Data from patient registries to replace clinical trials in previously untreated haemophilia patients

30 November 2018 - EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications ...

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EMA seeks feedback on using registries for regulatory purposes

15 November 2018 - The EMA is seeking feedback on the use of patient disease registries for regulatory purposes.  ...

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Quality assurance of registries for health technology assessment

25 September 2018 - The aim of this study was to identify guidelines and assessment tools used by health technology agencies ...

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EMA report makes recommendations for CAR-T patient registries

22 May 2018 - A new report from the EMA lays out recommendations for improving the use of patient registries ...

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Collecting high-quality information on medicines through patient registries

12 October 2015 - The European Medicines Agency (EMA) has launched an initiative on patient registries aimed at making better use ...

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