Partner Katharine Latimer speaks at ACI's 24th Annual FDA Boot Camp in New York.
March 10, 2015
Firm partner Katharine R. Latimer addressed the conference as part of the panel, "Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls." Topics to be covered by the panel included:
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
For more information about the conference, download the agenda.