EMA Undertook 14 RWE Studies In 2018 To Complement Company Data
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.
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The generation of more real world evidence on medicines is one of the aims of a newly announced collaboration that will see family doctors playing a bigger role in providing data for the European Medicines Agency to use in its drug evaluation activities.
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.
Saudi Arabia has explained what information on a drug’s review will be made public following a marketing authorization decision.