(0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual

Feb 10, 2026 9:00 AM - Feb 12, 2026 1:00 PM

(Central Europe Standard Time)

Virtual Live Hands-On Training Course for Clinical Trials Sponsors Using The EudraVigilance System

Virtual live training course including EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system. Check the - WHO SHOULD ATTEND - section for more information regarding course pre-requisites.

Register
CONTACT US
Send Email +41 61 225 51 51

Overview

EudraVigilance (EV) 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). The use of the ISO Individual Case Safety Report (ICSR)
standard based on the ICH E2B (R3) modalities became mandatory on 30
June 2022.
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 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. For more information on the registration process,
please consult the EMA website.

Who should attend?

This training course is intended for

  • Users who have to report and analyse SUSAR reactions originated in the context of Clinical Trials, using the ISO/ICH E2B(R3) ICSR format
  • Users of EudraVigilance – new users and users already trained on working with EudraVigilance
  • Sponsors of Clinical Trials from all type of sender organisations performing electronic transmission of ICSRs, Gateway Traders and Web Trader (EVWEB and EV Post)

Participants need an active EMA account for the practical exercises in the EVWEB test environment (XCOMP). Participants are also required to have a good command of the English language and be proficient in using a computer and Zoom to participate effectively in the course.

Furthermore, participants are expected to work in SUSAR submission for clinical trials and to have basic background knowledge of:

  • The ICH pharmacovigilance guidelines
  • Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use


Learning objectives

At the conclusion of this training course participants will be able to:

  • Apply the ISO/ICH E2B(R3) format and rules to safety reporting based on practical examples for initial SUSARs and follow-up reports, amendment and nullification reports, parent-child cases, and reports from interventional studies
  • Understand how to use EVWEB to create, send and access ICSRs and acknowledgments
  • Query, view, browse and download ICSRs

Have an account?

Download registration form Register

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.