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How To Use Digital Technology For EU Drug Approvals

EMA To Advise On Suitability Of New Methods

 
• By Ian Schofield

Early interaction with the European Medicines Agency is recommended if companies are planning to incorporate digital technologies into their drug development plans. 

Technology_Hands
Help is at hand for those wanting to use digital tech in drug development • Source: Shutterstock

The European Medicines Agency has produced new guidance for pharmaceutical companies wanting advice on the use of digital technology-based tools in drug development and the preparation of marketing authorization applications (MAAs).

Digital technologies are increasingly being used in clinical trials, for example in monitoring patients’ clinically relevant parameters, digital remote monitoring of drug intake, and electronic patient signatures on informed consent...

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