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Big Data In Medicines Regulation Will Need ‘Considerable Change In Mindset’

 
• By Maureen Kenny

Changing mindsets, technologies outpacing regulatory frameworks, intense international collaboration, and the future of the randomized controlled clinical trial. Big data is forcing us to think big, senior European regulator Thomas Senderovitz tells the Pink Sheet.

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Proposals on the use of big data in drug evaluation are under development • Source: Shutterstock

"A considerable change in mindset across the board" will be needed in a new era of drug development where precision medicine, real-world data gathering and the use of big data are the norm. That’s the view of Thomas Senderovitz, Danish Medicines Agency head and until recently chair of the joint Heads of Medicines Agencies/European Medicines Agency Big Data Task Force.

Big data is not the only driver. The fast pace of change and convergence of technologies are also key, says...

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