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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.