Friday, March 30, 2018
As a result of successful collaboration with national CF registries and extensive interaction with the European Medicine Agency (EMA), the ECFS Patient Registry has been qualified by the EMA as an appropriate platform for the collection of CF data for Post Authorisation Safety Studies and Post Authorisation Efficacy studies. These studies support regulatory decision making for medicines used in the treatment of CF. 
As a last step in the qualification process, a "Context of Use" document, describing the regulatory view, is available for public consultation on the EMA website.  A report on the CF Registries workshop Initiative for Patients, organised by EMA, is available here