Pharmacopoeia Conference

Geneva, Switzerland
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Program Highlights

Final Agenda Published!

Review the updated brochure and make sure to be part of this program!

Dear Colleagues,

At the 2018 inaugural conference, representatives from globally recognized pharmacopoeias shared their authorities' and organisations’ approaches to international convergence, harmonization & 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.

Please be invited to submit a paper or poster abstract for presentation and contribute your professional insights, views and best-practices in the effective and efficient implementation of international pharmacopoeial requirements.

We look forward to welcoming you to beautiful Geneva, Switzerland next May!

Best Regards,

Susanne Keitel,
PhD, EDQM, Chair

Nadine Ritter,
PhD, Global Biotech Experts, Co-Chair

Event Location
Crowne Plaza Geneva
Avenue Louis Casai 75-77, Geneva, Switzerland Get Directions

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
[email protected]
Registration Customer Care

Standard Pricing

Standard Member Price

€1.895

GovernmentMember Only

€850

Health AuthorityMember Only

€850

AcademicMember Only

€850

Non-Member

€2.195

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Thursday, 16 May 2019

9:00 – 9:10
Welcome and Introduction
Falk Klar, PDA Europe
Susanne Keitel, EDQM,Conference Chair
Nadine Ritter, Global Biotech Experts, Conference Co-Chair

9:10 – 13:15
Session 1: Working Principles of Pharmacopoeias in Their Regulatory Framework
Moderators:
Nadine Ritter, Global Biotech Experts
Janeen Skutnik-Wilkinson, Biogen

9:10 – 9:40
The Ph. Eur.: A Successful Example of How a Pharmacopoeia Supports and Fosters Implementation of Regulatory Texts
Susanne Keitel, EDQM

9:40 – 10:10
Ensuring Quality of Medicines: Role of USP Standards
Jaap Venema, USP

10:10 – 10:40
Japanese Pharmacopoeia
Tsuyoshi Ando, PMDA

10:40 –11:10
Coffee Break, Poster Session & Exhibition

11:10 – 11:40
Brazilian Pharmacopoeia:
Working Principles and regulatory Framework
Riviane Matos Gonçalves, ANVISA

11:40 – 12:10
Place and Role of the Indian Pharmacopoeia Commission in
Promoting Quality and Safety of Medicines
Manisha Trivedi, IPC

12:10 – 12:40
WHO Updates: International Perspective
Sabine Kopp, WHO

12:40 – 13:15
Panel Discussion with International Representatives

13:15 –14:15 
Lunch Break, Poster Session & Exhibition

14:15 – 16:00
Session 2: Introductions to Breakout Session
Moderator: Susanne Keitel, EDQM

Each of these talks will introduce the audience to the three topics Analytics, Biotherapeutics, and Manufacturing before each of these will be addressed in more detail during the afternoon roundtable discussions.

14:15 – 14:45
Analytical QbD and the Pharmacopoeia
James Pound, MHRA

14:45 – 15:15
Evolution of the Compendial Landscape – Product Specific Monographs for Biotherapeutics
Mihaela Buda, EDQM
Joseph A. Albanese, Janssen, J&J

15:15 – 15:45
Continuous Manufacture of Drug Products and Drug Substances
Andrew Rutter, GSK
Graham Cook, Pfizer on behalf of EFPIA

15:45 – 16:15 
Coffee Break, Poster Session & Exhibition

16:15 – 17:45
Breakout Sessions – Roundtable Discussions

Attendees are free to choose two out of the three topics offered, engaging in discussions for 45 minutes each.

Analytics
Moderators:
James Pound, MHRA
Vinny Browning, Amgen
Interchangeability and Validation of Analytical Methods, Acceptance Criteria, QbD, etc

Biotherapeutics
Moderators:
Nadine Ritter, Global Biotech Experts
Mihaela Buda, EDQM
ATMPs, Monoclonal Antibodies, Biosimilars / Biobetters, etc.

Manufacturing
Moderators:
Graham Cook, Pfizer
Cathie Vielle, EDQM
Continuous Manufacturing, PAT, Control of Impurities, etc.

17:45
Brief Summary of Highlights from Roundtables

18:00
End of Day 1 and Networking Event

Day 2

Friday, 17 May 2019

TRANSITION TO PARALLEL TRACKS

9:00 – 12:00
Session 3A: Reference Standards – Manufacture and Characterization
Moderator: Vinny Browning, Amgen

9:00 – 9:30
Use of Compendial Reference Standards for Instrument Qualification and Method Validation
Stefan Almeling, EDQM

9:30 – 10:00
Latest Developments in USP Biologics Performance Standards
Kevin Carrick, USP

10:00 – 10:30
Coffee Break, Poster Session & Exhibition

10:30 – 11:00
Bioassay International Standards for Monoclonal Antibodies: New Reagents for New Challenges
Sandra Prior, NIBSC

11:00 – 11:30
Compendial Equivalence of In-house Reference Standards - Learnings and Key Challenges of the Process
Aoife Mee, Novartis

11:30 – 12:00
Q&A, Discussion

9:00 – 12:00
Session 3B: Practical Examples of Monitoring, Assessment and Implementation of Pharmacopoeial Changes
Moderator: Frithjof Holtz, Merck

9:00 – 9:30
Case Study: A Process for Monitoring and Engaging with Pharmacopoeias
Janeen Skutnik Wilkinson, Biogen

9:30 – 10:00
Compendial Compliance in a Global Environment: Process Optimization for Pharmacopoeia Review
J. Mark Wiggins, Global Pharmacopoeia Solutions

10:00 – 10:30
Coffee Break, Poster Session & Exhibition

10:30 – 11:00
Case Study of Particulate Matter in Biopharmaceutical Drug Products – Leveraging Working Groups and White Papers
Jan Stracke, Hoffmann-La Roche

11:00 –12:00
Q&A, Panel Discussion

12:00 – 13:00
Lunch Break, Poster Session & Exhibition

13:00 – 16:30
Session 4: Process for Prioritization in Convergence of Monographs and Maintenance of Convergent Status
Moerator: Paolo Tozzi, Novartis

13:00 – 13:30
An Effective Process for Monitoring, Assessing, and Implementing Compendial Changes at a Global Pharmaceutical Company
Matthew Borer, Eli Lilly

13:30 – 14:00
Bilateral Working Principles: Harmonization Efforts
Philip Travis, Pfizer on behalf of EFPIA

14:00 – 14:30
Update on Recent PDG Developments and the New Maintenance Procedure on the ICH Q4B Annexes Adopted by the ICH Assembly
Cathie Vielle, EDQM

14:30 – 15:00
Q&A, Panel Discussion

15:00 – 15:30
Lunch Break, Poster Session & Exhibition

15:30 – 16:00
Closing Keynote – Overview, Future Perspectives
Joint Reflection from Pharmacopoeia & Industry
Susanne Keitel, EDQM
Graham Cook, Pfizer

16:00 – 16:30
Closing Remarks
Susanne Keitel, EDQM,Conference Chair
Nadine Ritter, Global Biotech Experts, Conference Co-Chair
Falk Klar, PDA Europe

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Crowne Plaza Geneva

Avenue Louis Casai 75-77
Geneva, Switzerland , Crowne Plaza Geneva

+41 (0) 22 710 30 29

Hotel Website

Renovated and re-designed in 2014, the Crowne Plaza Geneva is within a 3-minute drive of Geneva Airport and the Palexpo Exhibition Center, and only a 10-minute drive from the city center. The hotel offers a free shuttle service from and to the airport.

The hotel, with a Club floor on the top floor, offering panoramic views of the surroundings also offers its guests a complimentary breakfast, refreshments, snacks and a large selection of newspapers and books.

A bus stop and a taxi stand are right in front of the hotel. A free card for public transport is available at the reception. The hotel is only a 4-minute drive from the Balexert, Geneva's largest shopping mall.

PDA Europe has reserved a limited number of rooms until the 5th April 2019.
Book Your Room for the PDA Group Rate

Single Room CHF 235 per night, VAT, Taxes and Service Charges will apply*
Double Room CHF 265 per night, VAT, Taxes and Service Charges will apply*

*Rates are per room and night, including the following:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
How to Get Here
By Air

Nearest Airport: Geneva Airport - GVA, known as Cointrin Airport
Airport Phone: +41 22 717 71 11

By Car

1.4 km, 3 min by car. The Crowne Plaza Geneva is located at Avenue Louis Casai 75-77, Geneva 1216.