On 11th April the EMA announced their plans to prepare for the launch of the New Eudravigilance System (EV8) which is timetabled for November 2017. They are calling for early registration of NEW users for the novel XCOMP (Test) and the production environments.
The new EudraVigilance XCOMP will be released on 26 June 2017. If your ICSR testing includes the new ICH E2B(R3) format or uses the new EVWEB interface using the ICSR download manager, they urge companies to perform such testing ASAP!
The exact date of release of the new production environment in November remains to be decided – but will be confirmed in Q3 2017.
Existing EV users who are currently registered will be automatically migrated to the new EV environments and need do nothing further. It is however, advised that existing users should review their profiles and check that their current passwords and user names remain valid. Accounts for people who have moved responsibilities or companies should be notified to EV so the accounts can be closed. Queries on access issues should be emailed to EudraVigilanceRegistration@ema.europa.eu.
As of 27 June 2017, IT vendors for gateway software solutions that allow for electronic transmission of ICSRs to EV may also register under a dedicated IT vendor category for use of the new XCOMP environment by sending an email to VendorTesting@ema.europa.eu.
In support of these innovations, the EMA have also reminded users of the training available to EV WEB users and announced the publication of a new EudraVigilance training plan and training page:
The EudraVigilance Training plan will provide information on the training curriculum that has been developed to prepare stakeholders on the changes introduced by the ‘EudraVigilance Auditable Requirements’ project in the EudraVigilance system.
The publication of the dedicated EudraVigilance training page will provide stakeholders with details on the current training offering and links to the upcoming training modules which will be published over the course of 2016 and early 2017.
Link to EudraVigilance training plan is here.
Link to EudraVigilance training page is here.