Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course on using the EudraVigilance system
This training course covers the use of the ISO ICSR/ICH E2B(R3) format and related ISO standard terminology for pharmaceutical form and route of administration for reporting individual cases of suspected side effects to EudraVigilance.
It is is aimed at all EudraVigilance users who have to report and analyse suspected adverse reactions in the pre- and post-authorisation phase. This includes:
- marketing authorisation holders;
- sponsors of clinical trials;
- staff at national competent authorities.
Using the ISO ICSR/ICH E2B(R3) format and related terminologies became mandatory on 30 June 2022. For more information, refer to Guidance on using new ISO standard format for individual case safety reports under Change management for the EudraVigilance system.