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.
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A two-year pilot will explore the many potential benefits that the analysis of raw data can bring to the EU drug evaluation process. These range from faster patient access to medicines, companies facing fewer questions, and better definition of the target treatment population.
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.