Course Description

Pharmacopoeias: A Global Perspective for Compendial Compliance

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Course ID 2728

In-Person Course

Who Should Attend?
This course is intended for individuals who have the responsibility for ensuring compliance with requirements in the pharmacopoeias, and is broadly applicable to the global bio/pharmaceutical industry, including innovator, generic, biotechnology, consumer-care and related industries. This course will benefit individuals in:

  • Compendial affairs
  • Regulatory affairs/CMC
  • Quality assurance/Quality control
  • Analytical chemistry/Process chemistry
  • R&D/New products/Method development
  • Contract manufacturers/laboratories

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Course Description
Compliance with compendial requirements is a legal and regulatory requirement in those countries in which the pharmacopoeia is applicable. There is currently a reasonably broad understanding regarding the applicability of USP-NF requirements in the US, Ph. Eur. and BP requirements in Europe, and JP requirements in Japan. However, there is less understanding of regulatory expectations regarding applicability of these same pharmacopoeias in other countries. Additionally, with increasing globalization in the bio/pharmaceutical industry, other pharmacopoeias are becoming more important, including those in Brazil, Russia, India, China and Korea. Further complicating the compliance picture is the interplay of compendial requirements and approved registrations for drug products.

This comprehensive 2-day course will provide an understanding, including practical examples of compliance with compendial requirements, as published by pharmacopoeias. The course includes an introduction to the pharmacopoeias, with an emphasis on the USP-NF, Ph. Eur. and BP. A global perspective is presented, with consideration also given to the pharmacopoeias in other important countries. Details of the content, organization and use of the pharmacopoeias are presented, along with regulatory considerations and applicability of compendial requirements. There is a detailed exploration of the development and revision processes for compendial standards, with real-life case studies offered. Efforts toward compendial harmonization are described, with information on the activities of the Pharmacopoeial Discussion Group (PDG) and prospective harmonization of drug substance/product monographs. The course concludes with an exploration of approaches to compendial surveillance, opportunities for advocacy, and – ultimately – compliance with the requirements in the pharmacopoeias.

In addition to gaining in-depth knowledge of the pharmacopoeias, the course will assist the global bio/pharmaceutical industry, including innovator, generic, biotechnology and consumer-care companies, seeking greater understanding of compliance with USP-NF, Ph. Eur. or BP requirements, within and outside the US and EU borders. Information is also provided for companies to understand key elements of compliance with national pharmacopoeias in other countries.

Course Director
J. Mark Wiggins, B.S., M.S.

J. Mark Wiggins is Director of the compendial group at Merck & Co., Inc., West Point, PA, U.S.A. (known as MSD outside the United States and Canada), with over 30 years’ experience in the pharmaceutical industry. His current responsibilities include ensuring compliance with compendial requirements, preparing and submitting new and revised monographs to the pharmacopoeias for drug products, drug substances, and excipients, as well as reviewing and responding to proposed compendial changes published by pharmacopoeias around the world. Prior to his current position, Mr. Wiggins was responsible for testing and releasing excipients for use in formulation design, scale-up, and clinical supplies. He also has experience in the synthesis and characterization of active pharmaceutical ingredients for use in the treatment of HIV/AIDS, cancer, diabetes, hypercholesterolemia, and depression.

Mr. Wiggins has been an active participant in compendial harmonization efforts, serving as PhRMA representative on the ICH Q4B Expert Working Group, and leading several face-to-face meetings with pharmacopoeias on the topic of harmonization. He is also an active contributor to several industry-based compendial discussion groups, and has chaired the US-based PhRMA compendial team, which has important connections with EFPIA, based in the EU. He has been an invited speaker in several international meetings, including presentations on compendial harmonization at the Ph. Eur. workshop on “Quality of Medicines in a Globalized World”, and more recently at meetings with the pharmacopoeias and regulators in the US, Europe, India, Japan, Korea, and China.

Mr. Wiggins has authored several papers covering each area of his career. Recent articles include introductions to the concepts of the “Ideal Pharmacopoeia” and “Compendial Globalization”, as well as the industry perspective on the pilot project to achieve “Prospective Harmonization” for API monographs. Mr. Wiggins holds degrees in Chemistry from Trinity University and the University of Wisconsin, both in the US.

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