The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format
EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines, which have been authorised in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network and will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. The system will make use of the Individual Case Safety Report (ICSR) standards as developed by the International Organization for Standardization (ISO) in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good harmacovigilance 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.
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 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 of EudraVigilance – new users and users already trained on working with EudraVigilance including
- Professionals of Marketing Authorisation Holders
- Sponsors of a 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 have basic background knowledge of:
- 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.
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 acknowledgments
- 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