EudraVigilance (EV)




EudraVigilance Expert Working Group (EV-EWG)

EudraVigilance Expert Working Group Mandate

The EudraVigilance Expert Working Group (EV-EWG) will work in an advisory capacity within the streamlined pharmacovigilance governance structure.

The mandate of the EudraVigilance Expert Working Group (EV-EWG) is as follows:

  • Elaborate policies and business requirements, draft guidance and co-ordinate aspects related to the practical implementation, operation of and access to EudraVigilance in line with the requirements of the pharmacovigilance and clinical trials legislation in support of the EMA/Member States project and Maintenance Group 1 structure for the implementation of the pharmacovigilance legislation and the Suspected Unexpected Serious Adverse Reaction (SUSAR) and Annual Safety Reporting project of the Clinical Trial System Expert Group.
  • Co-ordinate personal data protection activities in relation to pharmacovigilance in accordance with EU data protection legislation.
  • Provide input into the international standardisation work in pharmacovigilance and to facilitate a coordinated and harmonised implementation approach in the EU and at international level.
  • Elaborate guidelines and good practices related to EudraVigilance including all aspects related to data collection, quality management and data access for the purpose of pharmacovigilance and signal detection.
  • Provide input to the development, testing, implementation and validation of analytical and statistical methods and standard reports for data analysis and evaluation.
  • Support the development of business requirements, test and facilitate the implementation of new EudraVigilance system components in line with the auditable requirements of the ADR project.
  • Provide input into the update of the EudraVigilance Access Policy as a consequence of the implementation of ICH E2B (R3) and the pharmacovigilance legislation.

EudraVigilance Expert Working Group Membership

The EV-EWG membership can be summarised as follows:

  • Nine members from National Competent Authorities (NCAs) with pharmacovigilance and clinical trial expertise including one member of the Pharmacovigilance Risk Assessment Committee (PRAC) and one member of the Clinical Trial Facilitation Group (CTFG).
  • Five pharmaceutical industry and commercial sponsor experts (AESGP, EFPIA (2), EGA, EuropaBio).
  • One non-commercial sponsor organisation member (EORTC).
  • The ICH E2B Topic Leaders (EFPIA/EU).
  • One representative from Health Canada.

The co-chairs of the EudraVigilance Expert Working group are Sabine Brosch (European Medicines Agency, EU) and Anja van Haren (Medicines Evaluation Board, NL).

The Work Programme EV-EWG 2016 can be found here


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Last update: Wednesday, 16 December 2015.



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