Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Face-to-face training course including EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system. Check the - WHO SHOULD ATTEND - section for more information regarding course pre-requisites.

Send Email +41 61 225 51 51

Agenda

Day 1 Oct 26, 2026

9:00 AM — 6:00 PM

Introduction to the enhanced EV system; Key elements of the ICSR in ISO/ ICH E2B(R3) format; Creating an ICSR and sending of a safety message

Day 2 Oct 27, 2026

9:00 AM — 6:00 PM

Creating an ICSR and sending of a safety message; Creating, sending and receiving acknowledgment

Day 3 Oct 28, 2026

9:00 AM — 3:00 PM

EV Post Function; Access to EudraVigilance Data: EVDAS and EVWEB; EudraVigilance Export Manager: ICSR download functionality for MAHs

Have an account?

Download registration form

Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Agenda

Be informed and stay engaged.