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Pharmacopoeias: A Global Perspective for Compendial Compliance
March 12-13, 2018
New Brunswick, NJ
Course Offering 180312NJ2728
Course ID 2728
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
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.
New Brunswick, NJ Area
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