EMA: kwalificatieadvies voor ontwerp – de Europese Patiëntregisters van de Cystic Fibrosis Society (ECFSPR)

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The European Medicines Agency has released for public consultation a draft qualification opinion of The European Cystic Fibrosis Society Patient Registry (ECFSPR).

The ECFSPR is an established disease specific patient registry that collects CF clinical data. The ECFSPR consortium requested qualification of its registry as suitable for performing pharmacoepidemiological studies for regulatory purposes concerning medicines intended for the treatment of cystic fibrosis.

The qualification opinion provides a draft context of use of the registry 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.

The draft qualification opinion is available by clicking here.

Comments should be provided using this template and sent to jane.moseley@ema.europa.eu by 09/04/2018.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

For more information on the European regulatory system for medicines, please consult our brochure.

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