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Digitalizing Risk Minimization Measures in EU: Explorative Co-design Workshops with Expert Stakeholders

Mathias Møllebæk1, Amalie Christine Bagger1, Kirstine Lund Hansen1

  • 1Copenhagen Centre for Regulatory Science, Department of Pharmacy, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark.

Therapeutic Innovation & Regulatory Science
|December 17, 2025
PubMed
Summary

Digitalizing medicines safety information in the EU offers personalized interventions but requires addressing implementation, workload, and ethical challenges. Future strategies must consider digital access and diverse information ecosystems for effective risk minimization.

Keywords:
Digital healthDigitalizationDrug regulationDrug safetyDrug safety communicationRisk minimization

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