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Regulatory Updates on Biotechnological and Biologic Products

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

Credits: None available.


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.


  • Christine Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.


  • 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


Credits: None available.

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