EudraVigilance Expert Working Group

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

EV-EWG meetings take place at the European Medicines Agency (EMA) in London. The Agency also provides secretariat support for the group.

Mandate

The working group's mandate includes: 

  • 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 implementation of new EudraVigilance system components;
  • providing input into the update of the EudraVigilance access policy.

The group supports and liaises with:

For the EV-EWG's full mandate and a detailed description of its activities, see:

Composition

The EV-EWG consists of:

The group may invite additional experts depending on the specific topic to be addressed.

Members

Below are the current members of the EV-EWG in alphabetical order of surname:

  • Pascal Auriche
  • Delphine Bertram
  • Sabine Brosch
  • Maria Luisa Casini
  • Nathalie Crokart
  • Veronique Demontrond
  • Bjorn Eriksson
  • Mara Ernst
  • Diane Farkas
  • Alastair Fowkes
  • Nick Halsey
  • Martin J. Henzl
  • Fatima Herji
  • Andrew Hudson
  • Wendy Huisman
  • Christoph F Kueng
  • Nicole Lang
  • Edurne Lazaro
  • Herve Le Louet
  • David J Lewis
  • Denny Lorenz
  • Subhash Mistry
  • Victoria Newbould
  • Augusto Eugenio Pardal Filipe
  • Dierk Petzold
  • Paolo Porcelli
  • Mary Raphael
  • Martina Schaeublin
  • Elke Stahl
  • Philip Tregunno
  • Anja van Haren
  • Kristina Vavruskova
  • Margaret Walters

Related content

Related documents

Important medical events list