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Session 6: Biosimilar and Generics Labeling
Session Chair(s)
Paula Hudson, RPh, RAC
Director, Global Labeling, Eli Lilly and Company, United States
This session includes invited speakers from industry, FDA, and Health Canada to provide a balanced view of packaging issues. The industry portion will discuss considerations and challenges when developing the packaging materials, including timing (when to start), branding, and regional differences. Regulatory perspectives include insights from an FDA Safety Reviewer, and a discussion on Canada’s draft guidance, “Good Label and Packaging Practices Guide (2015)”.
Speaker(s)
Joseph P. Thomas, JD, PharmD, RPh
Chair of Life Sciences Group and Co-Chair, Litigation, Ulmer & Berne LLP, United States
US Generics Labeling
David H. Dorsey, JD, MA
Senior Director, Americas Head, Global Regulatory Policy and Intelligence, Janssen Research & Development, LLC, United States
US Draft Biosimilars Labeling Guidance
Bruce Leicher, JD
Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc., United States
Speaker
David H. Dorsey, JD, MA
Senior Director, Americas Head, Global Regulatory Policy and Intelligence, Janssen Research & Development, LLC, United States
Panelist
A. Leander Fontaine, MD
President, Pharmiceutics, LLC., United States
Panelist
Bruce Leicher, JD
Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc., United States
Panelist
Julie P. Retzinger, MBA, RN
Senior Director - Global Labeling and CCDS, Astellas Pharma Inc., United States
Panelist
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