On 22 November 2017, the European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance with enhanced functionalities for reporting and analysing suspected adverse reactions.
The new system has implications for all users of the EudraVigilance system, such as National Competent Authorities, Marketing Authorisation Holders and Sponsors of clinical trials. All users have to ensure that their processes and local IT infrastructure are compatible with the new system. As the deadline approaches, SMS-oncology would like to point out the preparation process for Sponsors of clinical trials.
The main technical change to the EudraVigilance system will be the implementation of the new ISO ICSR E2B (R3) format and EU ICSR Implementation Guides. The EVWEB, the web application for the electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs), will be re-designed with the new ISO ICSR E2B (R3) format.
What should Sponsors of clinical trials do to prepare for the change?
- Continue to report SUSARs for clinical trials authorised under Directive 2001/20/EC
- Adapt processes of reporting SUSARs to be in line with the new ICH E2B(R3) format
- Ensure that users of EVWEB undertake training to become familiar with the new system
What we are doing at SMS-oncology for the change?
Members of our Pharmcovigilance team have attended the EMA’s face-to-face training days ‘The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B (R3) format’ to learn more about the new system, and to be able to submit SUSARs the correct way after November, 22nd. Currently our team is finalizing the implementation and procedural updates, accordingly. We are continuously providing refresher trainings to our safety reporting staff and checking our systems in advance of the stipulated timelines. In addition, our safety database is compliant with the EMA’s expectations (ICH E2B (R3) format) after 22 November 2017.
Detailed information about the new EudraVigilance system can be found on the EMA website.