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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: 10/26/2026Detected: 10/16/2026

Summary preview

Mandates a practical transition toward using ISO/ICH E2B(R3) for electronic Individual Case Safety Reports (ICSRs) in the EU via EudraVigilance, with emphasis on hands-on capability building.

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safety
clinical
#EudraVigilance
#ICSR
#ISO/ICH E2B(R3)
#electronic reporting
#pharmacovigilance

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