Cystic fibrosis workshop - Registries initiative

Date: 14/06/2017
Location: European Medicines Agency, London, UK
The EMA's initiative for patient registries explores ways of expanding the use of patient registries in the benefit-risk evaluation of medicines within the European Economic Area. The participants of the workshop on cystic fibrosis registries included representatives from the European CF Society Patient Registry, national CF registries, marketing authorisation holders, health technology assessment, national competent authorities, and the EMA. The workshop objectives were to agree on implementable recommendations on the core data elements to be collected in registries, protocols, consents, governance and registry interoperability and on the actions needed from the stakeholder groups to advance registry use in supporting regulatory benefit-risk evaluations.

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