The Big Data Steering Group set up jointly by the European Medicines Agency (EMA) and the Heads of Medicines Agencies Organisation (HMA) published its work plan for 2022-2025 on 28 July.
The aim is to improve the integration of data analysis in health regulators’ assessments of medical products or clinical trials.
The work plan was developed based on the recommendations of the EMA-HMA joint working group published in 2020 as a conclusion to the work carried out by the joint working group between 2017 and 2019 on identifying opportunities for the use and generation of big data in medicine regulation.
The work plan is structured in tables showing, by area of work, the expected results and an indicative timetable for the progress of the work. The proposed actions include: - the objective of carrying out around 100 studies by 2025 as part of DARWIN EU, the EMA’s data and services network in Europe for better use of real-world evidence; - building a framework for data quality; - an initiative to enhance regulators’ skills with training in biostatistics, pharmacoepidemiology and data science.
The work plan covers both human and veterinary medicines.
Link to the work plan: https://aeur.eu/f/2rc (Original version in French by Emilie Vanderhulst)