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.
The Danish Medicines Agency has announced plans to establish a first-of-its-kind data analysis center within its premises by the end of this year with the ability to analyze raw data in the pre-market phase and to scrutinize a variety of real-world data sources in the post-marketing stage, covering both drugs and medical devices.
When the center achieves full functionality, the Danish agency says it will become the first EU national competent authority to...
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