Overview

The European Medicines Agency (EMA) launched the new 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 using the ICH E2B(R3) Individual Case Safety Report (ICSR) format[1]. The EMA operates the EudraVigilance system on behalf of the European Union (EU) medicines regulatory network.

Please visit the dedicated EudraVigilance training and support webpage on the EMA website for more information.

This hands-on training course covers:

In depth explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR Implementation Guide
The use of the EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3) format and to practice examples for various reporting scenarios
Reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products”
How to comply with the EudraVigilance business rules and the EudraVigilance Access Policy
Training on the transmission of ICSRs in the E2B(R3) format via the EudraVigilance Gateway (including WebTrader (EVWEB, EV Post and Gateway Traders)
Instruction on using the ICSR download functionality for MAHs to access ICSRs

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 EMA website.

[1] http://estri.ich.org/e2br3/index.htm

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 of Marketing Authorisation Holders from all type of organisations performing electronic transmission of ICSRs, Gateway Traders and Web Trader (EVWEB and 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

Learning objectives

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 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

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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Overview

Who should attend?

Learning objectives

Be informed and stay engaged.