EudraVigilance Course

13.03.2019 - 15.03.2019


By the end of this training course, participants should be able to:

• Describe the EudraVigilance System components

• Apply ISO/ICH E2B(R3) rules to safety reporting based on practical examples for initial and follow-up reports, amendment and nullification reports, literature and parent-child cases, and reports from studies

• Understand how to use EVWEB to create, send and access ICSRs and acknowledgements

• Describe the principles of EVDAS and access by MAHs to use electronic Reaction Monitoring Reports (e-RMRs), line listings and ICSR forms

• Query, view, browse and download ICSRs using the EudraVigilance ICSR Download Functionality, which provides access by marketing authorisation holders (MAHs) to ICSRs submitted by National Competent Authorities (NCAs) in the EEA.



• Users of EudraVigilance - new users and users already trained on working with EudraVigilance including

• The EU pharmacovigilance legislation

• GVP Module VI - Management and reporting of adverse reactions to medicinal products

• Guidance documents related to the monitoring of safety of clinical trials (CT3)

• GVP Module IX - Signal management and revised guidance on statistical methods  


Further information on the new EudraVigilance system training can be found on the dedicated EMA EudraVigilance training page.

Please register online at

Please register online at
Responsible for program:
Contact for event:
DIA Europe, Middle East and Africa Contact Centre Team
Tel: +41 61 225 51 51
Location: AGES
Spargelfeldstrasse 191
A-1220 Vienna
Category: hands-on training course

Entry: 1.850 EUR (925 EUR for academia/charitable/government/non-profit)