Preparing for the Worst: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls

September 15, 2022 11:45am

Beth Weinman
Counsel
Ropes & Gray LLP (Washington, DC)

  • 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
  • Exploring protocols for Risk Evaluation and Minimization Strategies (REMS)
  • Understanding the role of risk evaluation in the approval process
  • Identifying risk minimization tools
  • Enforcing ADE reporting and REMS requirements
  • Examining the relevance to product liability risks, including innovator and co-promoter liability risks
  • What is the FDA’s recall and oversight authority (overview of 21 CFR Part 7)?
    • Guidance versus regulation
    • Market withdrawals and stock recoveries
    • Voluntary recalls versus mandatory recalls
  • Interaction between recalls and corrective and preventive action