Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System
The European Medicines Agency (EMA) launched the enhanced EudraVigilance system in November 2017, which supports reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products. Based on a Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, the EMA Management Board(1) confirmed and announced the mandatory use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3)(2) modalities as of 30 June 2022 for all reporting to EudraVigilance. Furthermore, the use of ISO standard terminology for pharmaceutical forms and route of administration also became mandatory at the same time.
The training course includes a knowledge evaluation for which participants, who pass the evaluation, will receive a notification from the EMA. Organisations, which aim 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 be able to successfully register with the EudraVigilance production environment. For more information on the registration process, please consult the EMA website.
Who should attend?
- Users who have to report and 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 are expected to work in pharmacovigilance and to have basic background knowledge of:
- The ICH pharmacovigilance guidelines
- 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 EudraVigilance system training can be found on the dedicated EMA EudraVigilance training page.
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