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2019 Pharmacopoeia

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

First Agenda Published!

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

Call for Abstracts

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

Agenda

  • Day 1
  • Day 2
  • Thursday, 16 May 2019

    9:00 – 9:15
    Welcome and Introduction
    Falk Klar, PDA Europe
    Susanne Keitel, EDQM
    Nadine Ritter, Global Biotech Experts

    9:15 – 13:00
    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


    Chinese Pharmacopoeia

    10:30 –11:00
    Coffee Break, Poster Session & Exhibition

    ANVISA,
    Brazil


    Indian Pharmacopoeia Commission,
    IPC


    World Health Organization,
    WHO

    13:00 –14:00
    Lunch Break, Poster Session & Exhibition

    14:00 – 15:30
    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.

    Analytical QbD and the Pharmacopoeia
    British Pharmacopoeia / MHRA


    Evolution of the Compendial Landscape – Product Specific Monographs for Biotherapeutics
    EDQM


    Evolution of an Organization Sparked by the Changing Compendial Landscape
    Janssen J&J


    Manufacturing Landscape
    GSK on behalf of EFPIA

    15:30 –16:00
    Coffee Break, Poster Session & Exhibition

    16:00 – 17:00
    Breakout & Roundtables

    ANALYTICS
    Interchangeability and Validation of Analytical Methods, Acceptance Criteria, QbD, etc.


    BIOTHERAPEUTICS
    ATMPs, Monoclonal Antibodies, Biosimilars / Biobetters, etc.


    MANUFACTURING
    Continuous Manufacturing, PAT, Control of Impurities, etc.

    17:00 – 18:30
    Summary and Closing of Day 1

    18:30
    Networking Dinner in Geneva

    Friday, 17 May 2019

    9:00 – 9:30
    Summary of Day 1: Take-Aways, Learnings from Regulatory and Industry Perspectives

    TRANSITION TO PARALLEL TRACKS

    9:30 – 12:30
    Session 3A: REFERENCE STANDARDS – MANUFACTURE AND CHARACTERIZATION

    Use of Compendial Reference Standards for Instrument Qualification and Method Validation
    EDQM


    USP

    10:30 –11:00
    Coffee Break, Poster Session & Exhibition

    NIBSC


    Industry Speaker
    invited

    9:30 – 12:30
    Session 3B: PRACTICAL EXAMPLES OF MONITORING, ASSESSMENT AND IMPLEMENTATION OF PHARMACOPOEIAL CHANGES

    Case Study: A Process for Monitoring and Engaging with Pharmacopoeias
    Biogen


    Compendial Compliance in a Global Environment & Global Process of Compendial Review
    Global Pharmacopoeia Solutions

    10:30 –11:00
    Coffee Break, Poster Session & Exhibition

    Control Strategy for Particulate Matter in Biopharmaceutical Drug Products - an Industry Perspective
    Hoffmann – La Roche


    A Case Study: Different Pharmacopoeial Standards
    Novo Nordisk

    12:30 –13:30
    Lunch Break, Poster Session & Exhibition

    13:30 – 16:30
    Session 4: Process for Prioritization in Convergence of Monographs and Maintenance of Convergent Status

    Update on Recent PDG Developments and the New Maintenance Procedure on the ICH Q4B Annexes Adopted by the ICH Assembly
    EDQM


    Bilateral Working Principles: Harmonization Efforts
    EFPIA Speaker, invited

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

    Joint Reflection from Pharmacopoeia & Industry
    EDQM & Pfizer

    16:30
    Summary & End of Conference

  • Friday, 17 May 2019

    9:00 – 9:30
    Summary of Day 1: Take-Aways, Learnings from Regulatory and Industry Perspectives

    TRANSITION TO PARALLEL TRACKS

    9:30 – 12:30
    Session 3A: REFERENCE STANDARDS – MANUFACTURE AND CHARACTERIZATION

    Use of Compendial Reference Standards for Instrument Qualification and Method Validation
    EDQM


    USP

    10:30 –11:00
    Coffee Break, Poster Session & Exhibition

    NIBSC


    Industry Speaker
    invited

    9:30 – 12:30
    Session 3B: PRACTICAL EXAMPLES OF MONITORING, ASSESSMENT AND IMPLEMENTATION OF PHARMACOPOEIAL CHANGES

    Case Study: A Process for Monitoring and Engaging with Pharmacopoeias
    Biogen


    Compendial Compliance in a Global Environment & Global Process of Compendial Review
    Global Pharmacopoeia Solutions

    10:30 –11:00
    Coffee Break, Poster Session & Exhibition

    Control Strategy for Particulate Matter in Biopharmaceutical Drug Products - an Industry Perspective
    Hoffmann – La Roche


    A Case Study: Different Pharmacopoeial Standards
    Novo Nordisk

    12:30 –13:30
    Lunch Break, Poster Session & Exhibition

    13:30 – 16:30
    Session 4: Process for Prioritization in Convergence of Monographs and Maintenance of Convergent Status

    Update on Recent PDG Developments and the New Maintenance Procedure on the ICH Q4B Annexes Adopted by the ICH Assembly
    EDQM


    Bilateral Working Principles: Harmonization Efforts
    EFPIA Speaker, invited

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

    Joint Reflection from Pharmacopoeia & Industry
    EDQM & Pfizer

    16:30
    Summary & End of Conference

Additional Information

  • Call for Abstracts

    Call for Abstracts is available now!!

    Download Call for Papers

    Call for Papers/Abstracts is available now.

    Download

    Abstract Submission

    Call for Papers/Abstracts is available now.

    Submit Abstract
  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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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

Make a Reservation
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%)

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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