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. 2023
  7. 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

  8. 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

  9. Published

    Impact of a Treatment Guide on Intravenous Fluids in Minimising the Risk of Hospital-Acquired Hyponatraemia in Denmark

    Sindahl, Per, Overgaard-Steensen, C., Wallach-Kildemoes, H., De Bruin, M. L., Kemp, K. & Gardarsdottir, H., 2023, In: Journal of Clinical Medicine. 12, 15, 14 p., 5105.

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

  10. Published

    Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis

    Durán, C. E., Riera-Arnau, J., Abtahi, S., Pajouheshnia, R., Hoxhaj, V., Gamba, M., Alsina, E., Martin-Perez, M., Garcia-Poza, P., Llorente-Garcia, A., Gonzalez-Bermejo, D., Ibánez, L., Sabaté, M., Vidal, X., Ballarín, E., Sanfélix-Gimeno, G., Rodríguez-Bernal, C., Peiró, S., García-Sempere, A., Sanchez-Saez, F. & 22 others, Ientile, V., Ingrasciotta, Y., Guarneri, C., Tanaglia, M., Tari, M., Herings, R., Houben, E., Swart-Polinder, K., Holthuis, E., Huerta, C., Gini, R., Roberto, G., Bartolini, C., Paoletti, O., Limoncella, G., Girardi, A., Hyeraci, G., Andersen, Morten, Kristiansen, S. B., Hallgreen, Christine Erikstrup, Klungel, O. & Sturkenboom, M., 2023, In: Frontiers in Pharmacology. 14, 12 p., 1207976.

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

  11. Submitted

    Implementation of electronic distribution of Direct Healthcare Professional Communications (DHPCs) by the Danish Medicines Agency: A survey study of physicians’ experiences and preferences

    Sindahl, P., Møllebæk, Mathias, Gardarsdottir, H., De Bruin, M. L. (., Hallgreen, Christine Erikstrup & Clemmensen, M. H., 2023, (Submitted) In: Therapeutic Advances in Drug Safety.

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

  12. Published

    Machine learning-driven development of a disease risk score for COVID-19 hospitalization and mortality: a Swedish and Norwegian register-based study

    Shakibfar, Saeed, Zhao, J., Li, H., Nordeng, H., Lupattelli, A., Pavlovic, M., Sandve, G. K., Nyberg, F., Wettermark, B., Hajiebrahimi, M., Andersen, Morten & Sessa, Maurizio, 2023, In: Frontiers in Public Health. 11, 16 p., :1258840.

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

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