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.
HumanPharmacovigilance
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 dataprotection 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:
Members
Below are the current members of the EV-EWG in alphabetical order of surname: