EU ‘Big Data’ Report: Big Opportunities

EU ‘Big Data’ Report: Big Opportunities – And Big Challenges

EU regulators have produced the first fruits of their ambitious “big data” project aimed at ensuring that the EU drug regulatory system can make full use of the rapidly increasing volume and complexity of data being gathered across multiple settings in the healthcare area.

Big data will play a key role in regulatory procedures for developing, evaluating and monitoring the safety and effectiveness of medicines, medical devices and combinations of the two, and without it many future regulatory activities will not be possible.

However, many hurdles must still be overcome in areas like data access, transfer, interoperability and quality, and without a coordinated...