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EMA – DARWIN EU® welcomes first data partners (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022)

EMA has selected the first set of data partners to collaborate with DARWIN EU®, the Data Analysis and Real-World Interrogation Network.

The data available to these partners will be used for studies to generate real-world evidence that will support scientific evaluations and regulatory decision making; one of the three initial studies, of particular interest to the cell and gene therapy community, is focused on the epidemiology of rare blood cancers to inform on their prevalence in Europe.

Real-world evidence refers to information derived from analysis of real-world data, which is routinely collected data about a patient’s health status or delivery of healthcare from a variety of sources other than traditional clinical trials.

Please find details here.

See all of Catapult’s Regulatory Round-up for November 2022 here. Published on the 8th of December 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (25 janvier 2023). EMA – DARWIN EU® welcomes first data partners (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022). ELSIBI. Consulté le 5 mars 2026 à l’adresse https://doi.org/10.58079/o67h


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