The new and enhanced EudraVigilance system became operational on 22 November 2017 and brought about significant changes to electronic reporting requirements and access to reports of suspected adverse reactions related to medicines by marketing authorisation holders in the EEA.

In addition, EMA and the European Commission have agreed transitional arrangements to streamline the monitoring of EudraVigilance by marketing authorisation holders. During a pilot period of one year, which started on 22 February 2018, MAHs of the active substances included in the list published in October 2017, will have to monitor them in EudraVigilance.

This EudraVigilance Information Day provides a forum to discuss the initial experience of stakeholders with the new EudraVigilance system functionalities focusing on procedural, technical and data quality aspects and the use of the new ICH E2B(R3) standard. In addition, this Information Day will allow the audience to interact with signal management experts from EMA and national Competent Authorities and to learn from the approach of marketing authorisation holders involved in the pilot.

The faculty invites participants to submit related questions by 23 February 2018 latest to emaevents@diaglobal.org.