J. Mark Wiggins, MS Global Pharmacopoeia Solutions LLC

J. Mark Wiggins is Owner and Compendial Consultant with Global Pharmacopoeia Solutions LLC, which he formed after more than 30 years’ experience in the pharmaceutical industry. He was previously Director of Compendial Affairs at Merck & Co., Inc., (known as MSD outside the US and Canada), with more than 15 years’ experience submitting new and revised monographs to pharmacopoeias, as well as optimizing processes for review and response to proposed compendial changes from around the world. Mr. Wiggins has been an active participant in pharmaceutical industry associations in the US, UK, and Europe, and represented PhRMA on the ICH Q4B Expert Working Group to harmonize pharmacopoeia general chapters. Mr. Wiggins has published numerous papers, including an introduction to the concept of the "Ideal Pharmacopoeia," "Compendial Globalization," and the industry perspective on the pilot project for “Prospective Harmonization” of API monographs. He also co-authored a comprehensive series of twelve articles on pharmacopoeia compliance that were published as online regulatory sourcebooks. He has been an invited speaker at international meetings on compendial harmonization, including the Ph. Eur. workshop "Quality of Medicines in a Globalized World," and in discussions with pharmacopoeias and regulators in the US, UK, Europe, Japan, China, Korea, and India.