22 March 2017 - Task force to establish roadmap and recommendations for use of big data in assessment of medicines
Together with the heads of the national competent authorities in the European Economic Area (EEA), known as Heads of Medicines Agencies (HMA), the European Medicines Agency (EMA) has established a new task force to explore how medicines regulators in the EEA can use big data to support research, innovation and robust medicines development in order to benefit human and animal health.
The term big data refers to extremely large sets of information which require specialised computational tools to enable their analysis and exploitation. These data might come from electronic health records from millions of patients, genomics, social media, clinical trials or spontaneous adverse reaction reports, to name just a few. The vast volume of data has the potential to contribute significantly to the way the benefits and risks of medicines are assessed over their entire lifecycle.