EU Panel Sets Ambitious Big Data Workplan
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.
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EMA Lays Out Plans For Routine Use Of Real-World Evidence
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.
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.
EMA Takes A Dive Into Patient-Level Data
The European Medicines Agency will begin a pilot in 2021 to examine the practical aspects of undertaking patient-level data assessments during medicines evaluation and identify scenarios when such assessments might be useful.