2023 marked significant progress in the transformation to data-driven regulation continued, in line with the Network Strategy to 2025 and BDSG workplan. The fourth BDSG workplan was published in July 2023 to progress the activities launched in 2020 and to address new topics.
This report is based on the third BDSG workplan and provides a summary of the key activities and achievements of the BDSG in 2023.
The Phase II report of the HMA-EMA joint Big Data Task Force (BDTF) and the proposal to establish a joint BDSG (superseding the Big Data Task Force) were endorsed by the Heads of Medicines Agencies (HMA) in November 2019 and EMA Management Board (EMA MB) in December 2019. The BDSG was established to advise HMA and EMA MB on the recommendations of the Big Data Task Force, covering human and veterinary medicines. The full mandate of BDSG can be found here. In 2023 the BDSG met eight times virtually and one time in person.
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