Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls
Linda Pissott Reig
Shareholder
Buchanan Ingersoll & Rooney PC
Katharine R. Latimer
Partner
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