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Mandate of ENCePP Working Group 3

Scope Inventory of EU data sources and methodological
approaches for multi-source studies
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Chair:
Rapporteur(s): ENCIAG:
Miriam Sturkenboom
Jim Slattery (European Medicines Agency), Stefanie Prilla (European Medicines Agency)
Dr Francisco de Abajo Iglesias, Dr Tjeerd Van Staa
Mandate
  • EU inventory of data sources
    - Define the elements that the EU inventory of data sources should have, according to different categories (e.g. databases, disease registries, exposed registries, case-control surveillanc)
    - Identify existing data sources useful for PE and PV research
    - Identify relevant areas of PE and PV not covered by the existing data sources in the EU
    - Explore ways to stimulate and support initiatives to create new data sources in EU Member States
  • Approaches & processes for interoperability and sharing of European epidemiology data sources
    - Discuss operational approaches for organising, initiating and performing of observational safety studies through ENCePP, as well as large simple randomised clinical trials
    - Explore ways of performing multi-source studies (e.g. combining data, using common protocols)
    - Develop training programs
  • Data privacy restrictions for PE/PV research
    - Develop approaches to overcome differences in national legislation on data privacy in order to facilitate multi-national database studies, taking into account legal advice
    - Develop common rules to protect patients’ and providers’ rights with respect to data confidentiality
  • Input to the design of the European Medicines Agency web page