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Session 24: Aggregate Reporting, Part 3
Session Chair(s)
JP Clement, MD
Founder and Principal
JPCC Associates, 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), with a cameo description of the “old” format PSUR still required in some jurisdictions.
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