How To Use Digital Technology For EU Drug Approvals
BY IAN SCHOFIELD Executive Summary Early interaction with the European Medicines Agency is recommended if companies are planning to incorporate digital technologies into their drug development plans.
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 forms. Technologies that might be used include sensors (ingestibles and implantables), mobile health tools such as wearables for remote patient monitoring, video consultations with patients, health data analytics and digital record systems.
6 / September 2020
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