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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 Regulatory perspectives include insights from an FDA Safety Reviewer, and a discussion on Canada’s draft guidance, “Good Label and Packaging Practices Guide (2015)”.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)
US Generics Labeling
Joseph P. Thomas, JD, PharmD, RPh
Ulmer & Berne LLP, United States
Chair of Life Sciences Group and Co-Chair, Litigation
US Draft Biosimilars Labeling Guidance
David H. Dorsey, JD, MA
Janssen Research & Development, LLC, United States
Senior Director, Americas Head, Global Regulatory Policy and Intelligence
Speaker
Bruce Leicher, JD
Momenta Pharmaceuticals, Inc., United States
Senior Vice President and General Counsel
Panelist
David H. Dorsey, JD, MA
Janssen Research & Development, LLC, United States
Senior Director, Americas Head, Global Regulatory Policy and Intelligence
Panelist
A. Leander Fontaine, MD
Pharmiceutics, LLC., United States
President
Panelist
Bruce Leicher, JD
Momenta Pharmaceuticals, Inc., United States
Senior Vice President and General Counsel
Panelist
Julie P. Retzinger, MBA, RN
Astellas Pharma Inc., United States
Senior Director - Global Labeling and CCDS