Post on 15-Jun-2018
1st PDA Europe Annual Meeting
The Parenteral Drug Association presents:
T H E F U T U R E I N I N J E C T A B L E S
2016
30 June - 1 July Root Cause Investigation
30 June - 1 July Development of Pre-Filled Syringes
30 June Test Methods for Pre-Filled Syringes
30 June Cleaning and Disinfection
30 June How to Find the Right GMP for APIs
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28-29 June 2016 Estrel Hotel Berlin
Berlin | Germany
Gold SponsorPlatinum Sponsor Silver Sponsor Media Partner
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LETTER FROM THE CHAIR
Dear Friends, Colleagues, Collaborators and Peers,We are all witnessing a paradigm shift in scientific, technical and regulatory approaches to healthcare. Innovative technologies raise the quality and safety of our manufacturing and distribution processes and offer increased efficiencies and flexibilities. Regulatory oversight is becoming increasingly risk based and strives for convergence on a global scale. Our industry is evolving towards an increasingly agile and flexible manufacturing mode that can accommodate shifting demands, deliver innovative therapies, and master current and future healthcare challenges. 21st century manufacturing will be light years away from the traditional approaches we were accustomed to.
On 28-29 June 2016, PDA Europe’s first Annual Meeting The Future in Injectables will provide you with a first-hand opportunity to stay current and apprehend future advances in modern sterile manufacturing and quality oversight. We will offer you a very unique program with new and exciting topics, specifically aimed at reflecting innovative approaches and cutting edge technologies.
Renowned industry leaders and regulators will share their experience with you in daily plenary sessions and a series of parallel tracks. The opening plenary session will focus on strategies developed by partakers in healthcare to strive in the context of globalization and rapid scientific innovation. Concurrent sessions are designed to address many of the current challenges our industry and regulators faces. They will feature over thirty presentations with practical examples and case studies, and offer the perfect blend of industry updates, educational topics, technical advances and trends in regulatory oversight. We will dive deeply into continuous manufacturing, flexible facilities, modern analytical technologies, automation and robotics, blow-fill-seal technology, big data processing and ‘industry 4.0’, serialization and product tracking implementation, data integrity, innovative injection devices, and – last but not least – the related regulatory aspects. The conference will conclude with an outlook to the future of our industry, covering facilities, manufacturing and therapies of the future in a global context.
Opportunities to interact with speakers, industry peers, regulators, exhibitors and PDA leadership will be plenty. They include extended networking breaks, interactive roundtable discussions with PDA chapters from Europe and Japan and a very special European networking reception on the evening of June 28th.
As an extended offer, on June 30th and July 1st PDA Europe will be hosting several in-depth training courses that are designed to complement topics presented at the conference.
PDA Europe’s first Annual Meeting The Future of Injectables shows once again PDA’s commitment to bringing manufacturing technology advances to the forefront and facilitating discussions between industry, suppliers and regulators. You will leave the conference richer, both in terms of knowledge and relationships, which will benefit your career and organization.
Mark your calendars now and plan to join us in Berlin/Germany from June 28th to July 1st, 2016.
On behalf of the program planning committee and PDA staff, I look forward to welcoming you there!
Ursula Busse, PhD MBA, Novartis Group Quality Conference Chairwoman
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1 Ursula Busse, Conference Chair, Novartis
2 Jette Christensen, Novo Nordisk
3 Véronique Davoust, Pfizer
4 Derek Duncan, LIGHTHOUSE
5 Gabriele Gori, GSK
6 Eric Meier, Novartis
7 Thomas Pospiech, Optima Pharma
8 Stephan Rönninger, Amgen
9 Mihaela Simianu, Amgen
10 Ryan Smith, Sight Machine
11 Jochen Strube, Clausthal University of Technology
12 Georg Roessling, PDA Europe
S C H E D U L E A T A G L A N C E
28 June 29 June
9:00 – 19:00 7:30 – 17:30
1st PDA Europe Annual Meeting Conference, Exhibition
30 June 9:00 – 17:00 Test Methods for Pre-filled Syringe Systems
One-Day-Training Course
30 June 9:00 – 18:00 Cleaning and Disinfection One-Day-Training Course
30 June 9:00 – 17:30 How to Find the Right GMP for APIs One-Day-Training Course
30 June 01 July
9:00 – 18:00 9:00 – 16:30
Root Cause Investigation Two-Day-Training Course
30 June 01 July
9:00 – 17:45 9:00 – 16:30
Development and Manufacturing of Pre-filled Syringes
Two-Day-Workshop
For latest information, please visit: europe.pda.org/AnnualMeeting2016
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1 Ursula Busse, Conference Chair, Novartis
2 Stephan Rönninger, Amgen
3 Jette Christensen, Novo Nordisk
4 Derek Duncan, Lighthouse
5 Gabriele Gori, GSK
6 Eric Meier, Novartis
7 Thomas Pospiech, Optima Pharma
8 Mihaela Simianu, Amgen
9 Ryan Smith, Sight Machine
10 Jochen Strube, Clausthal University of Technology
11 Georg Roessling, PDA Europe
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CONFERENCE AGENDA
Tuesday, 28 June
9:00 Welcome: Opening Remarks, Introduction & PDA Awards Georg Roessling, PDA Europe Ursula Busse, Novartis, Conference Chair
Opening Plenary Moderator: Ursula Busse, Novartis
9:15 The Quality Journey: From Good to Great Martin van Trieste, Amgen
9:45 A Question of Trust – Hard Won, Easily Lost John Johnson, NSF Health Sciences
10:15 Overcoming the Divide of Excellence & Quality Thomas Friedli, University of St. Gallen
10:45 Coffee Break, Poster Session & Exhibition,European Chapter Activity
11:15 Regulatory Considerations for Continuous Manufacturing: EU Perspective
Jean-Louis Robert, European Medicines Agency, Chair of the CHMP/CVMP Quality Working Party
11:45 The International Role of PIC and PIC/S in Harmonizing Inspections Paul Hargreaves, MHRA, PIC/S
12:15 Q&A, Discussion
12:45 Lunch Break, Poster Session & Exhibition,European Chapter Activity
13:40 Transition to Parallel Tracks
P A R A L L E L T R A C K S
Rooms A B C
TRACK A TRACK B TRACK CSession 1 Continuous Manufacturing
& Flexible Facilities TestingLifecycle Management
and Innovation:Are they Mutually Exclusive?
27 May 2016
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CONFERENCE AGENDA
Moderators: Mihaela Simianu, Amgen Jette Christensen, Novo Nordisk Ursula Busse, Novartis
Session 1 Continuous Manufacturing& Flexible Facilities Testing
Lifecycle Management and Innovation:
Are they Mutually Exclusive?
13:45 Concepts and Solutions for Continuous Manufacturing
Eric Meier, Novartis
Attribute Focus to Achieve the Quality Target Product Profile (QTPP)
Rohini Deshpande, Amgen
Challenges of Pharma Industry with Lifecycle Approach
Anders Vinther, Sanofi Pasteur
14:15 Process Development and Engineering Challenges for Future Manufacturing of Biologics
Jochen Strube, Clausthal University
Post Approval Lifecycle Manage-ment of Analytical Control Systems
Emma Ramnarine, Genentech / Roche
From QbD to Lifecycle Management: Regulatory Perspective of Guide-lines that should Encourage Innovation - Opportunities and Challenges
Jean-Louis Robert, European Medicines Agency, Chair of the CHMP/CVMP Quality Working Party
14:45 Traceability in Continuous Manufacturing
Jochen Thies, Glatt Group
All-in-One Solution for Parenteral Containers CCI Testing and Headspace Gas Verification
Andrea Simonetti, Bonfiglioli Engineering
Recent Initiatives put Forward by the WHO to Facilitate Post-Approval Change Management for Vaccines
DianLiang Lei, WHO
15:15 Q&A, Discussion Q&A, Discussion Q&A, Discussion
15:45 Coffee Break, Poster Session & Exhibition,European Chapter Activity
P A R A L L E L T R A C K S
Rooms A B C
TRACK A TRACK B TRACK CSession 2 Automation & Robotics Testing Blow-Fill-Seal
Moderators: Masahiro Akimoto, OtsukaStephan Rönninger, Amgen
Jette Christensen, Novo Nordisk Georg Roessling, PDA Europe
16:15 Nanoparticle Technology in Phar-maceutical Applications
Sanshiro Nagare, Nara Machinery
Testing of Final Product during Scale Up: Lessons Learned
Derek Duncan, LIGHTHOUSE
Speaker to be confirmed
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CONFERENCE AGENDA
Session 2 Automation & Robotics Testing Blow-Fill-Seal
Moderators: Masahiro Akimoto, OtsukaStephan Rönninger, Amgen
Jette Christensen, Novo Nordisk Georg Roessling, PDA Europe
16:45 A New Generation Packaging Line for Filled Product in Carton with Integrated Dividers
Hiroaki Mizuno, Omori Machinery
CCIT Technology on BFS Containers: From the High Speed Testing Prospective, the Testing Reliability and the Validation Approach
Jaime Combo, Wilco
Basic Principles and Regulatory Requirements for BFS Technology including Qualifications and Validation Aspects
Christoph Bohn, Holopack Packaging Technology
17:15 Overview of the Low Voltage Electron Beam Sterilization System and its Benefits
Koji Kawasaki, AirEX
In-Line Automated Visual Particle Inspection of BFS Containers for Injectable Drug Products
Heino Prinz, rommelag
Specific Aspects for Manufacturing and Autoclaving of BFS Products
Martin Haerer, Holopack Packaging Technology
17:45 Moderator:Masahiro Akimoto, Otsuka
Roundtable DiscussionBusiness Opportunities Japan
Session Speakers
Moderator:Gabriele Gori, GSK Vaccines
Roundtable Discussion Final Product Control:CCIT & Visual Inspection– Do we need it? What will Annex 1 bring?
Session Speakers
Experience with Filling of Biological Products with Cool BFS Technology
Otto Schubert, Maropack
18:30 End of Day 1
19:00 Joint Departure & Networking Event @ Pier13
Summer in BerlinNetworking Event
The Parenteral Drug Association presents:
Meeting Point: Hotel Estrel - PDA Registration Desk
Shuttle Bus leaving at 19:00hShuttle Bus returning to the Estrel Hotel 22:30hDress Code: Casual Summer Look
Please confirm your attendance at the PDA Registration Desk. If you have any dietary requirements, please let us know.
Pier 13 | Tempelhofer Damm 227 | Tempelhofer Hafen | 12099 Berlin
SPECIAL ACT:
HEAR THE FIRST PDA BAND PLAYING.
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CONFERENCE AGENDA
Wednesday, 29 June
7:30 Welcome Coffee
M O R N I N G R O U N D T A B L E S
8:00 MEET THE PDA CHAPTERS
PDA has 24 Chapters around the world with local programs and resources to help you stay informed, interact with your peers, and facilitate exchange with the pharmaceutical and biopharmaceutical industry. Meet six of these chapters in this morning session and get to know the chapter presidents and industry peers in your region!
ITALY / SWITZERLAND (TESSIN)
FRANCE UK IRELAND ISRAEL JAPAN
I N T E R E S T G R O U P M E E T I N G T E C H T R A N S F E R ( T T I G )
8:00 • Scope and Activities• Technical Report #65• TT IG current picture
- Membership, Geographic distribution, Expertise onboard
• Goals for 2016 & Next steps• Q&A, Discussion
IG Leader:Mirko Gabriele, Patheon
P A R A L L E L T R A C K S
Rooms A B C
TRACK A TRACK B TRACK CSession 3 Big Data Processing / Industry 4.0 Regulatory Track Technical Track
Moderators: Georg Roessling, PDA Europe Gabriele Gori, GSK Vaccines Mihaela Simianu, Amgen
9:10 Industry 4.0 - Readiness for Pharmaceutical Companies
Andreas Traube, IPA Fraunhofer Institute
What an Inspector Needs to Know About Assessment
Kevin O’Donnell, Health Products Regulatory Authority, Ireland (HPRA)
Serialization Requirements in Europe
Véronique Davoust, Pfizer
9:40 Technology Road Map Industry 4.0
Francisco Herrador, Altran
Challenges in Pharmaceutical Industry-SME Perspective
Andreas Sachse, CPL SACHSE
Serialization and Product Tracking Implementation in a Global Environment
Michael Ritter, Novartis
27 May 2016
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CONFERENCE AGENDA
Session 3 Big Data Processing / Industry 4.0 Regulatory Track Technical Track
10:10 Manufacturing & Big Data: Approaches for Pharma
Toni Manzano & Pep Gubau, BigFinite
Import of Pharmaceutical Products: Annex 21, OECD Guideline
Stephan Rönninger, Amgen
Track and Trace Implementation in Iran
Akbar Abdollahi, IFDA
10:40 Q&A, Discussion Q&A, Discussion Q&A, Discussion
10:55 Coffee Break, Poster Session & Exhibition,European Chapter Activity
11:25 Transition to Parallel Tracks
P A R A L L E L T R A C K S
Rooms A B C
TRACK A TRACK B TRACK CSession 4 Modern Analytical Techniques Data Integrity Drug Administration
Moderators: Derek Duncan, LIGHTHOUSE Stephan Rönninger, Amgen Eric Meier, Novartis
11:30 Predictive Modelling and Real-time Analytics Applied to Fill and Finish Operations
Cenk Undey, Amgen
DI – A Criminal Act? Overview, Clarification, Definition
Anil Sawant, Merck & Co.
Innovative Drug Delivery
Ian Thompson, Ypsomed Delivery Systems
12:00 Digital Transformation for Biotech-nology: A Big Data Approach to Manufacturing Analytics
Ryan Smith, SightMachine
Data Integrity for Computer Systems – A Bumpy Road to Compliance
Wolfgang Schumacher, Roche
Smart Medication–Where Electronics meet Drug Delivery
Markus Bauss, SHL Connect
12:30 Automated Media Fill Inspection
David Brueckner, Roche
Data Integrity – A Holistic Approach
Madlene Dole, Novartis
Best Practice in Glass Handling During Ddevice Development and Commercialization
Thomas Schoenknecht, SHL Medical
13:00 Q&A, Discussion Q&A, Discussion Q&A, Discussion
13:15 Lunch Break, Poster Session & Exhibition,European Chapter Activity
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CONFERENCE AGENDA
Session 5 : Closing Plenary - Future Developments Moderator: Ursula Busse, Novartis
14:15 Past & Future of Injectable Dosage Forms for Biologics – Quo vadis, Parenteralia?
Hanns-Christian Mahler, LONZA
14:45 Necessities and Possibilities of New Manufacturing and Facility Design Maik Jornitz, G-Con Manufacturing
15:15 Requirements and Opportunities for the “Parenteral Facility of the Future”
Morten Munk, NNE Pharmaplan
15:45 Coffee Break, Poster Session & Exhibition,European Chapter Activity
16:15 Challenges for Medical Treatment in Future Samvel Azatyan, WHO
16:45 Panel Discussion: The Future of Injectables
Participants:• Hanns-Christian Mahler, Lonza
• Samvel Azatyan, WHO
• Paul Hargreaves, MHRA and Chair of PIC/S
• Steven Lynn, Novartis (and former FDA)
17:30 Closing Remarks, End of Conference & Farewell Coffee
15-16 November 2016 Olivia Balmes HotelBarcelona | Spain
Register by 15 Oct 2016 and SAVE!
2016 PDA Europe
Outsourcing & Contract Manufacturing
The Parenteral Drug Association presents:
14 NovemberRisk-based Approach for Prevention and Management of Drug Shortages
15-16 NovemberConference, Exhibition
17 November Quality by Design for Biopharmaceuticals
17-18 NovemberRoot Cause Investigation
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During all coffee and lunch breaks, you have the opportunity to visit the Poster Session located in the Exhibition Area. Poster presenters will be happy to welcome you and answer your questions.
Shlomo Sackstein, Biopuremax
Biopuremax- Pretreatment Water System
Kavita Ramalingam lyer, Merck Sharp & Dohme Corp.
Annex 2 and a Case Study Enabling Risk-Based Biopharmaceutical Facility Design Approaches
Paul Lopolito, STERIS Corporation
A Scientific Approach to Maintain your Stainless Steel Surfaces
POSTER SESSION
This Poster Session is still open for your proposal. Please submit directly to Sylvia Becker at becker@pda.org
Elizabeth Rivera, STERIS Corporation
Cleaning Validation Concerns for Continuous Manufacturing
Christa Jansen-Otten, West Pharmaceutical Services
Component Selection Strategies for PFS: Risk Mitigation, Performance and Larger Injection Volume Driving Innovative Solutions
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ESTREL HOTEL & CONGRESS CENTERBERLIN
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Table Top (3 x 2 m)
C: Chapter / Table Top (2 x 2 m)
Diamond Sponsor (4 x 2 m)
Platinum Sponsor (3 x 2 m / 4 x 2 m)
Gold Sponsor (3 x 2 m)
Silver Sponsor (3 x 2 m)
Buffet/Coffee Station
FLOOR PLANESTREL HOTEL BERLIN
cGMP Processing of Sterile Products Afton Scientific
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CONFERENCE AGENDA
www.terumo-gps.com
Global Pharmaceutical Solutions
Sensitive biopharmaceuticals? We take the challenge
• Drug delivery solutions & technologies for injection and infusion
• Expert platforms in pharmaceuticals, polymers, coatings, precision and miniaturization technologies
• Uncompromised Quality and Regulatory Affairs support
• Committed to improved drug delivery and patient comfort
Ad_Plajex_white_A4_2015_0910.indd 1 10/09/15 16:42
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The Parenteral Drug Association presents...
PDA Education Program
30 June 2016Test Methods for Pre-filled Syringe Systems One-Day Training Course
30 June 2016Cleaning and Disinfection One-Day Training Course
30 June 2016How to Find the Right GMP for APIs One-Day Training Course
30 June - 01 July 2016Root Cause Investigation Two-Day Training Course
30 June - 01 July 2016Development and Manufacturing of Pre-filled Syringes Two-Day Workshop
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ONE-DAY TRAINING COURSE
Who Should Attend:
This course will be beneficial to individuals work-ing in Product Development, Quality Management, Regulatory Affairs and Manufacturing of syringe systems and related delivery devices
Learning Objectives:
Upon completion of this course, you will be able
• To understand the pros and cons of the different materials used for the Pre-filled Syringe
• To apply existing standards and monographs for specific syringe testing
• To explain the testing rationales used for test meth-ods at different stages
• To create a own testing plan according to your spe-cific application
Horst Koller, CEO, HK Packaging Consulting GmbH
Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focussing on Technical, Regulatory and QM-Support around Primary and Sec-ondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.
OverviewPre-filled Syringes (PFS) are used for different applications and throughout many therapeutic areas. They are available in glass and polymer, with and without needles already pre-attached to the syringes. Pre-filled Syringes fulfill two tasks: storage container and delivery device in one and the same system.The more components are used in such systems the more complex it will get, additionally if such Pre-filled Syringes are used in Auto-injectors or other delivery devices.
This one-day course will cover a short introduction into common materials used for the development and manufacturing of syringe systems. The main focus is on the test methods which are relevant for the different stag-es of a Pre-filled Syringes.
Test Methods for Pre-filled Systems
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TRAINING COURSE AGENDA
27 May 2016
Thursday, 30 June 2016 9:00 – 17:00
9:00 Welcome
9:15 Introduction to Syringe Systems & Components• Polymer Syringes• Glass Syringes• Rubber Components and Closures
10:15 Luer Cone and Luer Lock Compliance Testing for Glass and Polymer Syringes
11:00 Coffee Break
11:30 Requirements for the Empty Sterile Sub-assembled Syringe Ready for Filling• Cone Breakage• Flange Breakage• Leakage
12:30 Lunch Break
13:30 Requirements for the Empty Sterile Sub-assembled Syringe Ready for Filling (continued)• Break-loose and Gliding Forces• Needle Penetration• Particulate Matter• Endotoxins
14:30 Requirements for Finished Pre-filled Syringes • Pharmacopeia• FDA
15:30 Coffee Break
16:00 Additional Testing for Use in Delivery Devices• Auto-Injectors
17:00 End of Training Course
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ONE-DAY TRAINING COURSE
Peter Koger, Technical Sales Manager International, Veltek Associates Inc.
Peter Koger MSc. has been active in life science for over 35 years. First 12 years were spend in different laboratories in microbiology and the remainder working for various international organizations, active in the life science/pharmaceutical industry. For about 20 years Peter has been a technical resource to the pharmaceutical industry in relation to viable monitoring, cleaning & disinfection, and other aspects related to Aseptic Manufacture and Contamination Control. Since 2002, he is a frequent industry speaker and since 2004, Peter has been a faculty member of PDA and other training institutes. Peter worked with several companies to help them get to best practice
level in Cleaning & Disinfection. Since 2005, Peter is working with Veltek Associates Inc., a leading manufacturer of sterile disinfectants, detergents, viable monitoring equipment and several other innovative products focused on Contamination Control in the Pharmaceutical and Biotech industry. In his role, Peter is Technical Sales Manager responsible for Europe and part of Asia.
Cleaning and DisinfectionA practical approach
Who Should Attend:
• Production management• Operators responsible for/involved in C&D• Quality/Microbiology management• Quality personnel involved in C&D
Learning Objectives:
At the end of the workshop attendees should be able to develop or evaluate an existing cleaning and disinfection program in line with regulatory expectations and facility’s requirements for contamination control of classified areas.
Overview
This interactive course deals with all aspects of cleaning and disinfecting a sterile manufacturing facility. The information shared will encompass Regulatory aspects, Environmental Monitoring, Contamination sources, Selection of disinfectants and cleaning agents, the Validation and how they should be used properly.
Thursday, 30 June 2016 9:00 – 18:00
9:00 Welcome & Introduction
Subject Introduction | General Framework | Directives / Guidelines / Expectations
10:30 Coffee Break
Environmental Monitoring and Risk Analysis | Root Cause of Contamination
12:30 Lunch Break
13:30 Selection criteria | Validation | Means and Methods
15:30 Coffee Break
Practical Approach | Supplies and Tools | Case Studies
18:00 End of Training Course
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Advanced aseptic packaging in one operation cycleReliable – Simple – Cost-Effective
bottelpack® Technology:• Integrated clean room US-class 100• Recognized by GMP, FDA, JP …• Aseptic packaging of liquids, creams, ointments …• Endless container designs in PE, PP…
Your benefits:• Tamper-proof packaging• Easy to open• Simple to use• Shatter-proof, no splinter hazard
www.rommelag.com
rommelag agP.O. Box · CH-5033 Buchs, SwitzerlandPhone: +41 62 834 55 55 Fax: +41 62 8345500E-mail: mail@rommelag.ch
rommelag Kunststoff-MaschinenVertriebsgesellschaft mbHP.O. Box 1611 · D-71306 Waiblingen, GermanyPhone: +49 7151 95811-0 Fax: +49 7151 15526E-mail: mail@rommelag.de
rommelag USA, Inc.27905 Meadow Drive, Suite 9Evergreen CO 80439, USATel: +1.303. 674.8333 Fax: +1.303.670.2666E-Mail: mail@rommelag.com
rommelag Trading (Shanghai) Co., Ltd. Room 104~107,1st Floor, No.510 Zhongshan South 2nd Road,Xuhui District, Shanghai, 200032 P.R. ChinaPhone: +86 21 5153 4967, +86 21 5153 4968 Fax No.: +86 21 5153 4969E-mail: romcn@rommelag.com
ADV_3in1_EN_164x235mm_2015.indd 1 05.10.15 16:45
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An ICH Q7 expert working group member instructs
ONE-DAY TRAINING COURSE
Who Should Attend:
This course is designed specifically for those in-volved or interested in the manufacturing of APIs, the suppliers to API manufacturers or CMOs of APIs. The targeted audience comes from:
• Quality• Production• Logistics • Engineering
Learning Objectives:
Upon completion of this course, the attendee will be able to:
• Avoid an over-interpretation of the GMP requirements in API manufacturing
• Know the keywords of the ICH Q7 guideline and how to interpret the guideline correctly
• Know the different responsibilities of quality and production
• Realize the additional GMP requirements for Bio-technology APIs
• Understand the meaning of ‘critical’ and its impact on quality processes
• Determine at which point in API manufacturing GMP needs to be applied
• Know how materials are re-used in a correct manner• Know what needs to be documented and which
departments are involved
Lothar Hartmann, Ph.D., Managing Director, IQP Consulting
Lothar Hartmann served at Hoffmann-La Roche in numerous functions nationally and globally. Lothar acted as Global Head of “Pharma-ceutical Quality Systems & External Relations”, interacting with regulatory health authorities and associations, and as “Global Head of Knowledge Management”. He also acted as Head of Quality at Crucell Berne, a Johnson & Johnson Group of Companies, before he built up his own company ‘IPQ Consulting’. Lothar Hartmann served for more than 10 years on the board of APIC/CEFIC as Vice-Chairman. In this function, he was nominated for the ICH Q7a Expert Working Group, writing the worldwide-harmonized GMPs for APIs. In this effort,
he also was FDA awarded in May 2004. He also founded and chaired the internationally recognized EBEs BioManufacturing Working Group for a number of years. Lothar is co- and lead-author of various documents published by CEFIC/APIC and EBE (European Biopharmaceutical Enterprises). He also served on the “Board of Directors” of PDA, chaired the European Interest Group on Quality Systems and was co-founder of PDA’s “Paradigm Change in Manufacture” (PCMO) project which had the objective to address practical solutions for the day-to-day business of the new paradigm of ICH Q8 – Q11. Lothar Hartmann graduated from the Technical University of Berlin.
OverviewWhen API manufactures received their own GMP guideline by ICH, an important step was reached since there are significant differences between GMP requirements for Drug (Medicinal) Products and those for APIs.
This course will provide practical guidance of key aspects laid down in the ICH Q7 guideline. It will clarify and lay out the appropriate GMP standard to be applied by API manufacturers. In particular, it will address GMP related topics of quality, production, logistics, engineering and biotechnology.
PDA Europe is proud to offer participants this unique opportunity to receive first-hand knowledge, interpretation and understanding of ICH Q7, and to ask questions to one of the ICH Q7 authors.
How to Find the Right GMP for APIs:
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TRAINING COURSE AGENDA
27 May 2016
Thursday, 30 June 2016 9:00 – 17:30
9:00 Welcome & Expectation Round of Participants
9:30 Regulatory Environment for APIs
10:00 Quality
10:30 Coffee Break
11:00 Workshop (Draw Flowchart for Handling Deviations/Investigations)
11:30 Discussion of Outcome of Workshops
12:00 Keywords of ICH Q7
12:30 Lunch Break
13:30 Documentation
14:00 Workshop (Key Items of Major SOPs)
14:30 Discussion of Outcome of Workshops
15:00 Coffee Break
15:30 General GMPs for Production, Logistic & Engineering
16:00 Re-use of Materials
16:30 Special Requirements for Biotechnology
17:00 Final Discussion Round
17:30 End of Training Course
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TWO-DAY TRAINING COURSE
Who Should Attend:
Alumni of this program typically (though not exclu-sively) have a background in:
• Quality• Risk management• Regulatory affairs• Compliance• Manufacturing• Product development• CAPA• Supply chain & purchasing• Production• Engineering• Project management• R&D• Fraud management• and more
Learning Objectives:
Upon completion of the workshop, participants will able to immediately, effectively, and efficiently apply the methodology to:
• Identify the technical root cause(s), that is, the change(s) that occurred.
• Identify systemic root cause(s), that is, any underlin-ing breakdown in the organizations broader systems that allowed the change(s) to occur.
• Implement a comprehensive corrective and/or pre-ventive action plan to restore performance.
• Implement a control plan to minimize and/or pre-vent recurrence.
Rob Weaver, President of Weaver Consulting
Founded in 2003, Weaver Consulting is a two-person enterprise comprised of Tom Weaver and Rob Weaver. They are quality and oper-ations improvement consultants who focus their business exclusively on root cause analysis. With a combined 40+ years’ experience and a client base that expands worldwide, they have helped organizations across a multitude of highly regulated industries, including pharmaceutical, medical device, aerospace, defense, financial services, food & beverage, consumer products, automotive, telecom-munications, semiconductors, and many more, successfully implement their premier root cause analysis methodology, Root Cause
Investigation for CAPA. Both Tom and Rob held titles of Vice President in their respective careers before joining the firm, Tom with Baxter Healthcare and Rob with Wells Fargo & Company.
OverviewRoot Cause Investigation for CAPA is an informative, practical, and engaging two-day workshop teaching a system-atic, science based, and proven methodology ideal for investigating any performance change. Examples: change in the performance of a product (tangible or intangible), machine or equipment, work process or system (physical or virtual), escalated customer complaints, etc. Based upon 40+ years’ experience, the methodology integrates problem solving techniques from Total Quality Management (TQM), Six Sigma, Kaizen, DMAIC (define, measure, analyze, improve, control), as well as other problem solving and process improvement techniques.
On day one, the participants are introduced to the seven step root cause investigation methodology. An Investi-gation Roadmap is provided to guide the participants through the steps and suggest appropriate tools. After each step is presented leveraging an instructor case study, the participants immediately apply the learning on their own case study (which is based upon a real life investigation). On day two, several hours are devoted to strength-ening the participants’ skills leveraging the methodology through practice on another, more complex, real life case study. As the participants work on this case study they will compare their work with that of the investigation conducted by the real team.
Participants will be emailed a set of electronic templates. These templates, plus the investigation roadmap, guide the investigator through the methodology and provide the basis for documentation.
Root Cause Investigation for CAPA
23europe.pda.org/AnnualMeeting2016
TRAINING COURSE AGENDA
Thursday, 30 June 2016 9:00 – 18:00
9:00 Welcome & Introduction• Define technical CAPA problem• Common investigation mistakes• Investigation Roadmap template• Introduce 1st participant real life case study
10:00 Step 1: Define the Performance Problem• Introduce instructor case study• Problem statement• Problem description
10:30 Coffee Break
11:00 Step 1 Continued• Problem description continued• Workshop• Flow chart process(es) being investigated & identify key
inputs• Workshop• Time of events• Team charter including performance & cost savings goals
12:00 Lunch Break
13:00 Step 2: Collect Data• Determine data needed• Data collection tools & techniques• Data measurement plan• Workshop
15:00 Coffee Break
15:30 Step 3: Identify Possible Causes• Time of changes• Differences between Is & Is Not facts• Workshop• Changes associated with identified differences• Review risk analysis• Brainstorming techniques• Workshop
16:30 Step 4: Test Possible Causes• Test possible causes against facts• Summarize testing leveraging contradiction matrix• Historical perspective of investigations• Workshop
17:30 Step 5: Identify Technical & Systemic Root Causes• Verify assumptions• Conduct studies/experiments• Identify technical root cause(s)
18:00 End of Day 1
27 May 2016
Friday, 1 July 2016 9:00 – 16:30
9:00 Step 5 Continued• dentify systemic root causes
9:30 Step 6: Determine Corrective/Preventive Actions• Mistake proofing techniques• Variation reduction & optimization techniques• Corrective/preventive actions• Acceptance criteria
10:30 Coffee Break
11:00 Step 6 Continued• Risk mitigation• Control plan• Workshop
11:45 Step 7: Verify Corrective/Preventive Actions• Implement & measure corrective/preventive actions• Evaluate control plan• Determine additional preventive actions
12:00 Lunch Break
13:00 Second Participant Real Life Case Study• Introduction• Workshop to develop problem statement, problem
description, identify possible causes• Workshop to collect data• Workshop to test possible causes
15:00 Coffee Break
15:30 Second Participant Real Life Case Study Continued• Workshop to determine corrective/preventive actions
including risk mitigation, control plan, acceptance criteria
13:00 Closing Remarks• Compare/contrast this investigation methodology
with traditional approach• Shortcuts• Simple investigations• Difficult investigations• Investigation report• Return on investment• references
16:30 End of Course
24 europe.pda.org/AnnualMeeting2016
Including hands-on exercises with equipment for processing, inspection and control
TWO-DAY WORKSHOP
Who Should Attend:
This course offers valuable insights and updates for anyone involved in development, production, quality, and purchasing of pre-filled syringes and relevant equipment
Learning Objectives:
You will learn how:
• Processes involved in primary packaging manufac-turing, filling and processing influence quality
• Relevant equipment can be used to achieve reproducible quality
Development and Manufacturing of Pre-filled Syringes
Overview
This two-day workshop will provide an overview of relevant practical aspects and trends of developing and processing pre-sterilized primary packaging systems. It will also focus on hot topics such as aseptic environments, particulates, silicone and single-use filling. In addition to theoretical insights, participants will have the opportunity to use equipment and perform testing by themselves in hands-on sessions. Processing steps, inspection and quality aspects will be demonstrated using state-of-the-art technology.
Moderator: Christa Jansen-Otten, Director Marketing PFS Europa, West Pharmaceutical Systems Horst Koller, CEO, HK-Packaging Consulting
Speaker: Simone Biel, Field Marketing Specialist SU, Merck Millipore Josef Veile, Technical Director, Groninger Patrizia Wenzel, Sales Manager, Biesterfeld Spezialchemie
Faculty
25europe.pda.org/AnnualMeeting2016
WORKSHOP AGENDA
27 May 2016
Thursday, 30 June 2016 9:00 – 17:45
9:00 Welcome and Introduction Christa Jansen-Otten, West
9:15 Market Overview and Trends in Primary Packaging:• Global & Regional Pharmaceutical Market / Injectable Market /
Challenges / Changes in Manufacturing / Devices
Christa Jansen-Otten, West
9:45 The Complete Process to Manufacture Pre-filled SyringesFrom Washing to Packaging, Part I:• Machine and Equipment / Bulk and Ready to Use Concepts /
IPC / RABS and Isolators
Josef Veile, Groninger
10:45 Coffee Break
11:15 The Complete Process to Manufacture Pre-filled SyringesFrom Washing to Packaging, Part II:• Machine and Equipment / Bulk and Ready to Use Concepts /
IPC / RABS and Isolators
Josef Veile, Groninger
11:45 Silicone: “The Chemistry Behind It” / Chemical and Physical Aspects Patrizia Wenzel, Biesterfeld Spezialchemie
12:15 Lunch Break
13:15 Single-Use in Final Filling:• Process Design • Quality Considerations
Simone Biel, Merck Mllipore
14:00 A Comparision of Pre-filled Syringes Filling Operations in RABS and Isolators
M+P speaker
14:45 Coffee Break
15:15 Hands-On Training using Industry Equipment:• Silicone distribution (rap.ID)• Siliconization (Groninger)• Silicone chemical/physical aspects (Biesterfeld)• Single Use (Merck Millipore)• Filling (Groninger)
hands-on exercises
17:15 Q & A
17:45 End of Day 1
26 europe.pda.org/AnnualMeeting2016
Friday, 1 July 2016 9:00 – 16:30
9:00 Material, Manufacturing, Process and Quality Effects on Glass:• Polymers / Coating / Multilayer
Horst Koller, HK Packaging
9:45 Elastomeric Closures for Pre-filled Syringe and Cartridge Applications: • Manufacturing / Requirements / Coatings / Quality / Extractable /
Regulatory / Adopted Packaging
Christa Jansen-Otten, West
10:45 Coffee Break
11:15 Comparing Different Solutions on Nested Containers• BD / Gerresheimer / NIPRO / OMPI / Schott / West
Horst Koller, HK Packaging
11:45 Q&A on Nested Packaging Horst Koller, HK Packaging
12:00 Development and Regulatory Aspects of Primary Packaging Material: • Transfer from Vial into Syringe
Horst Koller, HK Packaging
13:00 Lunch Break
14:00 Hands-On:• Stoppering (Groninger)• Particle Identification (rap.ID)• Primary Packaging (West)• Packaging and Components (HK Packaging)
Practical Training provided by various suppliers
16:00 Open Discussion
16:30 End of Workshop
WORKSHOP AGENDA
27europe.pda.org/AnnualMeeting2016
20-21 September 2016 Radisson Blue es. Hotel
Rome | Italy
Register by 20 August 2016
and SAVE!
The Parenteral Drug Association presents:
2016 PDA Europe 9th Workshop on Monoclonal Antibodies
pda.org/EU/MAB2016
Ensuring mAbs’ Quality – Current Considerations for Control Strategy Design
22 September From Gene to Product – Tailormade Strategies for High Level Expression of Biologicals
22 September Elastomers
22-23 September CMC Regulatory Compliance for Biopharmaceuticals
22-23 September Extractables and Leachables
22-23 September Introduction to Aseptic Processing Principles
22-23 September Statistics of Production Monitoring and Capability
28 europe.pda.org/AnnualMeeting2016
INFORMATION
V E N U EEstrel BerlinSonnenallee 22512057 BerlinGermanyTel.: + 49 (0) 30 683 10Mail: hotel@estrel.comhttps://www.estrel.com/en/hotel.html
Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.
CO NTAC T I N FO R M ATI O NConference InquiriesMelanie DeckerDirector Events & Exhibitionsdecker@pda.org
Conference Program InquiriesSylvia BeckerManager Programs & Eventsbecker@pda.org
Registration & Customer CareTel: + 49 30 4365508-10registration-europe@pda.org
Education Program InquiriesElke von LaufenbergManager Training & Educationlaufenberg@pda.org
Exhibition/Sponsorship Inquiries Creixell Espilla-GilartManager Exhibition & Sponsorship espilla@pda.org
G E N E R A L A D D R E S SPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: + 49 30 4365508-0Fax: + 49 30 4365508-66info-europe@pda.org
CO N F E R E N C E R EG I S TR ATI O N H O U R SMonday, 27 June: 9:00 – 18:00Tuesday, 28 June: 8:00 – 18:00Wednesday, 29 June: 7:00 – 17:00
CO U R S E R EG I S TR ATI O N H O U R SThursday, 30 June: 8:00 – 16:30Friday, 01 July: 8:30 – 12:00
TO E X H I B ITExhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of high-ly-qualified, upper-level professionals in the pharmaceuti-cal and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees. Please see the Exhibition Floor Planorg go to: europe.pda.org/AnnualMeeting2016
S PEC I A L R EQU I R E M E NT SIf you require special accommodations to fully par- ticipate, please attach a written description of your
needs with your registration form. Specific questions can be directed to registration-europe@pda.org.
Special offer: Discounted travel with Lufthansa Group Airlines
Lufthansa Group Par tner Airlines of fer a comprehensive global route network linking major cities around the world. We offer spe-cial prices and conditions to par ticipants, visitors, exhibitors, in-vited guests as well as employees of the Contracting par tner and their travel companions. To make a reser vation, please click on www.lufthansa.com/event-booking_en and enter the access code DEZZYGX in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.
NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.
These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by send-ing an email to lufthansa.mobility@dlh.de and providing the access code as a reference.
https://goo.gl/maps/Q99HdV8HPf12
D I R EC TI O N S
© Google For directions click
on the picture, scan the QR-code or go to
29europe.pda.org/AnnualMeeting2016
Helpful Hints When Registering for PDA Europe Events
M A K I N G I T E A S I E R F O R B OT H O F U S
Registration cannot be completed by sending Purchase Order alone. A Purchase Order is only accepted if a complete registration form is enclosed or follows very soon.
4 Purchase Orders
1 Please include your member ID number on registration form if available/known
If uncertain about your member ID number and/or your membership status, call or email us.+49 (0)30 43 655 08-10 info-europe@pda.org
2 Do not send money in advance
Please wait until we send our invoice to you. It is helpful to reference our invoice number in your bank transfer details.
6 Please state the correct billing address on the registration form
This is particularly important if billing address and site address are different. Contact your accounting depart-ment for correct address and company name. There could be special requirements for accounting. Changes in the billing address (if induced by participating company) will be charged 25,- € if imposed 3 weeks prior to the start of the event.
9 Substitutions
If a participant is unable to attend, substitutions are welcome at any time. Changes are free of charge until 3 weeks prior to the start of the event. After this date, there will be a charge of € 50 per name change.
7 Confirmation of your registration
Credit card charges are confirmed immediately if successfully approved.Bank transfers are confirmed upon receipt of full payment.
8 Refund/Credit Notes
Refunds to credit card can be done immediately if payment had been done by credit card and details are available. Refunds to bank accounts can be done if payment had been done by bank transfer and the following details are provided: a) Name of your bank b) IBAN number c) Swift/BIC code
3 Complete and sign the event registration form
Please note the registration and cancellation policies at the bottom of the form.
5 Please state VAT ID number if European-based Company
This number starts by your country code(example: PDA Europe’s VAT ID number = DE254459362)
THANK YOU FOR YOUR COOPERATION!
30 europe.pda.org/AnnualMeeting2016
Registration Form − Page 1
PDA Europe Conference, Exhibition, Workshops, Training Courses
1st PDA Europe Annual Meeting28 June - 01 July | Berlin | Germany
Your registration is only complete upon filling in and submitting both pages of this form.
1 RegistrationNo PDA membership included
Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1295 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).
*Discount for Exhibiting Companies
30 June One-Day Training Course Training Course Fee netto
Test Methods for Pre-filled Syringe Systems All Participants 695
30 June One-Day Training Course Training Course Fee netto
How to Find the Right GMP for APIs All Participants 695
30 June One-Day Training Course Training Course Fee netto
Cleaning and Disinfection All Participants 695
30 June - 01 July Two-Day Training Course Training Course Fee netto
Root Cause Investigation All Participants 1395
30 June - 01 July Two-Day Workshop Workshop Fee netto
Development and Manufacturing of Pre-filled Syringes
All Participants 1495
Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact us at registration-europe@pda.org. Other discounts cannot be applied.
The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.
Book by 25 March 2016 and save! EARLY BIRD DISCOUNT
28-29 June Conference only Conference Fee By 25 March 2016 After 25 March 2016
1st PDA Europe Annual Meeting PDA Member 995 1595Nonmember 1645 1895
Regulatory / Academic 700 800Discount for Exhibiting Companies (see below)*
This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.
31europe.pda.org/AnnualMeeting2016
Date Mandatory Signature
Your registration is only complete upon filling in and submitting both pages of this form.
3 Payment Options
Billing Address: Same as contact information address above. If not, please send your billing address to: registration-europe@pda.org
By Bank Transfer Beneficiary: PDA Europe gGmbHIBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBERBank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany
By Credit Card (one week prior to event)
American Express MasterCard VISA
For your credit card information safety:Please send your details by fax only.
Purchase Order
Purchase Order Number
Job Title *
Mailing Address
Substituting for(Ch e ck only i f you are subs t i tut ing for a pre v iously e nrolle d colleag ue; a nonme mb e r subs t i tut ing for me mb e r mus t pay t h e me mb e r ship fe e.)
* This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us.
1 Your Contact Information
PDA MemberName (Last, First, MI) *
ID Number
Country Email *
FaxBusiness Phone
Company* Department
City Postal Code
If this form is an update to a previously submitted form, please check here.
Mr. Ms. Dr. NonmemberI want to become a PDA Member. Please send me a subsription form
• All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
• All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for sub-mitting documents by courier.)
• Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
2 Information about Visa Matters
CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. You must have a written confirmation (including invoice) to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. Payment must be received or guaranteed by Purchase Order or credit card details on 1st day of event, at the very latest. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 28 May 2016, you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at registration-europe@pda.org or fax to +49 30 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.
PDA Europe VAT I.D.: DE254459362Your Company VAT I.D.:
This number starts by your country code with two characters (example: PDA Europe’s country code starts with: DE | followed by the number)
Registration Form − Page 2
PDA Europe Conference, Exhibition, Workshops, Training Courses
1st PDA Europe Annual Meeting28 June - 01 July | Berlin | Germany
4 WAYS TO REGISTER
ONLINE: europe.pda.org/AnnualMeeting2016FAX: +49 30 4365508-66EMAIL: registration-europe@pda.org MAIL: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany
1234
This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.
www.europe.pda.org
General InformationPDA Europe gGmbHAm Borsigturm 60 13507 Berlin, GermanyTel: +49 30 4365508-0Fax: +49 30 4365508-66
Conference InformationMelanie DeckerDirector Events & ExhibitionsTel: + 49 30 4365508-19decker@pda.org
Training Course InformationElke von LaufenbergManager Training & EducationTel: + 49 30 4365508-21laufenberg@pda.org
LegendIG – Interest Group MeetingTC – Training CourseWS – Workshop
2 0 1 6 P D A E U R O P E A C T I V I T I E S & E V E N T S 31 May - 1 June
Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision
WS Berlin, Germany
6 June7-8 June9 June9 June
Viral Safety of ATMPs | Conference Advanced Therapy Medicinal Products | ConferencePractical Application of GMP for Development of ATMPsVirus Filtration
TCTC
Berlin, Germany
28-29 June30 June30 June30 June30 June - 1 July30 June - 1 July
1st PDA Europe Annual MeetingTest Methods for Pre-filled Syringe SystemsCleaning and Disinfection How to Find the Right GMP for APIsRoot Cause Investigation Development and Manufacturing of Pre-filled Syringes
TCTCTCTCWS
Berlin, Germany
20-21 September22 September22 September22-23 September22-23 September22-23 September22-23 September
9th Workshop on Monoclonal AntibodiesElastomersRecombinant Proteins: From Gene to Product CMC Regulatory Compliance for BiopharmaceuticalsExtractables and LeachablesIntroduction to Aseptic Processing PrinciplesStatistics of Production Monitoring and Capability
TCTCTCTCTC
Rome, Italy
27-28 September29 September29-30 September
Pharmaceutical Freeze Drying Technology | ConferenceApplication of a Risk-Based Approach to Freeze-Drying ProcessesDevelopment of a Freeze Drying Process
TCWS
Strasbourg, France
5-6 OctoberCurrent Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision
WS Dublin, Ireland
10 October11-12 October13-14 October
Interest Group Meeting Pharmaceutical Cold ChainPharmaceutical Cold & Supply Chain LogisticsGood Cold Chain Practices
IG
WS
Amsterdam, The Netherlands
24 October25-26 October27-28 October
Particle Identification in Parenterals Visual Inspection ForumAn Introduction to Visual Inspection: A Hands-on Course
TC
TCBerlin, Germany
8-9 November Data Integrity WS Berlin, Germany
14 November15-16 November17 November17-18 November
Risk-based Approach for Prevention and Management of Drug ShortagesOutsourcing & Contract Manufacturing | ConferenceQuality by Design for BiopharmaceuticalsRoot Cause Investigation
TC
TCTC
Barcelona, Spain
Subject to change For latest info: europe.pda.org Shortlist 27 May 2016