Description
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
Moore,
PhD,
Global Head and Executive Director, GRACS CMC Policy,
Merck & Co., Inc.
Speaker(s):
- Joseph
Famulare,
Conference Chair, VP Global Compliance & External Collaboration,
Genentech, A Member of the Roche Group
- Rick
Friedman,
Deputy Director, Office of Manufacturing Quality,
CDER/FDA
- Lawrence
Hill,
PharmD,
CEO,
Gan & Lee Pharmaceuticals USA
