EudraVigilance Expert Working Group

The EudraVigilance Expert Working Group (EV-EWG) advises the pharmacovigilance governance structure of the European medicines regulatory network on aspects of the EudraVigilance system.

Responsibilities and composition

The working group's responsibilities include:

• developing policies and business requirements, drafting guidance and co-ordinating aspects related to implementing, operating and accessing EudraVigilance;
• co-ordinating personal data protection activities in relation to pharmacovigilance in accordance with EU data protection legislation;
• providing input into the international standardisation work in pharmacovigilance and facilitating a harmonised implementation in the EU and at international level, including support for the maintenance of the EU important medical events list ;
• developing guidelines and good practices related to data collection, quality management and data access for pharmacovigilance and signal detection;
• providing input to the development, testing, implementation and validation of analytical and statistical methods and standard reports for data analysis and evaluation;
• supporting the maintenance and further development of EudraVigilance;
• facilitating the application of the EudraVigilance access policy.

It supports and liaises with the EMA / Member States Pharmacovigilance Business Team (part of the EU's pharmacovigilance governance structure) and the Clinical Trial Facilitation Group and relevant subgroups relating to clinical trials.

The EV-EWG contains members from national competent authorities with pharmacovigilance and clinical trial expertise, pharmaceutical industry and commercial sponsors, a non-commercial sponsor organisation and other members and observers. The group may invite additional experts if required.

For more information on the EV-EWG's responsibilities, composition and procedures, see: