Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features
EventHumanPharmacovigilance
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Date
- fredag, 29 november 2019, Hela dagen
Plats
- European Medicines Agency, Amsterdam, the Netherlands
The aim of the workshop is to investigate the feasibility of using disease registries for cancer therapies based on genetic and molecular features.
The objectives are to agree on:
- core data elements that should be collected in cancer registries to support regulatory assessment of long term safety and effectiveness of new cancer treatments;
- quality assurance measures necessary to ensure registry data are of suitable quality to support regulatory evaluation and to permit registries interoperability;
- practical considerations for accessing and sharing data to be used for regulatory purposes.