EMA report on the Big Data Workshop

Posted on 06/03/2017

The EMA said:

"Technological advances in both science and information technology are generating ever-increasing amounts of data on health and medicines. The objective of this workshop was to increase understanding of how big data will impact on our understanding of disease and facilitate medicines development, so that the regulatory community can identify opportunities and address challenges in its use for medicines decision-making. In his opening remarks, Professor Guido Rasi (Executive Director, EMA) emphasised the clear potential of big data to benefit patients.

"However, it is challenging to incorporate these data in a meaningful way into routine regulatory decision-making and importantly to understand how to determine whether the conclusions and associations arising from multiple analyses across varied data sets are causal and not simply spurious coincidence. Workshop participants included patient representatives, healthcare professionals, and representatives from government, industry, and academia, as well as regulators from across the globe."