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EMA Big Data Steering Group 2022 report now available

The 2022 report of the European Medicines Agency’s Big Data Steering Group (BDSG) is now available. The BDSG was established in 2019 to provide the EMA Management Board and the HMA with guidance based on the recommendations of the Big Data Task Force. Key activities of the BDSG from 2022 include:

  • Real-world generation pilots with EMA committees
  • Launch of the public consultation for the first draft EU Data Quality Framework for medicine regulation
  • Publication of the first metadata list for real-world data sources and studies to improve discoverability of data sources and real-world studies

In terms of rare diseases, one major success of the BDSG’s 2022 activities was the appointment and establishment of the DARWIN EU ® coordination centre. DARWIN EU ®, the Data Analysis and Real-World Interrogation Network, will conduct studies using real-world data to help support a range of EMA scientific committees. Among the first of these studies to be initiated is a study on the prevalence of rare blood cancers in Europe in support of COMP activities. Moving forward, DARWIN EU ® is expected to provide new opportunities for the transnational use of health data to develop new policies and strengthen personalised medicine.

Read more about it here.


OpenEdition vous propose de citer ce billet de la manière suivante :
bartosb (24 mai 2023). EMA Big Data Steering Group 2022 report now available. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o6bv


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