Workflow
Aggregate Reporting
Periodic safety update reports (PSURs/PBRERs) and development safety update reports (DSURs) are central to lifecycle pharmacovigilance. Track EU PRAC assessment timelines, FDA postmarketing study commitments, and guidance affecting aggregate report content, submission windows, and QPPV sign-off responsibilities.
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Digest roles: QPPV. Work email only · workflow Aggregate Reporting