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2020 ISPE Biopharmaceutical Manufacturing Virtual Conference


Regulatory Updates on Biotechnological and Biologic Products


Jun 2, 2020 9:00am ‐ Jun 2, 2020 10:30am

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
  • Richard Friedman, Deputy Director, Science & Regulatory Policy, CDER/FDA
  • Lawrence Hill, PharmD, CEO, Gan & Lee Pharmaceuticals USA

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