Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls
Thomas J. Cosgrove
Partner
Covington & Burling LLP
- 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 and when long-term safety studies are required
- 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