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Pharmacopoeia Conference

May 16 - May 17, 2019
Geneva, Switzerland

The 2nd Annual PDA Conference on International Developments in the Pharmacopoeial Landscape

  • Conference
  • Europe
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Program Highlights

Final Agenda Published!

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Overview

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

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Agenda

  • Day 1
  • Day 2

  • 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

  • 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

Highlighted Speakers

Tsuyoshi Ando
Tsuyoshi Ando
PMDA, Japanese Pharmacopeia
Kevin Carrick
Kevin Carrick
United States Pharmacopoeia
Sabine Kopp
Sabine Kopp
World Health Organization
Riviane Matos Gonçalves
Riviane Matos Gonçalves
Brazilian Health Regulatory Agency
Sandra Prior
Sandra Prior
NIBSC
Andrew Rutter
Andrew Rutter
GSK
Jaap Venema
Jaap Venema
United States Pharmacopoeia (USP)
Cathie Vielle
Cathie Vielle
EDQM
View All

Additional Information

  • Who Should Attend

    More information coming soon.

Got a Question? We have answers

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Travel

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
Phone: +41 (0) 22 710 30 29

Crowne Plaza Geneva
  • Accommodations

    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)
  • Amenities

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.

Other Options

Free shuttle bus between airport and hotel.

Train station: Cointrin.

Subway station: De Joinville bus stop.

Directions

Registration Fees

Early Registration
Registration Type Price by 17 March
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €750















Regular Registration
Registration Type Price after 17 March
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €850

All fees given in Euro and excluding VAT (21%)
















Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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