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.
You may also be interested in...
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.
An ambitious action plan drawn by an EU task force, if implemented on a priority basis by the European Commission, could increase the EU’s capacity to advise on, assess and analyze big data.
The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells the Pink Sheet how Denmark is setting up a unique data analytics center for drugs and devices without reinventing the wheel.