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Regulatory expectations related to biotechnology and biological products are continually evolving both within mature and emerging regulatory agencies. This session will provide a snapshot of recent regulatory changes across the global landscape. Invited speakers will provide a sampling of some of the recent regulatory responses related to the ongoing COVID-19 pandemic, discuss the rapidly evolving regulatory landscape in China, and highlight some of the recent trends related to sterile products in the United States.
Moderator(s):
Christine
M. Moore,
PhD,
Executive Director, Quality Systems & Compliance,
Organon LLC
Speaker(s):
Joseph
Famulare,
Conference Chair, VP Global Compliance & External Collaboration,
Genentech, A Member of the Roche Group
Mr. Rick
Friedman,
Deputy Director, Office of Manufacturing Quality,
FDA/CDER
Lawrence
Hill,
PharmD,
CEO,
Gan & Lee Pharmaceuticals USA
Credits
Credits: None available.
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