Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 4 March 2024 to 8 March 2024

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

Metadata

Provider:

European Medicines Agency

URL:

https://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-37

Retrieved on:

Tuesday, January 2, 2024

Information

Tags:

Online, ICSR, European Economic Area, EMA, EudraVigilance, Terminology, EV, Announcement, ISO, Location, Environment

Geotags:

Summary

Key Points:

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.