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Session 25: Aggregate Reporting for Marketed Products
Session Chair(s)
Jill W. Buckley, PharmD
Adjunct Assistant Professor
Rutgers, the State University of New Jersey, United States
This session will address postmarketing periodic reports, including the US Periodic Adverse Drug Experience Report (PADER) and the EU Periodic Safety Update Report (PSUR in ICH Periodic Benefit Risk Evaluation Report format).
- Periodic Benefit-Risk Evaluation Report
- Periodic Adverse Drug Experience Report
- Annual Product Review
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