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Session 21: 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 for marketed products and will highlight various challenges.
- Sources
- Data elements
- Follow-up
- Role of case narratives
- Special situations (e.g., literature, pregnancy, lack of efficacy, product technical complaints, legal cases)
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