Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, European Medicines Agency, Amsterdam, the Netherlands, from 9 November 2026 to 13 November 2026

Date

Monday, 09 November

Friday, 13 November 2026

,

All day

Location

European Medicines Agency, Amsterdam, the Netherlands

Event summary

EudraVigilance (EV) is the EU's system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA).

The use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B (R3) modalities became mandatory on 30 June 2022.

Following the completion of this course, participants who pass the knowledge evaluation will receive a notification from the EMA.

Organisations which aim to register first user QPPV/RP or to use EudraVigilance web application (EVWEB) to start the electronic reporting of ICSRs to EudraVigilance for the first time, need to provide such notification for at least one user to the EMA to be able to successfully register with the EV production environment.

Registration

Registration is open via the below link:

• Mandatory use of ISO/ICH E2B(R3) registration

Documents

Agenda - Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system

English (EN) (1.02 MB - PDF)

First published:

20/05/2026

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