Free Resource
Is Your Biotech Ready for
ICH E2B(R3)?
The FDA mandatory deadline for electronic ICSR submission in E2B(R3) format is April 1, 2026. This checklist walks IND sponsors and PV teams through every readiness requirement, from submission infrastructure to adverse event intake to documentation.
26 specific compliance checkpoints across 4 domains
Mapped to 21 CFR 312.32 and FDA April 2024 final guidance
Covers intake, case management, ESG setup, SOPs, and training
Written by a pharmacovigilance QA director with 15 years in biotech
Submission Infrastructure
AE Intake
Case Management
SOPs + Training
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