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"Global Regulatory Changes and Resulting Implications On Drug Safety"


Bruce Donzanti, Genentech inc, spoke at the 2014 World Drug Safety Congress. Donzanti gave a presentation on "Global Regulatory Changes and Resulting Implications On Drug Safety".

Download and learn:

  • Recent major global Drug Safety Regulatory Changes 
  • Differences and Bridging the Gaps
  • Health Agency Perspective on Solicited Programs
  • CIOMS V: Concept of Incidental Data
  • Solicited Programs: Volume and Interactions
  • A Risk-Based Approach to Solicited Program Management
  • Potential Types of Social Media and Safety Reporting Requirements



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