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

September 21, 2023 11:45am

Beth Weinman
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
      • Voluntary recalls versus mandatory recalls
      • Market withdrawals and stock recoveries
    • Interaction between recalls and corrective and preventive action