Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system - May 2026

• Date:
  Tuesday, 05 May 2026 , 14:00 - 18:00 Amsterdam time (CEST)
  Wednesday, 06 May 2026 , 14:00 - 18:30 Amsterdam time (CEST)
  Thursday, 07 May 2026 , 14:00 - 18:30 Amsterdam time (CEST)
• Location:
  Online
  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 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

Documents

Agenda - Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system (February, May 2026)