• Users who have to report and/or analyse suspected adverse reactions in the pre- and post-authorisation phase using the ISO/ICH E2B(R3) ICSR format;
• Users of EudraVigilance – new users and users already trained on working with EudraVigilance;
• Professionals performing electronic transmission of ICSRs, who operate as Gateway traders or as WebTrader (i.e., who use EVWEB or EV Post);
• Sponsors of Clinical Trials;
• National Competent Authorities or those acting on their behalf, in charge of pharmacovigilance and drug safety with obligations to report suspected adverse reactions related to medicines.

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 pharmacovigilance or SUSAR submission for clinical trials and to have basic background knowledge of:

• The ICH pharmacovigilance guidelines
• The EU pharmacovigilance legislation
• MedDRA coding
• GVP Module VI – Management and reporting of adverse reactions to medicinal products
• Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use
• GVP Module IX – Signal management and revised guidance on statistical methods

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

• Apply the ISO/ICH E2B(R3) format and rules to safety reporting based on practical examples for initial spontaneous and follow-up reports, amendment and nullification reports, literature and parent-child cases, and reports from interventional and non-interventional studies;
• Understand how to use EVWEB to create, send and access ICSRs and acknowledgments;
• Describe the principles of the EudraVigilance Data Analysis System (EVDAS) and access by Marketing Authorisation Holders (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 from the EEA submitted by national Competent Authorities (NCAs) and MAHs.