Welcome to the Open Day! NUSAGE - PAREXEL Postgraduate ... NUSAGE-PAREXEL PG Certificate...
40
1 Welcome to the Open Day! Welcome to the Open Day! NUSAGE - PAREXEL Postgraduate Certificate Postgraduate Certificate in Good Clinical Practice H id B h PhD Heidrun Bruchmann, PhD Director, PAREXEL Academy 11/30/2011 © 2010 PAREXEL International | Confidential
Transcript of Welcome to the Open Day! NUSAGE - PAREXEL Postgraduate ... NUSAGE-PAREXEL PG Certificate...
1
Welcome to the Open Day!Welcome to the Open Day!
NUSAGE - PAREXELPostgraduate Certificate Postgraduate Certificate in Good Clinical Practice
H id B h PhDHeidrun Bruchmann, PhDDirector, PAREXEL Academy
11/30/2011
© 2010 PAREXEL International | Confidential
2
Who we are
Dr Heidrun Bruchmann Director
Valerie Howarth-Gruender Course Coordinator
Lecturers:
Dr Matthias Grossmann The Drug Development Process
Bettina Merz-Nideroest/ Regulatory AffairsD Ed d LDr Edmund Leong
Claudia Richter Conducting Clinical Research
Dr Sabine Brunschoen-Harti Client Relationship Management
11/30/2011
3
Topics
1. PAREXEL International2. PAREXEL Academy2. PAREXEL Academy3. Course Structure 4. Selection of Students5. Module 1: The Drug Development Process5. Module 1: The Drug Development Process6. Module 2: Regulatory Affairs7. Module 3: Conducting Clinical Research8 Module 4: Client Relationship Management8. Module 4: Client Relationship Management9. Assessments/Marking System10. Work Placement11 Career Opportunities11. Career Opportunities12. Questions?
11/30/2011
4
PAREXEL International
Ukraine (2)
PAREXEL has more than 10,850 employees worldwide
Belgium France (2) Netherlands
United States (17)
Ukraine (2)United Kingdom (6)
United States (17)
BelgiumCroatiaCzech RepublicDenmarkFinland
France (2)Germany (3)HungaryItalyLithuania
NetherlandsPolandRomaniaRussia (2)Spain
Israel
( )California
ConnecticutIllinois
MarylandMassachusetts
New Jersey China (4)Israel
CaliforniaConnecticut
IllinoisMaryland
MassachusettsNew Jersey China (4)
Mexico
Japan (3)Israel
India (2)
New JerseyNorth Carolina
PennsylvaniaVirginia
Hong KongIndonesiaS. KoreaMalaysiaPhilippinesSingaporeArgentina
IsraelNorth Carolina
PennsylvaniaVirginia
Hong KongIndonesiaS. KoreaMalaysiaPhilippinesSingaporeArgentina
South Africa (3)
g pTaiwanThailand
Australia
gBrazil ChilePeru
South Africa (3)
TaiwanThailandVietnam
Brazil Chile
ColombiaPeru
located in 72 offices throughout 38 countries. (Figures as of Sept 2011)
5
PAREXEL Academy - Background
Founded:
2001 in Berlin (Germany/Europe)
Objective:
To provide high quality training for newcomers and To provide high quality training for newcomers and professionals in the biopharmaceutical and contract research industry.
511/30/2011
6
PAREXEL Academy – What we do
PAREXEL Academy
PostgraduateBachelor of
Science Training for the GCP-Training Japan
PAREXEL Academy
gCourses
Science in Clinical Research
(BSc)
Pharma-ceutical Industry
GCP Training for
Site StaffOncologyAcademy
Tailored In-house Training for Pharmaceutical Companies
Validated by the University of Wales, since 2008
Internal Trainingfor PAREXEL CRAs
1. Study Nurse Training
2. Investigator Training
1. Clinical Research Associate/ClinicalTrial Management, PAREXEL Academy Germany, since 2002
2. Certificate in GCP in cooperation with the National University of Singapore, Feb 2012
3. Cooperation with
6
Northeastern University Boston in process
11/30/2011
7
Who we teach
Over 1700 participants in all courses to date
680 Study Nurses 280 Investigators 443 Postgraduates 54 Undergraduates
Several hundred professionals from pharmaceutical companies
11/30/2011
8
Postgraduate Courses – Proven Success
443 graduates have completed our courses
92% of all graduates were placed
50% received job offers before the end of the course
811/30/2011
9
Postgraduate Courses
239 started work in these departments at PAREXEL
M i i /Cli i l O i 118Monitoring/Clinical Operations 118Clinical Logistics 64Data Management 42St d St t U U it 27Study Start-Up Unit 27Project Management 13Medical Services 22Regulatory Affairs 17Regulatory Affairs 17Peri-Approval Studies 5Proposal and Contracts 4Perceptive Informatics 3Perceptive Informatics 3Quality Assurance 2Biostatistics 1Medical Writing 1
9
Medical Writing 1
11/30/2011
10
Postgraduate Courses
170 graduates started work at other companies
PharmaceuticalIndustry:
Contract Research Organisations:
Institutes:Industry: Organisations:
Astra-ZenecaBausch&LombBiotronik
QuintilesCovancePRA Int.
BfArMHelios KlinikenTrial Coordinating Units in ot o
BayerBoehringer-IngelheimBootsGrünenthalMerckNovartis
tI3 ResearchIconPPD AccovionClin Research CologneEcron
a Coo d at g U tsHospitals or UniversitiesUniversity of Marburg
NovartisPfizerRoche PharmaSanofi-AventisSolvaySchwarz Pharma/UCB Stada
EcronEntimo BerlinGSO HamburgOmnicareSynarc Hamburg
StadaNovoNordisk
11/30/2011
11
COURSE OVERVIEW
Valerie Howarth-Gruender, BA, PGCE, RSA Dip
Course CoordinatorSenior Trainer PAREXEL Academy
11/30/2011
© 2010 PAREXEL International | Confidential
12
The Postgraduate Certificate Program DetailsCourse Structure
g gQualification Postgraduate Certificate in Good Clinical Practice
Course structure 4 modules taught sequentially
Delivery One week full-time face-to-face training (30 hours)One week self-directed learning (30 hours)
Academic value 4 x 4 Modular Credits (MC) = 16 MC (24 ECTS)( ) ( )
Course length 10 weeks: 8 teaching weeks1 revision week 1 examination week
Assessment A 2-hour written examination for each module.
Faculty Lecturers from PAREXEL Academy and NUS y y
Venue Department of Pharmacy, Faculty of ScienceNational University of Singapore
1211/30/2011
13
Selection Procedure
Prerequisites Bachelor degree in Medicine, Pharmacy, Life Sciences or related major.IELTS 7.0 or TOEFL equivalent*
Application procedure Written application with complete CV to NUSAGEDeadline: Monday 5th December 2011Deadline: Monday 5th December 2011
Selection procedure Assessment Centre comprising:p p gInterviewAptitude testCommunication skills test
11/30/2011
14
Course schedule
Week 1 13 Feb 2012 Drug Development Process 30 hrs contact
Week 2 20 Feb 2012 30 hrs directed learningee 0 eb 0 30 s d ected ea g
Week 3 27 Feb 2012 Regulatory Affairs 30 hrs contact
Week 4 05 Mar 2012 30 hrs directed learning
Week 5 12 Mar 2012 Conducting Clinical Research 30 hrs contactWeek 5 12 Mar 2012 Conducting Clinical Research 30 hrs contact
Week 6 19 Mar 2012 30 hrs directed learning
Week 7 26 Mar 2012 Client Relationship Management 30 hrs contact
Week 8 02 Apr 2012 30 hrs directed learning
Week 9 09 Apr 2012 EASTER
Week 10 16 Apr 2012 Timetabled Revison Sessions
Week 11 23 April 1 x 2-hour examination per day
11/30/2011
15
THE DRUG DEVELOPMENT PROCESS
Matthias Grossmann, MD, PhD
Clinical PharmacologistClinical PharmacologistPathophysiologist
Vice President and Principal ConsultantTrainer PAREXEL Academy
11/30/2011
© 2010 PAREXEL International | Confidential
16
History of Drug Development
Before 1800 use herbal remedies
After 1850After 1850 isolate the active principle understand symptoms of a disease
After 1920 recognize the cause of a disease (insulin, penicillin) discover putative target
After 1970 understand immunology and genetics produce human-specific compounds/biologicalsproduce human specific compounds/biologicals
After 2000 an era of individualized medicines?
11/30/2011
17
Drug Development: Success Rate
• Only 1 out of 50 drug candidates reaches clinical testingtesting
• Only 1 out of 5 of these drug candidates reaches the candidates reaches the market
• Clinical development is twice • Clinical development is twice as expensive as candidate selection
1711/30/2011
18
Learning Too Little Too LateDG
EKN
OWLED
Market Withdrawal!
Preclinical Phase IIb Phase III Phase IVPhase I‐IIa
18
TIME / MONEY
11/30/2011
19
Learning Too Little Too LateDG
EKN
OWLED
Preclinical Phase IIb Phase III Phase IVPhase I‐IIa
19
TIME / MONEY
11/30/2011
20
Orloff and Stanski 2009
2011/30/2011
21
Drug Development
is expensive time consuming often failsoften fails time is limited due to patent expiration
d l i i f t i t good planning is of paramount importance
Good planning needs good understanding…p g g g
11/30/2011
22
REGULATORY AFFAIRS
Bettina Merz-Nideroest, MPharm
PharmacistSenior Clinical Trial Specialist CTS
Trainer PAREXEL AcademyTrainer PAREXEL Academy
11/30/2011
© 2010 PAREXEL International | Confidential
23
An Early Clinical Trial
D J Li d d SDr. James Lind and ScurvyRoyal Navy Surgeon aboard HMS SalisburyScurvy: disease caused by deficiency of Vitamin CScurvy: disease caused by deficiency of Vitamin C
20th May 174712 scorbutic sailors divided into six pairs12 scorbutic sailors divided into six pairs
1) a quart of cider daily2) 3 x 25 drops of elixir of vitriol (sulfuric acid)2) 3 x 25 drops of elixir of vitriol (sulfuric acid)3) two spoonful of vinegar three times a day4) half a pint of sea-water5) t d l5) two oranges and one lemon6) a spicy paste (garlic) plus barley water
Group 5 experienced a remarkable recovery Group 5 experienced a remarkable recovery
2
11/30/2011
24
Conduct of Clinical Trials
Would it still be possible nowadays to conduct the study as Dr. Lind did in 1747?
Wh t th i t f t ti d d ti What are the requirements for starting and conducting a Clinical Trial?
What guidelines and laws must be followed?What guidelines and laws must be followed?
Who are the key players in clinical research?
What are their roles and responsibilities?
What documents are essential?What documents are essential?
Regulatory Affairs Module!
11/30/2011
25
Clinical Research
R l R ibilitiRoles Responsibilities
Ethics CompetentCommittee Authority
Investigator SponsorCROCRO
TrialSubjectSubject
Legal FrameworkProcesses Documents11/30/2011
26
CONDUCTING CLINICAL RESEARCH
Claudia Richter
MSc in Medical / Nursing Education Senior Clinical Research AssociateS i T i PAREXEL A dSenior Trainer PAREXEL Academy
11/30/2011
© 2010 PAREXEL International | Confidential
27
Process of a Clinical Trial
11/30/2011
28
What Happens on Site?
We will discuss and answer the following questions:
How are patient safety and data integrity assured in Clinical Trials?
What does a Clinical Research Associate (CRA) have to do and why?
Why is it so interesting to work with site staff in Clinical Trials?
What are the challenges for a CRA in Clinical Trials?
2
11/30/2011
29
CRA - Responsibilities and Interactions
Investigatorsand site staff
Client(Sponsor)
CRA
Other Other functional
groupsVendors
11/30/2011
30
CLIENT RELATIONSHIP MANAGEMENT
Sabine Brunschoen-Harti, PhD
ScientistDirector Operations Process, Quality & Training
Trainer PAREXEL AcademyTrainer PAREXEL Academy
11/30/2011
© 2010 PAREXEL International | Confidential
31
Client Relationship Management
We will examine the following topics:
Managing studies with special requirements
The importance of good communicationThe importance of good communication
Good document practice requirements
Preparing for audits and inspections
Detecting and managing non-compliance and fraud
11/30/2011
32
The Importance of Good Communication
During study visits Addressing quality issues Clarifying issues
Good Documentation Practice RequirementsGood Documentation Practice Requirements Data, documents, signatures
Advanced Monitoring Visit Report Writing Addressing the requirements of ICH/GCP Meeting client expectations Meeting client expectations Meeting regulatory requirements
11/30/2011
33
Quality Control
Identifying, managing and dealing with: poor performance
li non-compliance fraud
Audits and Inspections Preparation with site Communication with investigators Communication with investigators Communication with inspectors Do’s and Don’ts… Common Findings
11/30/2011
34
Assessment and Marking
Assessment The course is assessed via 4 x 2-hour written examinations
at the end of the course (1 per module) during exam weekat the end of the course (1 per module) during exam week. The exams are a mixture of multiple choice, short answer
and case study questions.
MarkingThe Postgraduate Certificate is marked according to the UK
ki tmarking system:
70% and over Distinction 60% - 69% Merit40% - 59% Pass
12/2/2011
35
Work Placement at PAREXEL
Optional
All d d i i All students guaranteed interviews Takes place at the end of the course Approx. 6 months May to October 2012 Paid at local rates APAC region APAC region Testimonial on completion Job interview in 5th month for full-time position
11/30/2011
36
The Work Placement Process
Assessments and
Selection of Students l t th
Students l f
Interns f
Selection i t i
Hiring of interns for Candidates
for the PG Certificate
Program in GCP
complete the PG Certificate
Program
apply for placements
perform 6-month
Work Placement
interviews during 5th
month
interns for full-time positions
3611/30/2011
37
Locations
Criterion: English speaking environment
Suggested countries (others can be added):
Korea*China*AustraliaIndiaSingaporeHong KongTaiwan*J *Japan*
* Locations will need local language capability
3711/30/2011
38
Who Pays For What
PAREXEL International:
Monthly payment according to local pay practices
Students:
Travel costs to/from placement Accommodation Visa fees (if applicable) Visa fees (if applicable)
3811/30/2011
39
Possible Careers in Clinical Research
Clinical Research Associate, Clinical Monitor, Clinical Monitoring Associate, Clinical Trial Monitor, Clinical Research Specialist, Clinical Research Assistant Field Based Monitor Medical Writer Clinical Research Assistant, Field Based Monitor, Medical Writer, Drug Supply Manager, Clinical Site Manager, Clinical Trial Assistant, Study Coordinator, Clinical Research Coordinator Clinical Study Manager, Clinical Manager, Clinical Research Manager, Director Clinical Research Management, Clinical P j t S i ti t P j t M t A i t t Cli i l P j t Project Scientist, Project Management Assistant, Clinical Project Manager, Medical Field Manager, Clinical Trial Manager, Clinical Scientist, Drug Safety Manager, Data Entry Assistant, Clinical Writer, Manager Drug Regulatory Affairs, Regulatory Specialist, Head of Drug Safety Regulatory Affairs Manager Manager Drug Head of Drug Safety, Regulatory Affairs Manager, Manager Drug Safety, Data Manager, Database Manager, Clinical Data Manager, Clinical Programmer, Clinical Data Associate, Database Administrator, Senior Clinical Data Coordinator, Line Manager, Medical Service Liaison Manager, Field Application
l l l l l l lSpecialist Molecular, Clinical Trial Specialist
11/30/2011
40
Any questions?
11/30/2011
