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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: 10/12/2026Detected: 10/2/2026

Summary preview

Mandates ISO/ICH E2B(R3) formats for individual case safety reporting (ICSRs) in the EU, effective since 30 June 2022, and drives operational readiness through hands-on training on EudraVigilance (EV).

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safety
clinical
#EudraVigilance
#E2B(R3)
#ICSR
#ISO ICSR
#EVWEB

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