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EMA (EU)
EVENT
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system
Published: 11/10/2026Detected: 10/31/2026

Summary preview

Requires EU stakeholders to use ISO/ICH E2B(R3) for individual case safety reporting (ICSR) in EudraVigilance, with the change becoming mandatory as of 30 June 2022.

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safety
clinical
#EudraVigilance
#EVWEB
#ICSR
#ISO/ICH E2B(R3)
#individual case safety report

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