Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls

March 11, 2015 11:30am

Linda Pissott Reig
Buchanan Ingersoll & Rooney PC

Katharine R. Latimer
Hollingsworth LLP (Washington, DC)

Jill Andersen
General Counsel OTC-US
Novartis Consumer Health, Inc.

  • 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, 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