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Joint HMA/EMA task force on big data established
To further evaluate the role of Big Data in the healthcare system, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have established a new task force on Big Data. The group, which is headed by the Dutch Medicines Agency and EMA, will be exploring how medicines regulators in the European Economic Area (EEA) can use big data to support research, innovation and robust medicines development to benefit both human and animal health.
Within the next 18 month the task force will be working on establishing a roadmap and recommendations for the use of Big Data in the assessment of medicines. Preparatory work will include the mapping of sources and characteristics of big data and the exploration of the potential applicability and impact of big data on medicines regulation. The task force will also collaborate with other regulatory authorities and partners outside the EEA to consider their insights on big data initiatives.
Once the work is concluded the task force is planning to present a roadmap for the development of big data capabilitiesfor the evaluation of applications for marketing authorisations or clinical …
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Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.