2019 pda europe pharmacopoeia - edqm · 14:00 analytical qbd and the pharmacopoeia british...
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2019 PDA EUROPE
Pharmacopoeia The 2nd Annual PDA Conference onInternational Developments in the Pharmacopoeial Landscape
16-17 MAY 2019 GENEVA, SWITZERLAND
EXHIBITION: 16-17 MAY 2019
pda.org/EU/pharma2019
CONNECTINGPEOPLE SCIENCE AND
REGULATION®
2 pda.org/EU/pharma2019
Susanne Keitel, PhD, EDQM, Chair
Nadine Ritter, PhD, Global Biotech Experts, Co-Chair
LETTER FROM THE CHAIRS
SCIENTIFIC PROGRAM PLANNING COMMITTEE
Susanne Keitel, Chair, EDQM
Nadine Ritter, Co-Chair, Global Biotech Experts
Vinny Browning III, Amgen
Graham Cook, Pfizer
Frithjof Holtz, Merck KGaA
Ruth Miller, PDA
Janeen Skutnik-Wilkinson, Biogen
Paolo Tozzi, Novartis
Falk Klar, PDA Europe
Sylvia Becker, PDA Europe, Senior Manager Programs & Events
Dear Colleagues,
At the 2018 inaugural conference, representatives from globally recognized pharmacopoeias shared their authorities' and organisations’ approaches to international convergence, harmo nization & the future direction of pharmacopoeias with respect to the overall framework of regulations and guidelines. This resulted in valuable discussion and exchange and generated momentum we now intend to use and continue our efforts to delve deeper into issues relevant to manufacturers of active pharmaceutical ingredients, excipients and medicinal products.
Once again, we kindly invite you to contribute your professional insights, views and best-practices in the effective and efficient implementation of international pharmacopoeial requirements.
See you in Geneva!
3pda.org/EU/pharma2019
WELCOME TO GENEVA
S C H E D U L E A T A G L A N C E
16 May 9:00 – 18:00 Pharmacopoeia Conference, Exhibition
16 May 18:30 – 21:30 Networking Reception
17 May 9:00 – 16:30 Pharmacopoeia Conference, Exhibition
For latest information, please visit: pda.org/EU/pharma2019
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CONFERENCE AGENDA
4 Apr 2019
Thursday, 16 May 2019
9:00 Welcome and Introduction Falk Klar, PhD, PDA EuropeSusanne Keitel, PhD, EDQM, Conference Chair Nadine Ritter, PhD, Global Biotech Experts, Conference Co-Chair
Session 1: Working Principles of Pharmacopoeias in Their Regulatory Framework
In this opening session, invited international representatives will share specifics with respect to • Legal Status • Governing Bodies • Decision-making • Methods & Tech Transfer: Minimum Requirements from a Pharmacopoeial Perspective • Acceptance of Alternative Methods / Definition of Alternative Methods
European Directorate for the Quality of Medicines and HealthCare, EDQM
United States Pharmacopoeia, USP
Pharmaceuticals and Medical Devices Agency, PMDA, Japan
10:30 Coffee Break, Poster Session & Exhibition
ANVISA, Brazil
Indian Pharmacopoeia Commission, IPC
World Health Organization, WHO
13:00 Lunch Break, Poster Session & Exhibition
Session 2: Introduction to Breakout Session
This session will set the stage for the afternoon roundtable discussions by providing overviews, summaries and current key issues of each of the three main featured topics.
14:00 Analytical QbD and the Pharmacopoeia British Pharmacopoeia / MHRA
Evolution of the Compendial Landscape – Product Specific Monographs for Biotherapeutics
EDQM & Janssen J&J
Continuous Manufacture of Drug Products and Drug Substances GSK & Pfizer on behalf of EFPIA
15:30 Coffee Break, Poster Session & Exhibition
Breakout & Roundtables16:00 ANALYTICS BIOTHERAPEUTICS MANUFACTURING
Interchangeability and Validation of Analytical Methods,
Acceptance Criteria, QbD, etc.
ATMPs, Monoclonal Antibodies, Biosimilars / Biobetters, etc.
Continuous Manufacturing, PAT, Control of Impurities, etc.
17:00 Summary and Closing of Day 1
18:30 Networking Reception in Geneva
5pda.org/EU/pharma2019
CONFERENCE AGENDA
Friday, 17 May 2019
PA R A L L E L T R A C K S
Session 3 TRACK A TRACK B
REFERENCE STANDARDS – MANUFACTURE AND CHARACTERIZATION
PRACTICAL EXAMPLES OF MONITORING, ASSESSMENT AND IMPLEMENTATION OF
PHARMACOPOEIAL CHANGES
9:00 Use of Compendial Reference Standards for Instrument Qualification and Method Validation
EDQM
Case Study: A Process for Monitoring and Engaging with Pharmacopoeias
Biogen
Latest Developments in USP Biologics Performance Standards
USP
Compendial Compliance in a Global Environment & Global Process of Compendial Review
Global Pharmacopoeia Solutions
10:00 Coffee Break, Poster Session & Exhibition
Bioassay International Standards for Monoclonal Antibodies: New Reagents for New Challenges
NIBSC
Control Strategy for Particulate Matter in Bio-pharmaceutical Drug Products - an Industry
PerspectiveHoffmann – La Roche
Compendial Equivalence of In-house Reference Standards - Learnings and Key Challenges of the
ProcessNovartis
Challenges and Potential Risk of Not Having Harmonized Pharmacopeia Require-
ment: A Case StudyNovo Nordisk
11:30 Q&A, Discussion
12:00 Lunch Break, Poster Session & Exhibition
Session 4: Process for Prioritization in Convergence of Monographs and Maintenance of Convergent Status
13:00 Update on Recent PDG Developments and the New Maintenance Procedure on the ICH Q4B Annexes Adopted by the ICH Assembly
EDQM
Bilateral Working Principles: Pharmacopoeial Harmonization Novartis on behalf of EFPIA
An Effective Process for Monitoring, Assessing, and Implementing Compendial Changes at a Global Pharmaceutical Company
Eli Lilly
Q&A, Closing Panel Discussion
15:00 Coffee Break, Poster Session & Exhibition
Closing Keynote – Joint Reflection from Pharmacopoeia & Industry EDQM & Pfizer
16:30 Summary & End of Conference
Draft Program, all details subject to change without prior notice.
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FLOOR PLAN
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TO EXHIBIT
PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibition and Sponsorship Opportunities are available. A basic exhibition package for this event is priced 1.995 Euro net (table-top). For more information please contact [email protected]
25-26 JUNE 2019 AMSTERDAM, THE NETHERLANDS
EXHIBITION: 25-26 JUNE
pda.org/EU/Annual2019
Global Healthcare of the Present and the Future
4th PDA EuropeAnnual Meeting
REGISTER BEFORE 28 APRIL AND SAVE UP TO €200!
25-26 JUNE 2019 AMSTERDAM, THE NETHERLANDS
EXHIBITION: 25-26 JUNE
pda.org/EU/Annual2019
Global Healthcare of the Present and the Future
4th PDA EuropeAnnual Meeting
REGISTER BEFORE 28 APRIL AND SAVE UP TO €200!
INFORMATION
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VENUECrowne Plaza GenevaAvenue Louis Casai 75-77 1216 Geneva SwitzerlandHousing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.
CONTACT INFORMATIONConference/Exhibition/Sponsorship InquiriesMelanie DeckerDirector Events & [email protected]
Conference Program Inquiries Sylvia Becker [email protected] Customer Care Tel: +49 30 4365508-10 [email protected]
GENERAL ADDRESSPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: +49 30 4365508-0Fax: +49 30 4365508-66
CONFERENCE REGISTRATION HOURSThursday, 16 May: 8:30 – 18:00Friday, 17 May: 8:30 – 15:00
TO EXHIBIT:Exhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly- qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees.
SPECIAL REQUIREMENTSIf you require special accommodations to fully participate, please attach a written description of
your needs with your registration form. Specific questions can be directed to [email protected].
DIRECTIONS
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These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by sending an email to [email protected] and providing the access code as a reference.
PDA Europe Supports the Children's Hospice „Sonnenhof”BUY A PACKAGE OF CHEWING GUMS AT THE
REGISTRATION DESK. THANK YOU!
To know more about the Sonnenhof Hospice, please visit www.bjoern-schulz-stiftung.de
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online: pda.org/EU/pharma2019FAX: +49 30 4365508-66Email: [email protected]
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The fee includes course documentation as well as mid-session refreshments and lunch. Excellent net-working opportunities with snacks and drinks will be given. The fee does not include the hotel accommo-dation. PDA Europe has secured a limited number of rooms at a special group rate.
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15-17 May 2019 | Geneva | Switzerland
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Pharmacopoeia Conference
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16-17 May Pharmacopoeia Geneva, Switzerland
22-24 May24 May
Visual Inspection Week Interest Group Meeting Visual Inspection Berlin, Germany
4-5 June Advanced Therapy Medicinal Products Vilnius, Lithuania
24 June 24 June25-26 June
Workshop: The Digital Robot Pharma FabInterest Group Meeting Quality Systems4th PDA Europe Annual Meeting
Amsterdam, The Netherlands
2 September2 September3-4 September
Interest Group Meeting Freeze DryingInterest Group Meeting Technology Transfer BioManufacturing
Munich, Germany
5 September Project Management in the Pharmaceutical Industry Munich, Germany
24-25 September Pharmaceutical Freeze Drying Technology Berlin, Germany
24-25 September Particles in Injectables Berlin, Germany
21 October21 October21 October22-23 October
Workshops:Impact of Pre-fi lled Syringe Components on BiopharmaceuticalsInnovating the Journey from Manufacturing to the PatientInnovative Drug Delivery Systems/Combination ProductsThe Universe of Pre-fi lled Syringes and Injection Devices
Gothenburg, Sweden
12-13 November Pharma Logistics & Outsourced Operations Lisbon, Portugal
Subject to change For latest info: europe.pda.org Shortlist 4 Apr 2019
CONNECTINGPEOPLE SCIENCE AND
REGULATION®
europe.pda.org
GENERAL INFORMATIONPDA EUROPE GGMBHAM BORSIGTURM 60
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FAX: +49 30 [email protected]
P DA E U R O P E E V E N T S