EudraVigilance 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) and supports the reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products. Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became mandatory on 30 June 2022 for all reporting to EudraVigilance. Furthermore, the use of ISO standard terminology for pharmaceutical dose forms and route of administration also became mandatory at the same time.

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 QPPV/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.