Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System
The European Medicines Agency (EMA) launched the enhanced EudraVigilance system in November 2017, which supports reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products.
Based on a Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, the EMA Management Board confirmed and announced the mandatory use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3)1 modalities as of 30 June 2022 for all reporting to EudraVigilance. Furthermore, the ISO standard terminology for pharmaceutical forms and route of administration will also become mandatory at the same time. The use of the ICH E2B (R2) format will therefore be phased out.
The training course includes a knowledge evaluation for which participants, who pass the evaluation, will receive a notification from the EMA. Organisations, which aim 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 be able to successfully register with the EudraVigilance production environment.