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