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2020 ISPE Biopharmaceutical Manufacturing Virtual Conference


Regulatory Updates on Biotechnological & Biological Products


Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Description

Regulatory Updates on Biotechnological & Biological Products

Regulatory Updates on Biotechnological and Biologic Products 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.

  • COVID-19 Pandemic Regulatory Responses
    Joseph Famulare, Vice President, Global Quality Compliance and External Relations Genentech, A Member of the
    Roche Group  
  • Update on Sterile Products and Change Management
    Richard Friedman, Deputy Director, Science & Regulatory Policy
    CDER, FDA  
  • Regulatory Requirement Differences Between China and US for Biologics & Biosimilars
    Lawrence A. Hill, PharmD, RPh, MBA, CEO
    Gan &Lee Pharmaceuticals USA

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