EMA Works On Defining Metadata From RWD Sources
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.
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EU regulators have developed a draft good practice guide explaining how stakeholders can make use of the Metadata Catalog of RWD Sources, which is expected to be released in late 2023, to identify appropriate sources for specific research questions.
A panel of regulators overseeing the implementation of several big data projects within the EU medicines network has given details of real-world evidence integration pilots to be undertaken next year by various European Medicines Agency scientific committees.
An EU group has listed several ambitious projects to help EU regulators realize their cherished vision of using big data capabilities to support innovation and public health. But these proposals may take a backseat as COVID-19-related challenges continue.