Posted by Michael Wonder on 04 Oct 2017
Countdown to launch of new EudraVigilance system
4 October 2017 - Final preparations for change-over to new system underway for go live date on 22 November 2017
On 22 November 2017, the EMA will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area. The new system will have enhanced features for the reporting and analysis of suspected adverse reactions to support a better safety monitoring of medicines and a more efficient reporting process for stakeholders.
The change-over from the current to the new version of EudraVigilance requires the transfer of more than 11 million Individual Case Safety Reports from the post-authorisation phase and clinical trials, as well as associated information. To allow the accurate transfer of such a large volume of data, some functionalities of the system will be entirely or partially unavailable for a period of ten working days, from 8 to 21 November 2017.
