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Commercialization
Session Chair(s)
David Gaugh, RPh
Senior Vice President for Sciences and Regulatory Affairs
Generic Pharmaceutical Association (GPhA), United States
During this session, government and industry experts, from a broad range of backgrounds and experiences, will provide in-depth overviews on substitution and interchangeability and on naming and labeling as they relate to the biosimilar market. Experiences from the European biosimilar market as well as other non-US regulated markets will be incorporated to provide overviews.
Speaker(s)
Interchangeability & Substitution
Gillian Woollett, PhD, MA
Samsung Bioepis, United States
Vice President, Head Regulatory Strategy and Policy
Interchangeability & Substitution
Steve Miller, MD
Express Scripts, United States
Senior Vice President & Chief Medical Officer
Interchangeability & Substitution
Thomas Felix, MD
Amgen Inc., United States
Medical Director, R&D Policy, Global Regulatory Affairs and Safety
Naming & Labeling
Erika F. Lietzan, JD, MA
University of Missouri, United States
Associate Professor of Law
Naming & Labeling
Joerg Windisch, PhD
Sandoz Biopharmaceuticals, Austria
Chief Science Officer
Panel Discussion
All Session Speakers, United States
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