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Digital technologies for medicines: shaping a framework for success

Regulatory agencies can provide advice to support developers of digital technologies for medicines use, but what are the best strategies to maximize the chance of a successful regulatory interaction? Here, EMA and industry representatives comment on the experience so far.
  1. Francesca Cerreta

    1. European Medicines Agency, Amsterdam, The Netherlands.

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  2. Armin Ritzhaupt

    1. European Medicines Agency, Amsterdam, The Netherlands.

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  3. Thomas Metcalfe

    1. F.Hoffmann-La Roche, Basel, Switzerland.

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  4. Scott Askin

    1. Novartis Pharma, Basel, Switzerland.

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  5. João Duarte

    1. Alexion Europe, Levallois-Perret, France.

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  6. Michael Berntgen

    1. European Medicines Agency, Amsterdam, The Netherlands.

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  7. Spiros Vamvakas

    1. European Medicines Agency, Amsterdam, The Netherlands.

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The technological and regulatory landscape for digital technologies in medicines development and use is rapidly evolving, as they are increasingly becoming part of the conduct of clinical trials. Examples include continuous patient monitoring for clinically relevant parameters, electronic data capture of laboratory values, direct data entry by clinicians into clinical record forms and facilitated collection of patient-reported outcomes.

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Nature Reviews Drug Discovery 19, 573-574 (2020)

doi: https://doi.org/10.1038/d41573-020-00080-6

Acknowledgements

The authors acknowledge the contributions to this article of the following experts: C. Vincenzi (EMA); S. Corriol-Rohou (AstraZeneca); F. Albissola (Sanofi); S. Almeida (Medicines for Europe); M. vonFritschen (Eucope); A. Schepers (GSK), F. Ruediger (Grunenthal) and T. Chesworth (AstraZeneca).

Disclaimer

The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the organizations they are affiliated with, the European Medicines Agency or one of its committees or working parties.

Competing Interests

T.M. is employed by F. Hoffmann-La Roche and owns shares. S.A. is employed by Novartis Pharma and owns shares. J.D. is employed by Alexion and owns shares.

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