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2020Pharmacopeia-1988x680

2020 PDA Pharmacopeia Conference

Sep 29 - Oct 01, 2020
Eastern Standard Time | Online
  • Virtual
  • Conference
  • Online
  • The Americas

Overview

Pharmacopeias have a well-established history to help protect and improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines. This mission is shared by many stakeholders to the pharmacopeias, including regulatory agencies and the bio/pharmaceutical industry. There are several examples of collaborative responses to address issues relating to the quality of medicines, including control of contamination in glycerin, heparin, and – more recently – nitrosamines in “sartans”.

The global COVID-19 pandemic has challenged traditional approaches to nearly every aspect of life, including the manufacture, delivery, and development of new and existing medicines. The 2020 PDA Pharmacopeia Conference will explore the intersection of global pharmacopeias, regulators, and industry in responding to such crises. Join us virtually to discuss the roles of the pharmacopeias and various stakeholders in maintaining the drug supply, developing new treatments, and explore lessons learned to help address future health crises appropriately.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Day 4
  • Pre-Recorded Sessions

    Of Pharmacopeias and Pandemics: Setting the Stage
    Moderators: Kevin T. Moore, PhD,
    Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
    J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

    Pharmacopeias have a well-established history to help protect and improve the health of people around the world. But the global COVID-19 pandemic has challenged traditional approaches to nearly every aspect of life, including the manufacture, delivery, and development of new and existing medicines. What is the intersection of this public health crisis and the work of pharmacopoeias and stakeholders? This session will provide context for the overall conference, with pre-recorded presentations from the co-chairs and by some of those who have been impacted, including a pharmacist who contracted COVID-19 and a patient advocacy group representative.

    Welcome and Opening Remarks from Conference Co-Chair
    J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

    From the Ski Slopes to the ICU: My COVID-19 Journey
    Marilyn R. Stebbins, PharmD,
    Professor of Clinical Pharmacy and Vice Chair of Clinical Innovation, University of California, San Francisco, School of Pharmacy

    Patients' Perspectives
    Pam G. Traxel,
    Senior Vice President, American Cancer Society Cancer Action Network, Inc.

    Conference Lead-in from Conference Co-Chair
    Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia

  • Tuesday, September 29

    10:00 a.m. - 2:30 p.m. | Maintaining Drug Supply During the Pandemic: The Role of the Pharmacopeia and Standards
    Moderators: James Pound, BSc, Group Manager British Pharmacopoeia & Laboratory Services, MHRA and
    Erin G. Wang, MS, Associate Senior Consultant, Eli Lilly and Company

    Ensuring the timely and assured supply of medicines to patients is absolutely critical to the global healthcare response to the pandemic. Any interruption to supply could have serious consequences, whether for existing therapeutics in clinical trials for the treatment of COVID-19, medicines needed to support seriously ill patients in hospitals or consumer healthcare products. This session will consider the complex and challenging experiences of the pharmacopeias and industry stakeholders supporting the continued supply of medicines. For example, maintaining the supply of reference standards and the role of standards in supporting a supply chain under stress for both licensed and unlicensed medicines. With speakers from across the world, this will be a unique opportunity to learn how pharmacopeias, regulators and industry have responded and share your experiences and opinions.

    10:00 a.m. – 10:05 a.m. | Welcome and Recap of Pre-Recorded Sessions
    Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
    J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

    10:05 a.m. – 10:10 a.m. | Framework for the Session
    James Pound, BSc, Group Manager British Pharmacopoeia & Laboratory Services MHRA and
    Erin G. Wang, MS, Associate Senior Consultant, Compendial Affairs, Eli Lilly and Company

    10:10 a.m. – 10:40 a.m. | USP's Pandemic Response: Helping Ensure the Supply of Quality Medicines
    Ronald T. Piervincenzi, PhD,
    Chief Executive Officer, United States Pharmacopeia

    10:40 a.m. – 11:00 a.m. | Drug Shortages: A Creative - Disruptive - Transformative Solution Is Required
    Martin G. VanTrieste, BS Pharmacy, President & CEO, Civica Inc.

    11:00 a.m. – 11:20 a.m. | Systems Thinking, Pandemics, and Pharmacopoeias
    Alistair Gibb, PhD, Editor-in-Chief British Pharmacopoeia, Medicines and Healthcare products Regulatory Agency

    11:20 a.m. – 11:40 a.m. |Overview of NIFDC and Support for Regulation
    Mingzhe Xu, PhD, Deputy Director, Institute for Chemical Drug Control, China National Institutes for Food and Drug Control (NIFDC)

    11:40 a.m. – 12:00 p.m. | Q&A

    12:00 p.m. – 12:30 p.m. | Break

    12:30 p.m. – 12:50 p.m. | The European Paediatric Formulatry
    Dirk Leutner,
    Head of Pharmaceutical Technology Section, EDQM, Council of Europe

    12:50 p.m. – 1:10 p.m. | USP Compounding Standards
    Brian Serumaga, PhD, RPh,
    Senior Manager, Personalized Medicines, United States Pharmacopeia

    1:10 p.m. – 1:30 p.m. | Pharmaceutical Industry Reference Standards - Disaster Planning
    Matthew W. Borer, PhD,
    Senior Research Advisor, Eli Lilly and Company

    1:30 p.m. – 1:50 p.m. | Japanese Efforts to Ensure Supply of Basic Pharmaceuticals and the Role of Pharmacopoeia
    Shigeki Tsuda, MS,
    Senior Managing Director, Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ)

    1:50 p.m. – 2:10 p.m. | Overview of the Chinese Pharmacopoeia 2020 Edition
    Zonghua Song, PhD,
    Deputy Director, Chinese Pharmacopoeia Commission

    2:10 p.m. – 2:30 p.m. | Q&A

  • Wednesday, September 30

    10:00 a.m. – 1:30 p.m. | Developing New Treatments: The Role of the Pharmacopeia and Standards
    Moderators: Joseph A. Albanese, PhD, Director of Analytical Strategy and Compliance, Janssen Pharmaceuticals R&D, LLC (Johnson and Johnson) and
    Cathie Vielle, Head of the Pharmacopeia Europe Department, EDQM Council of Europe

    In such unprecedented pandemic situation, all those involved in ensuring that safe and appropriate medicines reached the patient faced new challenges. For example, most of the COVID-19 candidate vaccines developers are small or medium sized enterprises or universities with little or even no knowledge of the regulatory landscape (including Pharmacopeias). Additionally, new, and sometime controversial information about possible COVID-19 treatments using already existing therapies such as remdesivir, hydroxychloroquine, dexamethasone, Interferon β and others were published (e.g. in the media).

    This session will give the floor to speakers from different areas (Regulators, Pharmacopoeias, Industry) who will share how they approached this situation to best meet their duties: protection of Public Health and providing the best available treatment to patients in the shortest time possible.

    10:00 a.m. – 10:05 a.m. | Recap of Tuesday's Session
    Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
    J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

    10:05 a.m. – 10:10 a.m. | Framework for the Session
    Joseph A. Albanese, PhD, Director of Analytical Strategy and Compliance, Janssen Pharmaceuticals R&D, LLC (Johnson and Johnson) and
    Cathie Vielle, Head of the Pharmacopeia Europe Department, EDQM Council of Europe

    10:10 a.m. – 10:30 a.m. | USP Biologics Vaccine Strategy: Our Approach to Standards and Protecting the Public Health
    Sarita K. Acharya, MS,
    Science & Standards Liaison, United States Pharmacopeia

    10:30 a.m. – 10:50 a.m. | Rapid Response to COVID-19: The Role of CEPI in Vaccine Development
    Svein R. Andersen, Dr. Sci., Head of Regulatory Affairs - Europe, Europe Coalition for Epidemic Preparedness Innovation (CEPI)

    10:50 a.m. – 11:10 a.m. | Impact of Excipients in Vaccines: Material Qualification and Sourcing Issues for Janssen Vaccines
    John Schafer,
    Senior Scientist, Janssen

    11:10 a.m.  – 11:30 a.m. | Vaccines Q&A

    11:30 a.m. – 12:00 p.m. | Break

    12:00 p.m. – 12:20 p.m. | Monograph Availability of COVID-19 Investigated Drugs in World Pharmacopeias
    Diana C. Kwan, PharmD,
    Scientific Liaison, United States Pharmacopeia

    12:20 p.m. – 12:40 p.m. | Azithromycin: Compatibility and Simulated Dosing with Feeding Tubes
    Kimber L. Barnett, PhD,
    Research Fellow, Pfizer Inc.

    12:40 p.m. – 1:00 p.m. | Standards to Support the Development of New Treatments for COVID-19
    Christian K. Schneider, MD, Chief Scientific Officer, Medicines and Healthcare products Regulatory Agency

    1:00 p.m. – 1:30 p.m. | New Therapeutics and Regulatory View Q&A with Panelist
    Chris J. Burns, PhD, Head of Biotherapeutics Division, National Institute for Biological Standards and Control

  • Thursday, October 1

    10:00 a.m. – 11:30 a.m. | Maintaining Transparent Communication in Digitally Overloaded Times
    Moderators: Bettine Boltres, PhD, Principal Scientific Affairs, West Pharmaceutical Services and
    Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia

    With increasing digitalization there is also an increasing challenge of filtering this overload of information, assessing its accuracy, and determining appropriate action. Recent examples are therapeutic and vaccine development for COVID-19, as well as reported glass container shortages. Other examples include contamination concerns: nitrosamines, heparin, and glycerin. You will have a chance to hear from experts, ask questions, and provide your own experience on these important topics.

    This interactive session will explore two broad areas of communication:
    1. Sources of information (and misinformation) and how that is translated to the public, media, etc.
    2. How pharmacopeias, regulators, and other stakeholders share critical information (including Pharmacopeia Forum, Pharmeuropa, and internal company communications).

    10:00 a.m. – 10:05 a.m. | Recap of Wednesday's Session
    Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
    J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

    10:05 a.m. – 10:10 a.m. | Framework for the Session
    Bettine Boltres, PhD, Principal Scientific Affairs, West Pharmaceutical Services and
    Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia

    10:10 a.m. – 11:30 a.m. | Panel Discussion
    Graham D. Cook, PhD BPharm, Senior Director, Pfizer Inc.
    Michael C. Ganio, PharmD, Senior Director, Pharmacy Practice and Quality, ASHP
    Sabine Kopp, PhD, Team Lead, World Health Organization
    James Pound, BSc, Group Manager British Pharmacopoeia & Laboratory Services, MHRA
    Jaap Venema, PhD, Chief Science Officer, United States Pharmacopeia
    Cathie Vielle, Head of the European Pharmacopeia Department, EDQM Council of Europe

    11:30 a.m - 12:00 p.m. | Break

    12:00 p.m. – 2:00 p.m. | Conclusions: What Have We Learned? Where Do We Go From Here?
    Moderators: Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
    J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

    The closing session begins with an exploration of the impact of the pandemic on efforts aimed at achieving global harmonization of pharmacopeias. The moderators will then take stock of prior sessions from the conference, including a summary of key points and outcomes, as well as consideration of possible actions. A panel/round table discussion will provide an opportunity for conference attendees to engage in constructive dialogue to enable even more effective outcomes for future public health crises.

    12:00 p.m. – 12:30 p.m. | Global Harmonization Post Pandemic – A Prioritized Wish List
    Tina S. Morris, PhD, Executive Director, American Association of Pharmaceutical Scientists

    12:30 p.m. – 1:45 p.m. | Panel Discussion
    Rafael Hernández, QFB, Technical and Publications Manager, Mexican Pharmacopoeia
    Susanne Keitel, PhD, Director, European Directorate for the Quality of Medicines and HealthCare
    Gina M. Marsee, Director, Compendial Compliance & Advocacy, Merck & Co., Inc.
    Tina S. Morris, PhD, Executive Director, American Association of Pharmaceutical Scientists
    Manisha Trivedi, PhD, Scientific Assistant, Indian Pharmacopoeia Commission
    Peter Richardson, PhD, Quality, European Medicines Agency
    Jaap Venema, PhD, Chief Science Officer, United States Pharmacopeia

    1:45 p.m. – 2:00 p.m. | Closing Remarks and Final Wrap-up from Conference Co-Chairs
    Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
    J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC


Highlighted Speakers

Svein R. Andersen
Svein R. Andersen
Coalition for Epidemic Preparedness Innovation (CEPI)
Michael C. Ganio
Michael C. Ganio
ASHP
Sabine Kopp
Sabine Kopp
World Health Organization
Tina S. Morris
Tina S. Morris
American Association of Pharmaceutical Scientists
Ronald T.  Piervincenzi
Ronald T. Piervincenzi
United States Pharmacopeia
Zonghua Song
Zonghua Song
Chinese Pharmacopeia Commission
Marilyn R. Stebbins
Marilyn R. Stebbins
University of California, San Francisco, School of Pharmacy
Cathie Vielle
Cathie Vielle
EDQM

Learning Objectives

At the completion of this conference, participants will be able to:

  • Understand the roles of pharmacopeias, regulators, and the bio/pharmaceutical industry in maintaining the supply chain and avoiding drug shortages.
  • Understand how information is shared – the role of social media and other communications.
  • Understand the potential benefit and challenges of pharmacopeial standards, including global pharmacopeial convergence/harmonization for the quality and supply of medicines.
  • Recognize progress toward the development of new treatments, including compounded drugs and unlicensed medicines, re-purposing of existing medicines, discovering new therapies and supportive treatments, and the race to find new preventative medicines/vaccines.
  • Recognize where we are, what we have done, what we have learned, and where we are going in responding to public health crises.

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