Copenhagen Centre for Regulatory Science

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  1. 2024
  2. Submitted

    Medicines safety information from regulators in clinical practice guidelines: a mixed-method case study

    Andersen, A., Møllebæk, Mathias & Almarsdóttir, Anna Birna, 27 Feb 2024, (Submitted) In: Journal of Pharmaceutical Health Services Research.

    Research output: Contribution to journal › Journal article › Research › peer-review

  3. Submitted

    Challenges in the implementation of EU risk minimization measures for medicinal products in clinical practice guidelines: mixed methods multi-case study

    Møllebæk, Mathias, Gardarsdottir, H., Bikou, A., Kodrič, A., Silva , A. M., Andersen, A., Kontogiorgis, C., Poplavska, E., Ahmadizar, F., Dermiki-Gkana, F., Rutkovska, I., Ribeiro-Vaz , I., Kos, M., Sousa Ferreira, P. B., Grupstra , R., Alves, T. L. & Almarsdóttir, Anna Birna, 4 Feb 2024, (Submitted) In: Drug Safety.

    Research output: Contribution to journal › Journal article › Research › peer-review

  4. In preparation

    Developing and updating clinical practice guidelines in the European Union: Exploring governance and work processes in six member states

    Møllebæk, Mathias, Almarsdóttir, Anna Birna, Bikou, A., Kodrič, A., Andersen, A., Kontogiorgis, C., Poplavska, E., Ahmadizar, F., Dermiki-Gkana, F., Rutkovska, I., Ribeiro-Vaz , I., Kos, M., Sousa Ferreira, P. B., Grupstra , R., Alves, T. L. & Almarsdóttir, Anna Birna, 2024, (In preparation) In: Health Policy.

    Research output: Contribution to journal › Journal article › Research › peer-review

  5. Published

    Drug Repurposing in Crohn's Disease Using Danish Real-World Data

    Shakibfar, Saeed, Allin, K. H., Jess, T., Barbieri, M. A., Battini, V., Simoncic, E., Kirchgesner, J., Ulven, Trond & Sessa, Maurizio, 2024, In: Pragmatic and observational research. 15, p. 17-29

    Research output: Contribution to journal › Journal article › Research › peer-review

  6. In preparation

    Early access approaches to the regulation of medicines

    Møllebæk, Mathias, 2024, (In preparation) Handbook of Global Pharmaceutical and Society Studies. Edward Elgar Publishing

    Research output: Chapter in Book/Report/Conference proceeding › Encyclopedia chapter › Research › peer-review

  7. Accepted/In press

    Information Sources for Drug Safety and Communicating Risks in Clinical Practice

    Tong, V., Møllebæk, Mathias & Aslani, P., 2024, (Accepted/In press) Principles and Practice of Pharmacovigilance and Drug Safety. Jose, J., Cox, A. R. & Paudyal, V. (eds.). Springer

    Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review

  8. Submitted

    Targeting with digital biomarkers and digital therapeutics: Epistemic and regulatory shifts

    Møllebæk, Mathias, 2024, (Submitted).

    Research output: Contribution to conference › Conference abstract for conference › Research › peer-review

  9. In preparation

    The Work 'Digital' Does in Pharmaceutical Markets

    Milne, G., Traulsen, Janine Marie & Møllebæk, Mathias, 2024, (In preparation) Science and Technology Studies (STS) Handbook of Global Pharmaceutical, Biotherapeutics and Society Studies.. Douglas, C., Geiger, S., Kleinhout-Vliek, T., Martin, P. & Wadmann, S. (eds.). Edward Elgar Publishing

    Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review

  10. 2023
  11. In preparation

    Clinical evidence and use of extrapolation in European biosimilar marketing authorizations

    Druedahl, Louise C., Vive Nielsen, C. & Hallgreen, Christine Erikstrup, 2023, (In preparation) In: BioDrugs.

    Research output: Contribution to journal › Journal article › Research › peer-review

  12. Published

    Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study

    Abtahi, S., Pajouheshnia, R., Durán, C. E., Riera-Arnau, J., Gamba, M., Alsina, E., Hoxhaj, V., Andersen, M., Bartolini, C., Kristiansen, S. B., Brown, J., Hallgreen, C. E., Garcia-Poza, P., Gardarsdottir, H., Gini, R., Girardi, A., Holthuis, E., Huerta, C., Ibánez, L., Limoncella, G. & 8 others, Martín-Pérez, M., Paoletti, O., Roberto, G., Souverein, P., Swart, K. M. A., Wing, K., Sturkenboom, M. & Klungel, O., 2023, In: Drug Safety. 46, 7, p. 689-702

    Research output: Contribution to journal › Journal article › Research › peer-review

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