HMA/EMA TASK FORCE ON BIG DATA

HMA/EMA TASK FORCE ON BIG DATA

blished on 13 February 2019 a summary report on the main outputs and achievement of the task force. In preparing the report, it assessed the generation of “Big data”, their relevant resources and main formats, the methods for processing and analysing big data and the current state of expertise across the European medicines regulatory framework.

Moreover, recommendations for a path towards understanding the acceptability of evidence derived from “Big data” in support of the evaluation and supervision of medicines by regulators were included in the report. While the recommendations and associated actions set out what needs to be addressed, the mechanisms by which this may be achieved requires further focused work over the coming year.

Massive amounts of data are generated on a daily basis through wearable devices, electronic health records, social media, clinical trials or spontaneous adverse reaction reports. There is no doubt that insights derived from this data will increasingly be used by regulators to assess the benefit-risk of medicines across their whole lifecycle. However, in order to benefit from and make prudent use of the data collected, regulators need a deeper understanding of the data landscape.

From the need to recognize the importance of using health data and the necessity to have the proper tools to collect health data in order to increase knowledge in the field of medical research, a specific TEDDY Network Working Group on Health Data arose, with the aim to promote data collection, data sharing and data storing for secondary use.

Further information on this working group are available here.

The HMA – EMA Joint Big Data taskforce is composed of representatives from 14 National Competent Authorities (NCAs) plus EMA representation and until February 2018 was chaired by Thomas Senderovitz, Danish Medicines Agency and Alison Cave, EMA. From February 2018, Nikolai Brun of the Danish Medicines Agency replaced Thomas Senderovitz as Chair of the taskforce.

Stakeholders and members of the public are invited to submit their comments on the core recommendations in the summary report (not to exceed 1,000 words) to bigdatasec@dkma.dk until 15 April 2019.

More information can be found here.

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