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