8 November 2016 - EMA workshop broadcast live on 14-15 November.
The EMA is organising a workshop on 14-15 November 2016 to identify opportunities for big data in medicines development and regulation, and to address the challenges of their exploitation. You can follow a live broadcast of the workshop by clicking on the ‘multimedia’ tab on the event page.
Big data is a term which describes the collection of extremely large sets of information which require specialised computational tools to enable their analysis and exploitation. These vast volumes of data have the capability to significantly contribute to the way the benefit-risk of medicines is assessed over the entire lifecycle. A subset of big data is real world evidence, which encompasses the use of sources such as electronic health records, registries, hospital records and health insurance data. Already used to support pharmacovigilance activities, real world evidence has the potential to support product development and the assessment of performance of a medicine on the market.