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.
Global Head and Executive Director, GRACS CMC Policy,
Merck & Co., Inc.
Conference Chair, VP Global Compliance & External Collaboration,
Genentech, A Member of the Roche Group
Deputy Director, Office of Manufacturing Quality,