Qualification opinion - The European Cystic Fibrosis Society Patient Registry (ECFSPR)

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Document details

Download document Qualification opinion - The European Cystic Fibrosis Society Patient Registry (ECFSPR)
Reference number EMA/CHMP/SAWP/802259/2017
Status draft: consultation open
First published 2018-02-09
Last updated 2018-02-09
Consultation start date 2018-02-09
Consultation end date 2018-04-09
Email address for submissions jane.moseley@ema.europa.eu

Summary

This report provides a draft context of use for public consultation describing where this registry is deemed by CHMP as an appropriate data source for post-authorisation studies to support regulatory decision making on medicines for the treatment of cystic fibrosis, together with CHMP's response to the questions posed by the Consortium.