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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
  • 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. | 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
    Martin G. VanTrieste, BS Pharmacy, President & CEO, Civica Inc.

    11:00 a.m. – 11:20 a.m. | Regulatory Representative Invited

    11:20 a.m. – 11:40 a.m. | Pharmacopeia Representative Invited

    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. | Dirk Leutner, Head of Pharmaceutical Technology Section, EDQM, Council of Europe

    12:50 p.m. – 1:10 p.m. | Pharmacopeia Representative Invited

    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. | Shigeki Tsuda, MS, Senior Managing Director, Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ)

    1:50 p.m. – 2:10 p.m. | Pharmacopeia Representative Invited

    2:10 p.m. – 2:30 p.m. | Q&A Panel

  • Wednesday, September 30

    10:00 a.m. – 2:00 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. – 11:10 a.m. | Pharmacopeia, Regulatory, and Industry Representatives Presentations on Vaccines

    11:10 a.m.  – 11:30 a.m. | Vaccines Discussion

    11:30 a.m.  – 12:00 p.m. | Break

    12:00 p.m. – 12:40 p.m. | Pharmacopeia and Industry Representatives Presentations on New Therapeutics

    12:40 p.m. – 1:00 p.m. | New Therapeutics Discussion

    1:00 p.m. – 1:40 p.m. | Regulatory Representatives Presentations

    1:40 p.m. – 2:00 p.m. | Regulatory View Discussion
  • 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
    James Pound, BSc, Group Manager British Pharmacopoeia & Laboratory Services, MHRA

    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
    Gina M. Marsee, Director, Compendial Compliance & Advocacy, Merck & Co., Inc.
    Tina S. Morris, PhD, Executive Director, American Association of Pharmaceutical Scientists

    1:45 p.m. – 2:00 p.m. | Closing Remarks and Final Wrap-up from Workshop 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

Joseph Albanese
Joseph Albanese
Janssen Pharmaceuticals R&D, LLC (Johnson and Johnson)
Bettine Boltres
Bettine Boltres
West Pharmaceutical Services
Matthew W. Borer
Matthew W. Borer
Eli Lilly and Company
Tina S. Morris
Tina S. Morris
American Association of Pharmaceutical Scientists
Ronald T.  Piervincenzi
Ronald T. Piervincenzi
United States Pharmacopeia
James Pound
James Pound
MHRA
Martin G. VanTrieste
Martin G. VanTrieste
Civica Rx
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.

Registration Fees

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Registration Type Fee
Member $1,596
Non-member $1,875
Young Professional Member $798
Gov’t/Health Auth./Academic Member $560
Gov’t/Health Auth./Academic Non-member* $640
Student Member $224
Student Non-member* $248

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