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.
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Pharmacoepidemiologists and statisticians at the European Medicines Agency used databases of electronic healthcare records to support decision-making by its scientific committees using real-world evidence.