDiscover Chemistry Project OfficerEducation Department, Royal Society ofChemistry, Burlington House, Piccadilly, LondonW1J 0BATel: +44 (0)20 7440 3347

Author(s)


1. Aimed predominantly at post-16 students2. Introduction to diseases and the concepts

of shape, enzyme inhibition, potency, drug-like properties and the balance of propertiesrequired for effective medicines.

3. Students design and test molecules basedon their knowledge of the enzyme active siteand the properties of a range of substituents.They are able to view a 3D molecule modelof their design bound in the enzyme activesite before committing to a round of testing.

4. A competitive advantage bar creates asense of urgency and emphasises theimportance of well-judged analysis, designand hypothesis-testing.

5. At the end of the design round, students aretested in areas directly linked to the A-levelcurriculum - the more questions they getright, the more competitive their researchbecomes.

6. When the student identifies one of thepossible solutions, they can submit theircandidate molecule for clinical development.At this stage, they are faced with the realityof the challenges and costs associated withthe development of new medicines.



Web-portal of RSC. The RSC presents on this pageamong others various scientific games to providea fun and different experience for students.You can download the games, ready to use withyour students.Games:http://www.rsc.org/Education/Teachers/Resources/Games.aspDiscover Molecular Interactions:http://www.rsc.org/Education/DiscoverChemistry/DiscoverMolecularInteractions.aspStart-Up Guide:http://www.rsc.org/images/The%20Design%20Studio%20Start-Up%20Guide_tcm18-173188.pdf

http://www.rsc.org/Education/Teachers/Resources/Games.asp

http://www.rsc.org/Education/Teachers/Resources/Games.asp

http://www.rsc.org/Education/DiscoverChemistry/DiscoverMolecularInteractions.asp

http://www.rsc.org/Education/DiscoverChemistry/DiscoverMolecularInteractions.asp

http://www.rsc.org/images/The%20Design%20Studio%20Start-Up%20Guide_tcm18-173188.pdf





1. The Design Studio introduces the conceptsof shape, enzyme inhibition, potency, drug-likeproperties and the need to achieve a balance ofproperties to discover effective medicines. For16+.2. Discover Molecular InteractionsDevelopment of new medicines is an importantapplication of modern synthetic chemistry.Although the science behind this is complex,Discover Chemistry has developed two interactiveweb-based assignments to allow chemistrystudents at GCSE and A-level to learn what isinvolved in making a medicine. Through theseassignments students and parents alike can learnabout the shape, structure and interactions ofmolecules and what chemical properties arerequired to make effective medicines.





Comments

The Design Studio Start-Up Guide: http://collab.pharmatrain.eu/download/attachments/31326210/The_Design_Studio_Start-Up_Guide.pdf

Posted by nhaider at Feb 09, 2011......................................................................................................................................................................


http://collab.pharmatrain.eu/download/attachments/31326210/The_Design_Studio_Start-Up_Guide.pdf

http://collab.pharmatrain.eu/download/attachments/31326210/The_Design_Studio_Start-Up_Guide.pdf


The Henry Stewart Talks



Resource Title The Henry Stewart Talks

URL http://hstalks.com/main/index_category.php?c=252&

Short Description Another commercial organization who provideson-line seminars rather than formal on-linecourses is The Henry Stewart talks - with asection on biomedical & life sciences informationwhich is of interest to those in drug development. This is a collection of specially prepared animatedaudio visual presentations with synchronizednarration which is regularly updated and growingwith over 1,500 talks.

Context stand_alone


Syllabus Context



Country UK

Country (other)

Language English

Language (other)











Interactivity Level

http://zenosis.com/

http://zenosis.com/




Author(s)


The subjects are varied and not just related topharmaceutical interests. In the Biomedical &Life Science part of the collection there are anumber of categories: Biochemistry, Cancer,Cell Biology, Diseases, Disorders & Treatments,Drug Discovery, Genetics, Immunology, Methods,Microbiology & Virology, Neurobiology andPharmaceutical Science.In the drug development series for exampleare talks on the following subjects (see moreinformation in Annex I) :Advances in Chronic Obstructive PulmonaryDisease (COPD),Antibiotic resistance,Antivirals, Biomarkers,Cancer Pain Management,Cancer Therapy,Chemical Biology,Design and Analysis of Randomised Clinical Trials,Monoclonal Antibodies as Therapeutic Agents,Non-Clinical Testing of Toxicity of Pharmaceuticals,Retroviruses,Stem Cells and Regenerative Medicine,Topical Talks,Tuberculosis,Viruses and Viral Diseases.Elsewhere in their categories (e.g. inPharmaceutical Sciences) talks can be found onthe following subjects:Clinical Proteomics,Good Laboratory Practice (Principle, Complianceand Mutual Recognition),Information to ChemInformatics (DataManagement, manipulation and properties),Microarrays, Pharmaceutical Marketing (Latest insights,challenges, solutions and trends),Respiratory Infection,RNA Interference (Principles and applications),Small Molecule Drug Discovery,SOPs for Regulatory Applications for thePharmaceutical Industry,Stem Cell (recent advances in understanding andutilizing),Stem Cells and Regenerative Medicines(Fundamentals, Therapeutic applications andethical considerations),The world of Hormones (Molecular andphysiological insights)



A collection of external e-Learning resources: fee-base, some free trial talks available


The School of Pharmacy - University of London


The School of Pharmacy - University of London


e-Learning and e-Teaching Demonstration Material



Resource Title e-Learning and e-Teaching DemonstrationMaterial

URL http://elearn.pharmacy.ac.uk/flash/index.htm

Short Description This page contains links to demonstration materialtaken from individual courses and may changeat any time. Some of this material may beexperimental and is shown as an example ofthe methodology not necessarily fully finishedcontent.

Context stand_alone


Syllabus Context


e-Learning Provider (other) Univ. of London

Country other

Country (other) UK

Language English

Language (other)













http://elearn.pharmacy.ac.uk/flash/index.htm



Author(s)


1. Illustrative Teaching Support Material2. Interactive material3. Stand alone Tutorial Material

1. Cells in the stomach - Animatedactive diagram about the physiologyand pharmacology of stomach celltypes and their interactions. http://elearn.pharmacy.ac.uk/flash/view/Stomach_cells.html

2. Release of Insulin - Animated active diagramillustrating release of insulin from pancreaticcells. http://elearn.pharmacy.ac.uk/flash/view/Insulin_release.html

3. Cytochrome P450 Illustration - Animationillustration of the mechanism of cytochromeP450 with the addition of an audiocommentary.

4. Drug absorption and metabolism - Animatedillustration of the central role of the liver inrelation to drug absorption and metabolism.Includes extensive audio commentary.Some animations:

5. http://elearn.pharmacy.ac.uk/flash/view/stom_drugs.html

6. http://elearn.pharmacy.ac.uk/flash/view/peptide%20sequencing.html



Web-based teaching and interactive material.Flash animations.





http://elearn.pharmacy.ac.uk/flash/view/Stomach_cells.html



http://elearn.pharmacy.ac.uk/flash/view/Insulin_release.html

http://elearn.pharmacy.ac.uk/flash/view/Insulin_release.html

http://elearn.pharmacy.ac.uk/flash/view/stom_drugs.html

http://elearn.pharmacy.ac.uk/flash/view/stom_drugs.html

http://elearn.pharmacy.ac.uk/flash/view/peptide%20sequencing.html

http://elearn.pharmacy.ac.uk/flash/view/peptide%20sequencing.html



Thomson Reuter IDRAC Regulatory online learning



Resource Title Thomson Reuter IDRAC Regulatory onlinelearning

URL http://thomsonreuters.com/products_services/science/science_products/a-z/idrac_regulatory_online_learning/

Short Description Thompson Reuters IDRAC Regulatory on-line learning is a commercial organizationwhich also sells modules online courses, whilstmainly the subjects are related to globalregulatory affairs there are also some coverageof some basic information on clinical trials, andPharmacovigilance. These are narrated andinteractive and depending on the modules takearound 1 hour to fully complete.

Context stand_alone


Syllabus Context



Country other

Country (other) USA

Language English

Language (other)











http://zenosis.com/

http://zenosis.com/

http://zenosis.com/


Interactivity Level



Author(s)




A collection of external e-Learning resources: fee-based








UC Television - Health and Medicine


University of California Television - http://www.uctv.tv/health/

http://www.uctv.tv/health/


Pharmacy 102. Breakthrough Medicines



Resource Title Pharmacy 102: Breakthrough Medicines

URL http://www.uctv.tv/search-details.aspx?showID=13010

Short Description Almost every American takes a drug every day;many take three or more. Where have thosebreakthrough medicines come from and how dothey contribute to longevity and quality of life?Join William Soller of UCSF's School of Pharmacyand learn how breakthrough medicines arediscovered. (#13010)First Aired: 9/10/2007



UC Television - Health and Medicine

Syllabus Context 1. Discovery of Medicines


e-Learning Provider (other) UC Television - Health and Medicine

Country other

Country (other) USA

Language English

Language (other)











http://www.uctv.tv/search-details.aspx?showID=13010

http://www.uctv.tv/search-details.aspx?showID=13010





Author(s) R. William Soller


Objective:Share a perspective on discovery use the medicaland pharmaceutical field as a model.Outline:Framework, Surveys, Closer lock at twodiscoveries, concluding implications


75 min


Web-based video lecture. Available also onYouTube http://www.youtube.com/watch?v=SA8io1DYUz0





http://www.youtube.com/watch?v=SA8io1DYUz0

http://www.youtube.com/watch?v=SA8io1DYUz0



Zenosis



Resource Title Zenosis

URL http://zenosis.com/

Short Description Zenosis has a catalogue of modules related todrug development. Their modules which varyin length but are on average 1-2 hours to gothrough at one's own pace (many have no soundassociated so you interact and read through),Regulatory Affairs, Clinical Trials, GMP/CMS, DrugSafety & Pharmacoviglance

Context stand_alone


Syllabus Context



Country UK

Country (other)

Language English

Language (other)











Interactivity Level



http://zenosis.com/


Author(s)




A collection of external e-Learning resources: fee-based








miscellaneous resources


This page list miscellaneous e-learning resources from various sources outside the PharmaTrain project,primarily ordered by topic.


animations


animations, e.g. presentations or visualisations


Drug discovery and development process, Novartis



Resource Title Drug discovery and development process,Novartis

URL http://www.novartis.com/research/drug-discovery.shtml

Short Description Novartis drug discovery and development effortsbegin and end with the patient. R&D efforts areguided by two principles:

• Do we understand the underlying mechanismor cause of the disease?

• Does this disease represent a significantunmet medical need in patients?If the answer to both questions is "yes,"then Novartis develops a research programaimed at better understanding the diseaseand finding an effective therapy.

Context stand_alone




e-Learning Provider (other) Novartis

Country Switzerland

Country (other)

Language English

Language (other)









http://www.novartis.com/research/drug-discovery.shtml

http://www.novartis.com/research/drug-discovery.shtml







Author(s)


Drug discovery and development processDrug discovery - Early development - Fulldevelopment1. Lead optimization2. Hit finding3. Lead Optimization4. Early clinical safety and efficacy5. PoC/Phase I trials6. Phase II trials7. Phase III trials8. Registration9. Pre-launch activities



Web-based flash animation.




Date (yyyy-mm-dd) 2010-05-20; last update:2010-05-20




article-based e-learning


article-based e-learning


In vitro PLOTs in pharmaceutical development



Resource Title In vitro PLOTs in pharmaceuticaldevelopment

URL http://www.sciencedirect.com

Short Description The explosion of genuine high throughputtechnologies has allowed large compound librariesto be screened with ever increasing biologicalspecificity, exacerbating the problem of leadcandidate selection for subsequent drugdevelopment. To avoid creating a bottleneck,compounds identified from the high throughputscreens undergo lead optimisation, a medium-throughput screen which allows ranking in termsof their basic absorption, distribution,metabolism, excretion (ADME) and toxicologicalproperties. The historical role of the preclinicalscientist in the drug discovery/developmentcontinuum has been to perform ADME andtoxicology studies, simply to support theregulatory submission of lead candidates.This situation is, however, changing with thedevelopment of preclinical lead optimisationtechnologies (Approaches to High ThroughputToxicity Screening, London, Atterwill et al., 1999)facilitating the selection of leading candidates,thereby bridging the gap between high throughputefficacy screens and traditional safety assessmentprogrammes. © 2002 Elsevier Science IrelandLtd. All rights reserved.

Context stand_alone


Syllabus Context 1.7 In vitro and in vivo testing of new compounds


e-Learning Provider (other) ScienceDirect, Elsevier B.V.

Country other

Country (other) Netherlands

Language English

Language (other)




http://www.sciencedirect.com












Author(s) Christopher K. Atterwill, Mark G. Wing


In vitro preclinical lead optimisation technologies(PLOTs) in pharmaceutical development1. Introduction2. PLOT in practice3. PLOT technologies4. In silico PLOT5. PLOT and target organ toxicity6. Irritancy, corrosivity, sensitisation andphototoxicity7. Molecular toxicology and PLOT8. Cellular and molecular ''tools'' in regulatorytoxicology9. Hurdles and the way forwardReferences



Web-based article. Article-based e-learning.see also attachment - PDF Version





http://collab.pharmatrain.eu/download/attachments/7372861/In_vitro_PLOTs_in_pharmaceutical_development.pdf



conversation about drug pricing



Resource Title Conversation About Drug Pricing

URL http://www.khanacademy.org/science/healthcare-and-medicine/v/conversation-about-drug-pricing

Short Description A flash video (approx. 13 min) of a recordedinterview with Prof. Lauwrence Baker fromStanford Medical School. Voices combinedwith animated graphics. Topic: drug pricing,reimbursement issues.

Context stand_alone


Syllabus Context 13. Economics of Healthcare


e-Learning Provider (other) KhanAcademy

Country other

Country (other) USA

Language English

Language (other)

Resource Type video_included________




Copyright/Licence (details) freely available



Technical Requirements Flash_Player___

http://www.khanacademy.org/science/healthcare-and-medicine/v/conversation-about-drug-pricing

http://www.khanacademy.org/science/healthcare-and-medicine/v/conversation-about-drug-pricing


___





Registration (details) personal registration is optional (required forposting commentzs/questions), registration ispossible via Google or Facebook account

Author(s)


recorded interview, no strict structure


13:30 min


simple Flash video (voices + animated notes on ablackboard)


quite interesting; reflects the opinion of theinterviewed expert; rather US-centric

Record created by N. Haider





economics of healthcare


13. Economics of Healthcare

• 13.1 Principles of healthcare economics; principles of justice and equity in healthcare economics• 13.2 Principles of pharmacoeconomics• 13.3 Evidence Based Medicine; outcomes research• 13.4 Quality of Life, concept and measurement instruments• 13.5 Principles and practice of marketing; market structure and competition; market analysis,

pricing and reimbursement strategies; national and local formularies• 13.6 Medical marketing and market access• 13.7 Measurement of healthcare efficiency, governmental policy and third party reimbursement• 13.8 Economics of industry: competition, licensing, co-marketing• 13.9 Financial control, return on investment, fixed assets, budgeting, accounting, profitability• 13.10 Generics and biosimilars, parallel imports, OTC; switching strategies• 13.11 Health Technology Assessment (HTA) including meta-analysis and systematic review; health

economics evaluation studies

http://alpha.pch.univie.ac.at/pharmatrain/php/resource_dir.php#


PRINCIPLES OF HEALTH ECONOMICS for non-economists



Resource Title PRINCIPLES_OF_HEALTH_ECONOMICS_for_non-economists

URL http://code.uab.es/xmg/Docencia/Health/HealthEcs.pdf

Short Description Xavier Martinez-Giralt is Professor of Economicsat Universitat Autònoma de Barcelona. Heearned his PhD in Economics in 1988 fromUniversité Catholique de Louvain (CORE).His research interests span both industrialorganization and health economics. In particular,the strategic modeling of providers interaction,the Cost-sharing of Pharmaceutical R&D, hospitalperformance and the private-public mix, andthe diffusion of technology in the health caresector. Presently he is the Director of the Centerfor the Study of Organizations and Decisionsin Economics (CODE), a research center in theUniversitat Autònoma de Barcelona createdin 1995 to promote high quality researchin social choice theory and game theory,industrial organization, financial economics andmacroeconomics.

Context stand_alone




e-Learning Provider (other) Universiat Autònoma de Barcelona, MOVE, CODE

Country Spain

Country (other)

Language English

Language (other)





Copyright/Licence (details) Copyright, 2008 Xavier Martinez-Giralt.Permission is granted to copy, distribute and/ormodify this

http://code.uab.es/xmg/Docencia/Health/HealthEcs.pdf

http://code.uab.es/xmg/Docencia/Health/HealthEcs.pdf


document under the terms of the GNU FreeDocumentationLicense, Version 1.2 or any later version publishedby the FreeSoftware Foundation; with the Invariant Sections,with theFront-Cover Texts, and with the Back-Cover Texts.A copy ofthe license is included in the section entitled "GNUFreeDocumentation License".http://code.uab.es/xmg/



Technical Requirements common_web_browser Adobe_Reader






Author(s) Xavier Martinez-Giralt


HEALTH ECONOMICS1. Economics and Health Economics1.1 What is economics about?1.2 What is health economics? Elements of HE;Organization, actors of the health care market;Structure of a health care system2. The agents of the economy2.1 Demand: consumers, patients, elasticity2.2 Supply: firms, hospitals physicians;Efficiency, Efficacy, Effectiveness, Equity,Opportunity cost2.3 Insurers3. The market and the health care market3.1 Why is the health care market different?3.2 Perfectly competitive markets4. Regulation4.1 The public sector4.2 Mechanisms of regulation4.3 Reasons for regulation4.4 Regulation in the health care market5. Public goods6. Nonprofit organizations6.1 Why do nonprofit enterprises exist?6.2 Modeling a nonprofit hospital7. A health policy exercise8. Uncertainty, risk and insurance8.1 Attitudes facing risk8.2 Health insurance9. Contract theory9.1 Contracts, information and agency relation9.2 Adverse selection, moral hazard and signalling9.3 Supplier induced demand10. Economic evaluation

http://code.uab.es/xmg/


10.1 QALYs10.2 Components in economic evaluation10.3 CEA, CUA, CBA11. Macroeconomics11.1 What is macroeconomics about?11.2 The working of the economy11.3 Macroeconomics of the health sector



PDF document






http://collab.pharmatrain.eu/download/attachments/34734084/PRINCIPLES_OF_HEALTH_ECONOMICS_for_non-economists.pdf



ethics and legal issues


Ethics and Legal Issues


Research Ethics Training Curriculum



Resource Title Research Ethics Training Curriculum

URL http://www.fhi.org/training/en/RETC2/index.html

Short Description Research Ethics Training Curriculum - SecondEdition

Context stand_alone


Syllabus Context 8. Ethics and Legal Issues


e-Learning Provider (other) Family Health International

Country other

Country (other) USA

Language English

Language (other)














Author(s)


Research Ethics Training CurriculumSecond Edition

http://www.fhi.org/training/en/RETC2/index.html


Web Version

• Self-study and Facilitator Group LeadTraining

• Test, evaluation and certification (Flash)Flash Version

• Introduction, slides with notes, case studies,and bibliography (5.6 MB)

• Additional Resources (5.2 MB)• Test, evaluation and certification• This version is for a quick overview of the

curriculumComplete PDF Version

• The curriculum is available as a singledownloadable PDF of 444 pages (4.8 MB)

• Test, evaluation and certification (Flash)• This version is for use by facilitators or

learners who wish to print the wholecurriculum and read it off-line.To receive the Certificate of Completionof this curriculum, you need to pass thetest and answer at least 80% of thequestions correctly. If you fail the test, it willautomatically return you to the first questionto take it again. You can take the test asmany times as you like. If you pass the testsuccessfully, the test will provide you with anevaluation form which you need to completebefore the system issues your certificate.



Web-based online course with multimediaelements and quiz.


Complete PDF Version:

• The curriculum is available as a single PDF of444 pages (4.8 MB)http://collab.pharmatrain.eu/download/attachments/38830112/RETC2_Edition_Full_FNL.pdf



Date (yyyy-mm-dd) 2011-05-19; Last update 2011-05-19


Comments

Complete PDF Version:The curriculum is available as a single PDF of 444 pages (4.8 MB)

http://collab.pharmatrain.eu/download/attachments/38830112/RETC2_Edition_Full_FNL.pdf

Posted by nhaider at May 19, 2011......................................................................................................................................................................







health economics


13. Economics of Healthcare (according to PharmaTrain Syllabus 2010)


The Economics of Health Care - oheschools.org



Resource Title The Economics of Health Care -oheschools.org

URL http://www.oheschools.org/

Short Description An electronic resource, which is an interactivee_source 'The Economics of Health Care'. It isaimed at post-16 students of economic courses,although it contains much that should also be ofinterest to anyone wishing to understand the basicprinciples of health care economics.This e_source represents the third edition.

Context stand_alone


oheschools.org



e-Learning Provider (other) oheschools.org

Country other

Country (other) UK

Language English

Language (other)





Copyright/Licence (details) Office of Health Economics,12 Whitehall,London SW1A 2DYe_mail: [email protected]






http://www.oheschools.org/





Author(s)


The source is split into five units:1. The problems of health care2. The free market approach3. The case against a free market4. Health care in the UK5. Health care - further questionsPDF version



Web-based HTML presentation. Downloadable asPDF document.




Date (yyyy-mm-dd) 2010-05-05 11:56:11


http://collab.pharmatrain.eu/download/attachments/8683526/The_Economics_of_Health_Care_oheschools.pdf



OnlineGCP



Resource Title OnlineGCP

URL http://www.onlinegcp.com/

Short Description OnlineGCP aims towards providing trainingsolutions, which are compliant with globaldirectives but also address some specificlocal requirements and regulations, which areimportant to location-relevant clinical staff.Modifications include language translationand, in some cases, incorporation of specificinformation without taking anything away fromICH guidelines. OnlineGCP currently provide theirtraining solutions in English (UK GCP, US GCP andInternational GCP versions), German GCP, RussianGCP, Spanish GCP, and Polish GCP.

Context stand_alone


Syllabus Context 7. Clinical Trials / 7.4


e-Learning Provider (other) OnlineGCP / Infonetica Research Solutions

Country other

Country (other) UK

Language English

Language (other)

Resource Type multimedia_documentself_assessmenteTest_examination


SCORM Package available no


Copyright/Licence (details) commercial course



Technical Requirements common_web_browserAdobe_ReaderFlash_Player

http://www.onlinegcp.com/






Registration (details) http://www.gcptraining.org.uk/default.aspx?page=purchaseoptions

Author(s) Dr Isaac John, Assistant Director of Research andDevelopment at Ashford and St Peter's HospitalsNHS Trust


1. Introduction & The Principles of ICH GCP1.1 Background1.2 Structure of ICH1.3 ICH Administration1.4 The ICH Process for Harmonisation ofGuidelines1.5 Revised ICH Terms of Reference1.6 The Principles of ICH-GCP1.7 Conditions and Principles which apply to allClinical TrialsIntroduction Key Learning Points2. Informed Consent2.1 Definition of Informed Consent2.2 Capable Adults2.3 Informing the Patient2.4 Informed consent - requirements2.5 Principles of the EU Directive for Inclusion ofMinors & Incapable Adults in Clinical Trials2.6 Definition of a Legal Representative2.7 Definition of a Minor2.8 Definition of an Incapable Adult2.9 Responsibilities of Ethics Committees in Trialsinvolving Minors or Incapable Adults2.10 The Human Tissue Act 20042.11 Who can give Appropriate Consent?2.12 Exceptions to Consent2.13 Offences and Penalties2.14 Mental Capacity Act 2005Annex AAnnex BCase StudyInformed Consent: Key Learning Points3. EthicsIRAS: Integrated Research Application System3.1 Responsibilities3.2 Composition, Functions and Operations3.3 Procedures3.4 Records3.5 Information sharingEthics: Key Learning Points4. Investigator ResponsibilitiesResponsibilities of Chief Investigator / PrincipalInvestigator4.1 Investigator's Qualifications and Agreements4.2 Adequate Resources4.3 Medical care of Trial Subjects4.4 Communication with IRB/IEC

http://www.gcptraining.org.uk/default.aspx?page=purchaseoptions

http://www.gcptraining.org.uk/default.aspx?page=purchaseoptions


4.5 Compliance with Protocol4.6 Investigational Products4.7 Randomisation Procedures and Unblinding4.8 Informed Consent of Trial Subjects4.9 Records and Reports4.10 Progress Reports4.11 Safety Reporting4.12 Premature Termination or Suspension of aTrial4.13 Final ReportsCase StudyInvestigator Responsibilities: Key Learning Points5. Sponsor ResponsibilitiesSponsorSponsor Responsibilities / Functions5.1 Quality Assurance and Quality Control:5.2 Contract Research Organisation (CRO)5.3 Medical Expertise5.4 Trial Design5.5 Trial Management, Data Handling, and RecordKeeping5.6 Investigator Selection5.7 Allocation of Responsibilities5.8 Compensation to Subjects and Investigators5.9 Financing5.10 Notification / Submission to RegulatoryAuthorities5.11 Confirmation of Review by IRB/IEC5.12 Information on Investigational Products5.13 Manufacturing, Packaging, Labelling, andCoding Investigational Products5.14 Supplying and Handling InvestigationalProducts5.15 Record Access5.16 Safety Information5.17 Adverse Drug Reaction Reporting5.18 Monitoring5.18 Monitoring (continued)5.19 Audit5.20 Non-compliance5.21 Premature Termination or Suspension of aTrial5.22 Clinical Trial / Study Reports5.23 Notification of Serious Breaches5.24 Multi-centre Trials5.25 Infringement Notices and OffencesCase StudySponsor Responsibilities: Key Learning Points6. Clinical Trial Protocol6.1 General Information6.2 Background Information6.3 Trial Objectives and Purpose6.4 Trial Design6.5 Selection and Withdrawal of Subjects6.6 Treatment of Subject6.7 Assessment of Efficacy6.8 Assessment of Safety6.9 Statistics6.10 Direct Access to Source Data/Documents6.11 Quality Control and Quality Assurance6.12 Ethics6.13 Data Handling and Record Keeping6.14 Financing and Insurance6.15 Publication Policy


6.16 SupplementsClinical Trial Protocol and Protocol Amendments:Key Learning Points7. Investigator Brochure7.1 General Considerations7.2 Contents of the Investigators Brochure7.2 Contents of the Investigators Brochure -ContinuedAppendix-1Appendix-2Investigator Brochure: Key Learning Points8. Essential Documents8.1 Introduction8.1.1 Recommended Archiving8.1.2 Trial Master File Archiving8.1.3 How to Archive?8.1.4 Filing of Source Documents8.1.5 Additional Recommended Documentation:8.2 Before the Clinical Phase of the TrialCommences8.3 During the Clinical Conduct of the Trial8.4 After Completion or Termination of the TrialAppendix-1Case StudyEssential Documents: Key Learning Points9. Safety Reporting9.1 Investigators Responsibilities9.2 Sponsors Responsibilities9.3 Recording and Evaluation of Adverse Events(AEs)9.3.1 Assessment of Seriousness9.3.2 Assessment of Causality9.3.3 Assessment of Expectedness9.4 Reporting of Serious Adverse Reactions(SARs)9.5 Adverse reactions/Events in Blinded Trials9.6 Adverse Reactions/Events in Trials with HighMorbidity and High Mortality Diseases9.7 Annual Safety Reports9.8 Reporting Time Frame for Annual SafetyReport9.9 How to Inform Investigators?9.10 Reporting of Safety Issues FollowingCompletion of the Clinical Trial in ECase StudySafety Reporting: Key Learning Points


approx. 1 hour per chapter (9 chapters)


The design is classical: a lot of text, almost nographical elements, there is a possibility to opensome definitions of keywords (context-sensitivehelp).


The content and structure of the course arevalid, it contains a few basic cases. There is a 30questions quiz at the end.

Record created by N. Haider, J.-M. Boeynaems





Pharmaceutical Research and Development. ADescription and Analysis of the Process, 2001



Resource Title Pharmaceutical Research and Development:A Description and Analysis of the Process

URL http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL30913.pdf

Short Description A central element of the debate about inclusionof prescription drug benefits in Medicare is theprice of prescription drugs. A key issue in thedebate concerns the relationship between thoseprices and the pharmaceutical research anddevelopment (R&D) costs. While this reportwill not analyze that relationship directly, itdoes present a description and assessment ofthe pharmaceutical R&D (drug development)process and the factors that affect costs. Such ananalysis should be useful in addressing questionsabout the cost of pharmaceutical R&D and thedependence of prescription drug prices in theUnited States on those costs.Pharmaceutical R&D (drug development) consistsof several stages. It begins with drug discoveryfollowed by preclinical drug development wherethousands of candidate chemicals maybe screenedfor attractive therapeutic, pharmacological, andtoxicity properties. Successful candidates are thensubjected to three stages of clinical trials testingthe drugs' effectiveness and side effects. If a drugemerges from the trials showing a significanttherapeutic benefit, it is submitted to the Foodand Drug Administration for marketing approval.If approved, post-marketing surveillance ensueslooking for possible safety concerns that did notemerge in the earlier trials.

Context stand_alone




e-Learning Provider (other) Congressional Research Service

Country other

Country (other) USA

Language English

Language (other)


http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL30913.pdf

http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL30913.pdf








Technical Requirements common_web_browser JavaScript Adobe_Reader






Author(s)


ContentsIntroductionBackgroundBiological Basis of DiseaseBasics of PharmaceuticalsThe Research ProcessOverviewDrug DiscoveryPreclinical TestingClinical TrialsDescriptionGeneral FeaturesDiscussionDevelopment TimeR&D CostsCongressional ConcernsDrug Development CostsFederal Biomedical R&D FundingClinical Trial PracticeConclusionsAppendix AA Brief History of Pharmaceutical Research andDevelopment



Web-based PDF document.Local copy: http://collab.pharmatrain.eu/download/attachments/19038210/PharmResearchAndDevelopment_2001.pdf



http://collab.pharmatrain.eu/download/attachments/19038210/PharmResearchAndDevelopment_2001.pdf





Date (yyyy-mm-dd) 2010-09-01 11:34:23




pharmacokinetics


Pharmacokinetics


A First Course in Pharmacokinetics and Biopharmaceutics, OUHSC College ofPharmacy



Resource Title A First Course in Pharmacokinetics andBiopharmaceutics, OUHSC College ofPharmacy

URL http://www.boomer.org/c/p1/

Short Description Course OutlinePharmaceutics III - Pharmacokinetics andBiopharmaceuticsLecturer: Dr David BourneLectures: One semester - Three hours per weekLaboratory: One semester - One (three hour)session per week

Context stand_alone


Syllabus Context


e-Learning Provider (other) OUHSC College of Pharmacy

Country other

Country (other) USA

Language English

Language (other)

Resource Type multimedia_documentself_assessment




Copyright/Licence (details) Course on CD (http://www.boomer.org/CDinfo.html):A single user copy of this CD is $US20 by checkmade out to 'OU College of Pharmacy' sent to:David BourneOUHSC College of Pharmacy1110 N. Stonewall Ave, Oklahoma City, OK 73117U.S.A.


Delivery Mode (other) course on CD

http://www.boomer.org/c/p1/

http://www.boomer.org/CDinfo.html

http://www.boomer.org/CDinfo.html


Technical Requirements common_web_browserJavaScriptJava





Registration (details) David BourneOUHSC College of Pharmacy1110 N. Stonewall Ave, Oklahoma City, OK 73117U.S.A.

Author(s) David Bourne


1. Introduction to Course2. Background Material3. Pharmacokinetic Introduction4. One Compartment I.V. Bolus5. Analysis of Urine Data6. Intravenous Infusion7. Routes of Drug Administration8. Pharmacokinetics of Oral Administration9. Calculation of Bioavailability Parameters10. Bioavailability Studies11. Physiological Factors Affecting Oral Absorption12. Physical-Chemical Factors Affecting Oral13. Formulation Factors14. Multiple IV Bolus Dose Administration15. Multiple Oral Dose Administration16. Routes of Excretion17. Metabolism18. Drug Distribution19. Multi-Compartment Pharmacokinetic Models20. Non-Linear Pharmacokinetic Models21. Clinical Applications of Pharmacokinetics22. Laboratory AssignmentsJava Applets - On line GraphsJavaScript Calculators Online







http://www.boomer.org/c/p1/pa_index.html

http://www.boomer.org/c/p1/jscalc_index.html



boomer_org



Resource Title boomer_org

URL http://www.boomer.org/pkin/

Short Description Pharmacokinetic and Pharmacodynamic ResourcesThe purpose of this page is to providelinks to information about the discipline ofPharmacokinetics and Pharmacodynamics.

Context stand_alone


Syllabus Context 9. Data Management and Statistics


e-Learning Provider (other) boomer_org

Country other

Country (other) USA

Language English

Language (other)














Author(s)

http://www.boomer.org/pkin/



On-line Courses

• A First Course in Pharmacokinetics andBiopharmaceutics by David Bourne

• Pharmacokinetics - Biopharmaceutics byDavid Bourne

• Interactive Clinical Pharmacology using Flashby Dr Matt Doogue, Christchurch Hospital

• An online course in Basic Pharmacokineticsby Makoid, M.C., Vuchetich, P.J., andBanakar, U.V.

• Principles of Drug Disposition at University ofIowa by Craig K. Svensson et al.

• USC Laboratory of Applied Pharmacokinetics(Roger Jelliffe)

• Web Based Pharmacometrics LearningResource provided by the American Collegeof Clinical Pharmacology and the FDA



Web site with Pharmacokinetic andPharmacodynamic Resources







Pharmacokinetics and Biopharmaceutics, Univ. of Iowa



Resource Title Pharmacokinetics and Biopharmaceutics,Univ. of Iowa

URL http://www.uiowa.edu/~c046138/KINETICS_HOMEPAGE.htm

Short Description Pharmacokinetics and Biopharmaceutics (46:138)is a required course in the P-2 year of the Doctorof Pharmacy Program at The University of Iowa.These pages provide supplemental material forthe lectures given by Dr. Craig Svensson.Brief course description:Qualitative and quantitative description of kineticsof drug absorption, distribution, and elimination,including physiological factors that influenceeach process; adjustment of dosing regimens foroptimizing therapeutic drug levels in the body.

Context stand_alone


Syllabus Context


e-Learning Provider (other) Univ. of Iowa

Country other

Country (other) USA

Language English

Language (other)

Resource Type multimedia_documentself_assessment








http://www.uiowa.edu/~c046138/KINETICS_HOMEPAGE.htm

http://www.uiowa.edu/~c046138/KINETICS_HOMEPAGE.htm






Registration (details) Craig K. Svensson, Pharm.D., Ph.D.Division of PharmaceuticsThe University of IowaIowa City, IA 52242(319) 335-8823Email: [email protected]

Author(s) Craig K. Svensson


Learning objectives:1. Determinants of Pharmacologic Effect2. Passage of Xenobiotics Across BiologicalMembranes3. Effect of Route of Administration on DrugDisposition and Action4. Distribution of Xenobiotics5. Routes of Elimination of Xenobiotics6. Pharmacogenetics7. Noncompartmental Pharmacokinetics8. Hepatic Clearance9. Metabolite Kinetics10. Pharmacokinetic Drug Interactions11. Dose- and Time-Dependent Pharmacokinetics12. Stereochemistry Considerations inPharmacokinetics









Pharmacokinetics - Pharmaceutics - Biopharmaceutics



Resource Title Pharmacokinetics - Pharmaceutics -Biopharmaceutics

URL http://dir.pharmacy.dal.ca/kinetic.php

Short Description Drug Information Resources

Context stand_alone


Syllabus Context


e-Learning Provider (other) Dalhousie University, College of Pharmacy

Country other

Country (other) USA

Language English

Language (other)














Author(s)

http://dir.pharmacy.dal.ca/kinetic.php



1. Basic Pharmacokinetics2. Therapeutic Drug Monitoring3. Pharmacokinetics in Drug Monographs



Collection of links: websites, software, journals







Rx Kinetics



Resource Title Rx Kinetics

URL http://www.rxkinetics.com/

Short Description Software solutions for pharmacists

Context stand_alone


Syllabus Context


e-Learning Provider (other) RxKinetics

Country other

Country (other) USA

Language English

Language (other)









Technical Requirements (other) e.g. Palm OS




Registration (details) E-Mail:[email protected]:RxKinetics1103 S. Oak St.Plattsburg, MO 64477

http://www.rxkinetics.com/


USAFax:+1-801-740-5025

Author(s)


1. Antibiotic Kinetics2. APK3. DripCharts4. Kinetics5. TPNassist6. UD Labels



Web site: software solutions for pharmacists







pharmacology


pharmacology


Basics of pharmacology, Univ. of Vienna



Resource Title Basics of pharmacology, Univ. of Vienna

URL http://www.univie.ac.at/ptox/eLearning/main.html

Short Description The eLerning platform of the Department ofPharmacology and Toxicology. The courseis part of the teaching program in "GeneralPharmacology". It illustrates the principles ofreceptor functon, pharmacokinetics and how ionchannels work.

Context stand_alone


Syllabus Context


e-Learning Provider (other) Univ. of Vienna

Country other

Country (other) Austria

Language English

Language (other)

Resource Type multimedia_documentpracticing_toolself_assessment








Technical Requirements (other) IE



http://www.univie.ac.at/ptox/eLearning/main.html

http://www.univie.ac.at/ptox/eLearning/main.html




Author(s) Eugen Timin, Stanislav Beyl, Steffen Hering.


1. Pharmacodynamics1.1 Law of mass action1.2 Dose occupancy curve1.3 Dose occupancy curve (task)1.4 Competetive antagonism1.5 Competetive antagonism (dose responsecurves)1.6 Non-competetive antagonism1.7 Efficacy1.8 Full agonist in the presence of partial agonist1.9 Partial agonist in the presence of full agonist1.10 Interaction of drugs (task)1.11 Beta-blocker (task)1.12 Receptor down regulation1.13 Spare receptors2. Pharmacokinetics2.1 Single compartment model2.2 First-pass (presystemic) metabolism2.3 Two compartment model2.4 Continuous infusion2.5 Continuous infusion (task)2.6 Multiple drug administration2.7 Intravenous & oral administration2.8 Intravenous & oral administration (task)2.9 Enzyme induction2.10 Interruption of drug administration2.11 Therapeutic range of drug action2.12 Beta-Phase3. Ion channel simulations3.1 Use-dependent ion channel block3.2 Calcium channel gating3.3 HERG channel gating3.4 HERG channel gating II4. Basic knowlege for pharmacologists4.1 Ligand-gated channel I4.2 Ligand-gated channel II4.3 Ligand-gated channel III4.4 NMDA channel4.5 Voltage-gated channel block



Flash designed illustrations, self-testinganimations and games.







Recommendations on Clinical Research - JAPhMed



Resource Title Recommendations on Clinical Research -JAPhMed

URL http://japhmed.jp/english/whats_new/recommendations_on_clinical_research.html

Short Description Japanese Association of Pharmaceutical Medicine:Japanese clinical research has been on the declinein recent years, in spite of the policy adopted inthe Ethics Guideline for Clinical Studies of 2009implemented by the Ministry of Health, LabourandWelfare of Japan which states the following: "Withthe advances in science and technology, clinicalresearch has become increasingly important.Even the methods that have been established asoptimalfor the prevention, diagnosis, or treatmentof diseases need to be continuously reviewedand revalidated in clinical research in order toreconfirm their efficacy, efficiency, convenience,and quality". Japan's international ranking in thenumber of academic papers published has beenfalling since 2003: Japan is currently in the 18thposition. The lack of high-quality clinical researchand thelag in data generation or evidence-building fromclinical research findings are issues that need tobe promptly addressed for the benefit of higherstandards in healthcare to our citizens.

Context stand_alone


Syllabus Context


e-Learning Provider (other) JAPhMed

Country other

Country (other) Japan

Language English

Language (other)




http://japhmed.jp/english/whats_new/recommendations_on_clinical_research.html

http://japhmed.jp/english/whats_new/recommendations_on_clinical_research.html






Technical Requirements common_web_browserAdobe_Reader






Author(s)


Contents1. Background(1) Gap in International Evaluation(2) Clinical Research Required for Improvement ofHealthcare(3) Necessity of Investigator-Led Clinical Research(4) Technical Stimulation/Promotion of SupportFramework(5) Promoting Awareness2. The State of Clinical Studies and FutureChallenges(1) Human Resources and Organizations(2) Process(3) Strategies and Outcomes3. Possible Solutions(1) Altering the Mindset of Healthcare Institutionsand Creating /Improving Clinical ResearchOrganizations(2) Enhancement of Clinical ResearchOrganizations(3) Training Doctors and Other Human ResourcesInvolved in Clinical Research(4) The Funding Issue(5) Financial Support from PharmaceuticalCompaniesPDF document



PDF document.




http://collab.pharmatrain.eu/download/attachments/8814594/JAPhMed_Recommendations_on_Clinical_Research.pdf


Date (yyyy-mm-dd) 2010-05-06 11:43:10




SMi Source



Resource Title SMi Source

URL http://www.sciencelearningsource.com/sls/hub

Short Description A multimedia resource for medical and scientificlearning. It can be used for learning or preparingpresentations. It is composed of numerous shorttopics that can be grouped in lessons.

Context stand_alone


Syllabus Context


e-Learning Provider (other) ScienceMedia

Country other

Country (other) USA

Language English

Language (other)














http://www.sciencelearningsource.com/sls/hub


Author(s)


SMi Source contains a wide range of multimediasequences in many fields of biomedicine. They areavailable as individual topics, that can be groupedin lessons. Several of them are related to drugdevelopment. Hereafter a few examples : * Introduction: biologics (21 min) * What is biotechnology (9 min) * Drug discovery : target validation (2 min) * Drug discovery : biomarkers 1 min) * Clinical trial design (30 min) * Use of statistics in clinical trials (33 min) * Diabetes : introduction to clinical trial design(63 min)...There are not less than 332 topics related toclinical trials and 180 to pharmacokinetics. A widerange of therapeutic areas is covered.




The search of an adequate resource is madesomewhat difficult by the multiplicity of shorttopics and their inclusion in broader modules,which creates redundancy.

Record created by J.-M. Boeynaems & N. Haider





statistics


statistics


creascience_com



Resource Title creascience_com

URL http://training.creascience.com/

Short Description Creascience's website dedicated to appliedtraining sessions in statistics. The public trainingsessions catalog, a wealth of practical information,and the available training options are available onthis site.

Context stand_alone




e-Learning Provider (other) creascience.com

Country other

Country (other) Canada

Language English

Language (other)














http://training.creascience.com/


Author(s)


1. Multivariate Data Analysis School2. Cluster Analysis and its Applications3. Efficient Design and Analysis of Shelf-Life &Stability Studies4. Introduction to the Design of Experiments(DOE)5. Principal Component Analysis and itsApplications6. Data Modeling Workshop 05-10-20097. Preference Mapping in Practice8. Advanced Experimental Designsetc.



Website, list of non-free courses on statistics







davidmlane_com



Resource Title davidmlane_com

URL http://davidmlane.com/hyperstat/

Short Description HyperStat Online Statistics Textbook

Context stand_alone




e-Learning Provider (other) davidmlane_com

Country other

Country (other) USA

Language English

Language (other)














Author(s)


1. Introduction to Statistics2. Describing Univariate Data

http://davidmlane.com/hyperstat/


3. Describing Bivariate Data4. Introduction to Probability (elementary)5. Normal Distribution6. Sampling Distributions7. Point Estimation8. Confidence Intervals9. The Logic of Hypothesis Testing10. Testing Hypotheses with Standard Errors11. Power12. Introduction to Between-Subjects ANOVA13. Factorial Between-Subjects ANOVA14. Within-Subjects/Repeated Measures ANOVA15. Prediction16. Chi Square17. Distribution-Free Tests18. Measuring Effect Size



Web site devoted to statistics







Online Statistics - An Interactive Multimedia Course of Study



Resource Title Online Statistics: An Interactive MultimediaCourse of Study

URL http://onlinestatbook.com/

Short Description Online Statistics: A Multimedia Course of Study isan introductory-level statistics book. The materialis presented both as a standard textbook and asa multimedia presentation. The book featuresinteractive demonstrations and simulations, casestudies, and an analysis lab.

Context stand_alone




e-Learning Provider (other) onlinestatbook.com

Country other

Country (other) USA

Language English

Language (other)

Resource Type multimedia_documentaudio_includedpracticing_toolself_assessment




Copyright/Licence (details) This work is in the public domain. Therefore, itcan be copied and reproduced without limitation.Authors would appreciate a citation wherepossible.



Technical Requirements common_web_browserJavaScriptJava

Technical Requirements (other) QuickTime

http://onlinestatbook.com/





Registration (details) The site was developed at Rice University,University of Houston, Clear Lake, and Universityof Houston, DowntownContact person: David Lane, [email protected] Page: http://www.ruf.rice.edu/~lane/

Author(s) David Lane, Joan Lu, Camille Peres, Emily Zitek(major contributors)


1. Introduction2. Graphing Distributions3. Summarizing Distributions4. Describing Bivariate Data5. Probability6. Normal Distributions7. Sampling Distributions8. Estimation9. Logic of Hypothesis Testing10. Testing Means11. Power12. Prediction13. ANOVA14. Chi Square15. Case Studies16. Calculators17. GlossarySimulations and Demonstrations



The simulations and self-test programs requireJava.





http://www.ruf.rice.edu/~lane/



statistics_com



Resource Title statistics_com

URL http://www.statistics.com/

Short Description Statistics.com is the leading provider ofprofessional development courses in statistics.Online programs give you regular access toleading experts in statistics with courses that fityour budget and schedule. Enroll in a Programin Advanced Statistical Study (PASS) to earn acertificate (biostatistics, environmental statistics,data mining, etc.), or just register in specificcourses as desired.

Context stand_alone




e-Learning Provider (other) statistics.com

Country other

Country (other) USA

Language English

Language (other)












http://www.statistics.com/



Registration (details) statistics.com612 N. Jackson St.Arlington, VA 22201USA(703) 522-5410Fax: (703) 522-5846

Author(s)


UPCOMING COURSES

• Introduction to Statistics 3 - ANOVA andMultiple Regression (August 06)

• Maximum Likelihood Estimation (August 06)• Biostatistics 1 (August 06)• Introduction to Statistics 1: Inference for a

Single Variable (August 06)• Survey Analysis (August 13)• Matrix Algebra Review (August 13)• Practical Rasch Measurement - Core Topics

(August 20)• Introduction to Bayesian Statistics (August

20)• Modeling in R (August 20)• SAS® - Basics (August 27)• Clinical Trials Statistics -Bioavailability and

Bioequivalence (August 27)• Nonparametric Statistics (August 27)• Introduction to Statistics 2: Working with

Bivariate Data (September 03)• Epi 2: Bias in Epidemiologic Studies

(September 03)• Introduction to Statistics for Beginners

(September 03)FEATURED COURSEClinical Trials - BioavailabilityThis course covers the topics ofbioequivalence and dose-response modeling,and provides practical work with actual/simulated clinical trial data.



Web site, List of non-free courses on statistics







StatSoft Electronic Statistics Textbook



Resource Title StatSoft Electronic Statistics Textbook

URL http://www.statsoft.com/textbook/

Short Description This Electronic Statistics Textbook offerstraining in the understanding and applicationof statistics. The material was developed atthe StatSoft R&D department based on manyyears of teaching undergraduate and graduatestatistics courses and covers a wide varietyof applications, including laboratory research(biomedical, agricultural, etc.), business statisticsand forecasting, social science statistics andsurvey research, data mining, engineering andquality control applications, and many others.The Electronic Textbook begins with an overviewof the relevant elementary (pivotal) conceptsand continues with a more in depth explorationof specific areas of statistics, organized by"modules," accessible by buttons, representingclasses of analytic techniques. A glossary ofstatistical terms and a list of references for furtherstudy are included.Proper citation(Electronic Version): StatSoft, Inc. (2010).Electronic Statistics Textbook. Tulsa, OK: StatSoft.WEB: http://www.statsoft.com/textbook/.(Printed Version): Hill, T. & Lewicki, P. (2007).STATISTICS Methods and Applications. StatSoft,Tulsa, OK.

Context stand_alone




e-Learning Provider (other) StatSoft, Inc.

Country other

Country (other) USA

Language English

Language (other)




http://www.statsoft.com/textbook/

http://www.statsoft.com/textbook/












Author(s) T. Hill, P. Lewicki, StatSoft, Inc.


1. Elementary Concepts in Statistics2. Basic Statistics3. ANOVA/MANOVA4. Association Rules5. Boosting Trees for Regression and Classification6. Canonical Analysis7. CHAID Analysis8. Classification and Regression Trees9. Cluster Analysis10. Correspondence Analysis11. Data Mining Techniques12. Discriminant Function Analysis13. Distribution Fitting14. Experimental Design (Industrial DOE)15. Principal Components and Factor Analysis16. General Discriminant Analysis (GDA)17. General Linear Models (GLM)18. Generalized Additive Models (GAM)19. Generalized Linear Models (GLZ)20. General Regression Models (GRM)21. Selected Topics in Graphical AnalyticTechniques22. Independent Components Analysis23. Multiple Regression24. Log-Linear Analysis of Frequency Tables25. Multivariate Adaptive Regression Splines(MARSplines)26. Machine Learning27. Multidimensional Scaling28. Neural Networks29. Nonlinear Estimation30. Nonparametric Statistics31. Partial Least Squares (PLS)32. Power Analysis33. Process Analysis34. Quality Control Charts35. Reliability and Item Analysis36. Structural Equation Modeling37. Survival/Failure Time Analysis


38. Text Mining39. Time Series Analysis40. Variance Components and Mixed ModelANOVA/ANCOVA41. Statistics Glossary42. Statistical Advisor43. Distribution Tables44. REFERENCES CITED



Menu-driven HTML presentation.







translational medicine


translational medicine


Biomedical informatics and translational medicine



Resource Title Biomedical informatics and translationalmedicine

URL http://www.translational-medicine.com/content/8/1/22

Short Description Biomedical informatics involves a core set ofmethodologies that can provide a foundation forcrossing the "translational barriers" associatedwith translational medicine. To this end, thefundamental aspects of biomedical informatics(e.g., bioinformatics, imaging informatics, clinicalinformatics, and public health informatics) maybe essential in helping improve the ability to bringbasic research findings to the bedside, evaluatethe efficacy of interventions across communities,and enable the assessment of the eventual impactof translational medicine innovations on healthpolicies. Here, a brief description is providedfor a selection of key biomedical informaticstopics (Decision Support, Natural LanguageProcessing, Standards, Information Retrieval, andElectronic Health Records) and their relevanceto translational medicine. Based on contributionsand advancements in each of these topic areas,the article proposes that biomedical informaticspractitioners ("biomedical informaticians") canbe essential members of translational medicineteams.

Context stand_alone


Syllabus Context 1.8 Principles of translational medicine


e-Learning Provider (other) Journal of Translational Medicine

Country other

Country (other) USA

Language English

Language (other)





http://www.translational-medicine.com/content/8/1/22












Author(s) Indra Neil Sarkar


1. Biomedical Informatics2. Decision Support3. Natural Language Processing4. Standards5. Information Retrieval6. Electronic Health Records7. The Role of the Biomedical Informatician in aTranslational Medicine Team8. Conclusion9. References



Web-based open access article. Article-basedlearning.see also attachment - PDF-version





http://collab.pharmatrain.eu/download/attachments/7372855/Biomedical_informatics_and_translational_medicine.pdf



Translational Medicine - doing it backwards



Resource Title Translational Medicine - doing it backwards

URL http://www.translational-medicine.com/content/8/1/12

Short Description In recent years the concept of "translationalmedicine" has been advanced in an attemptto catalyze the medical applications of basicbiomedical research. However, there has beenlittle discussion about the readiness of scientiststhemselves to respond to what we believe is arequired new approach to scientific discoveryif this new concept is to bear fruit. The presentparadigm of hypothesis-driven research poorlysuits the needs of biomedical research unlessefforts are spent in identifying clinically relevanthypotheses. The dominant funding system favorshypotheses born from model systems and nothumans, bypassing the Baconian principle ofrelevant observations and experimentationbefore hypotheses. Here, we argue that that thisattitude has born two unfortunate results: lack ofsufficient rigor in selecting hypotheses relevantto human disease and limitations of most clinicalstudies to certain outcome parameters rather thanexpanding knowledge of human pathophysiology;an illogical approach to translational medicine.If we wish to remain true to our responsibilityand duty of performing research relevant tohuman disease, we must begin to think aboutfundamental new approaches.

Context stand_alone


Syllabus Context 1.8 Principles of translational medicine


e-Learning Provider (other) Journal of Translational Medicine

Country other

Country (other) USA

Language English

Language (other)

















Author(s) Robert B Nussenblattl, Francesco M Marincola,Alan N Schechter


The concept of "translational medicine".



Web-based article. Article-based learning.see also attachment - PDF-version





http://collab.pharmatrain.eu/download/attachments/7372857/Translational_Medicine-doing_it_backwards.pdf



video-based e-learning


video-based e-learning and news

LabTube: Drug Research

http://www.labtube.tv/avc-interest.aspx?i=3&c=1


LabTube - Drug Research



Resource Title LabTube - Drug Research

URL http://www.labtube.tv/avc-interest.aspx?i=3&c=1

Short Description LabTubeNews March 2010A selection of this months news articles fromthe life science industry including new productlaunches, company mergers and conferencereviews.LabTubeNews.tvPublished : 2010/03/31

Context stand_alone


Syllabus Context


e-Learning Provider (other) LabTubeNews.tv

Country other

Country (other) UK

Language English

Language (other)


Resource Type (other) tv







Technical Requirements (other) Microsoft Silverlight




http://www.labtube.tv/avc-interest.aspx?i=3&c=1



Author(s)


Drug research - Lectures1.Stem Cell Clinic Publishes First Peer ReviewedPaper on Autism Stem Cell TherapySAN DIEGO-The Institute for Cellular Medicine(www.cellmedicine.com) announced today whatappears to be the first publication in a peerreviewed journal outlining scientific rationale forthe use of stem cells in the treatment of autism.Published : 2007/07/11http://www.labtube.tv/avc-interest.aspx?i=5&c=1&v=1902. Unproven drugs, desperate patientsRonald Krall, chief medical officer ofGlaxoSmithKline, chairs GSK's Global SafetyBoard and has responsibility for monitoring thesafety of GSK medicines, managing regulatoryaffairs, and dealing with policy questionsrelated to R&D. A neurologist by training, hehas led drug-development programs in varioustherapeutic areas during his more than twodecades in the pharmaceutical industry.Published : 2007/11/07http://www.labtube.tv/avc-interest.aspx?i=5&c=1&v=132



Web-based tv, videos: lectures and news.





http://www.labtube.tv/avc-interest.aspx?i=5&c=1&v=190





Name: Key: GA Available Pages H. Directory of e-Learning ... · • Coursera • EdX • FDA •...

Documents

Transcript of Name: Key: GA Available Pages H. Directory of e-Learning ... · • Coursera • EdX • FDA •...