The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course

• Date:
  Monday, 8 April 2019
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing individual case safety reports (ICSR) in the new ISO/ICH E2B(R3) format.

It covers reporting principles in accordance with the guideline on Good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

For more information, see EudraVigilance training and support.