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Session 16: Aggregate Reporting for Marketed Products
Session Chair(s)
Mark Vieder, MBA, RPh
Vice President, Drug Safety and Pharmacovigilance
Biorasi, LLC, United States
This session will address post-marketing 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).
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