#110: Updates and Pending Issues in the US Biosimilar Environment
Chair AR
Director, Global Regulatory Policy, Merck & Co., Inc.
Andrew S. Robertson works in Global Regulatory Affairs at Merck & Co., focusing on regulatory policies concerning vaccines, biologics, biosimilars, in vitro diagnostics, mobile medical apps and software medical devices. He has over 13 years of experience spanning academia, industry...
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Speakers
Director, Research and Development Policy, Amgen Inc.
Senior Director, Regulatory Policy, Novo Nordisk A/S
Karen Hauda is the Senior Director for Regulatory Policy in the Clinical Development, Medical and Regulatory Affairs Division at Novo Nordisk. In this role, she supervises regulatory advocacy and develops filing strategies to positively influence the regulatory environment in the...
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Global Head Biopharm and Oncology Injectables Development, Sandoz, Inc
Dr. McCamish is a physician scientist with a long history of drug, biologic, and biosimilar development in large and small organizations. He is currently Global Head of Biopharmaceutical Development for Novartis biosimilar development housed in Sandoz International.
Monday June 27, 2016 8:30am - 9:45am EDT
201B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 08: Reg Affairs,
Forum
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Biologics-Biosimilars, GDUFA-Generics
- Interest Area Biotechnology, Regulatory Affairs
- format json
- Interest Area Biotechnology,Regulatory Affairs
- Featured Topics Biologics/Biosimilars,GDUFA/Generics
- Credit Type ACPE, CME, IACET, RN
- Tags Forum