03.09.2026
To the attention of interested persons
EudraVigilance training on electronic reporting of ICSRs in the ICH E2B(R3) format
The NAMMDR would like to inform you about the EMA training course “Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on using the EudraVigilance System” which will be held in Bucharest, Romania, between 26-28 October 2026. The training will take place at the Hotel Capital Plaza, Bucharest.
This hands-on training course is designed for professionals performing electronic transmission of ICSRs (Gateway traders or WebTraders), Sponsors of Clinical Trials, National Competent Authorities, and users reporting or analysing suspected adverse reactions in pre- and post-authorisation phases. The course aims to provide an in-depth explanation of the EudraVigilance (EV) system and a practical application of the ISO/ICH E2B(R3) format—which became mandatory on 30 June 2022—to safety reporting in EudraVigilance.
Detailed information is available on the EMA website at the following link: https://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-59.
Event agenda is available here: EudraVigilance training Agenda.