Overview

EudraVigilance is the European data-processing network and management system, established at the European Medicines Agency (EMA) to support the electronic exchange, management and scientific evaluation of Individual Case Safety Reports (ICSRs) related to all medicinal products authorised in the European Economic Area (EEA).
This training course covers all aspects on the functionalities of the EudraVigilance system specifically EVWEB, with regard to electronic reporting of ICSRs including practical examples and exercises in the EudraVigilance training environment. It includes fundamentals of electronic transmission of ICSRs and ICH M2 safety and acknowledgment message specifications, as well as ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and current EudraVigilance Business Rules. It should be noted that the course content is regularly updated in order to comply with new regulations and requirements.
Participants who pass the knowledge evaluation following this training course will receive a notification from the EMA that will allow them to register with the EudraVigilance production environment and to report ICSRs to the European Medicines Agency and/or the National Competent Authorities in the EEA. For more information on this registration process, please consult the EudraVigilance website.

Who should attend?

Professionals of Marketing Authorisation Holders, Sponsors of clinical trials, National Competent Authorities or those acting on their behalf, in charge of pharmacovigilance and drug safety with legal reporting obligations in the EEA who wish to use the EudraVigilance system.
Participants are expected to have a minimal background knowledge of the EU Community legislation and guidance documents related to the monitoring of safety of clinical trials and post-authorisation pharmacovigilance activities that can be found on the EudraVigilance website:
http://eudravigilance.ema.europa.eu/human/euPoliciesAndDocs.asp

Learning objectives

At the conclusion of this training course participants should be able to:

Apply ICH rules to safety reporting
Describe the Registration process with EudraVigilance
Understand the concepts of electronic transmission of ICSRs
Describe the EudraVigilance Gateway
Describe the Webtrader functions
Explain the reporting processes for fully-automated organisations, Post-function users, and EVWEB users
Create, validate and send safety messages (initial, follow-up reports, nullification reports, literature reports, parent-child , study reports, reports with medical and drug history)
Create and send acknowledgments of received ICSR messages
Query, view, browse and download safety reports
Query, view and browse MedDRA through the EVWEB

Have an account?

EudraVigilance - electronic reporting of ICSRs in the EEA

Overview

Who should attend?

Learning objectives

Be informed and stay engaged.