EMA, HTA Bodies & Payers Explore Common Ground On Use Of RWE
A technical workshop is planned for later this year to identify common “use cases” for real-world evidence that are important to the European Medicines Agency, health technology assessment bodies and payers.
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The EU’s big data steering group has laid out some ambitious proposals for integrating real-world evidence into regulatory decision making, as well as plans for ongoing engagement on the use and analysis of RWE with industry and other stakeholders.
The latest meeting of the DARWIN EU advisory board heard about moves to increase the number of RWD sources that can be analyzed and to improve the efficiency of performing RWE studies.
An EU-wide network of real-world data sources will aim to become the dominant vehicle for delivering such evidence to the EMA and member countries, who have until now been using a wide range of different sources to access such data.