Drug Safety and Pharmacovigilance Across the Product Lifecycle

Build a solid foundation in the key concepts of drug safety and pharmacovigilance throughout the medical product development lifecycle. Learn how to comply with regulatory requirements.

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Session 19: Individual Case Safety Reports

Session Chair(s)

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

This session will focus on individual case safety reports (ICSRs) for marketed products and will highlight various challenges. Topics include sources of data, data elements, best practices for follow-up, role of narratives and special situations including literature, pregnancy, lack of efficacy, product technical complaints, and legal cases.