Adverse Events Monitoring, Pharmacovigilance and Risk Management

September 19, 2014 9:00am

David L. Rosen
Foley & Lardner LLP

Howard L. Dorfman
Senior Vice President and General Counsel
Turing Pharmaceuticals

  • What is pharmacovigilance?
  • How pharmacovigilance uses adverse event reports
    • direct versus indirect reports
    • causality assessments
    • labeling changes
    • pre- and post-market ADE reporting requirements
    • how regulatory agencies use ADE reports
  • Risk Evaluation and Minimization Strategies (REMS)
  • Risk evaluation in the approval process
  • Risk minimization tools
  • Enforcement of ADE reporting and REMS requirements
  • Examining the relevance to product liability risks