Workflow
ICSR Submission
Individual case safety report (ICSR) submission remains a core pharmacovigilance obligation worldwide. Follow FDA E2B(R3) transition deadlines, AEMS/FAERS technical changes, EU expedited reporting rules, and quality metrics for case completeness — with workflow impacts for safety database admins and PV operations leads.
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Digest roles: QPPV. Work email only · workflow ICSR Submission