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. 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

  4. 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

  5. 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

  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. Published

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

    Møllebæk, Mathias, 2024.

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

  8. 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

  9. 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

  10. 2023
  11. 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

  12. Published

    The therapeutic potential of psychedelics: the European regulatory perspective

    Butlen-Ducuing, F., McCulloch, D. E. W., Haberkamp, M., Mattila, T., Bałkowiec-Iskra, E., Aislaitner, G., Balabanov, P., Lundberg, J., Stenbæk, Dea Siggaard, Elferink, A., Knudsen, Gitte Moos & Thirstrup, Steffen, 2023, In: The Lancet. 401, 10378, p. 714-716 3 p.

    Research output: Contribution to journal › Comment/debate › Research › peer-review

  13. 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

  14. 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

  15. Published

    Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan

    Hino, Y., Okada, M., Hallgreen, Christine Erikstrup, De Bruin, M. L., Doty, R. E., Matsumaru, N. & Tsukamoto, K., 2023, In: Biological and Pharmaceutical Bulletin. 46, 5, p. 700-706

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

  16. Published

    Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts

    Hogervorst, M. A., Møllebæk, Mathias, Vreman, R. A., Lu, T. A., Wang, J., De Bruin, M. L., Leufkens, H. G. M., Mantel-Teeuwisse, A. & Goettsch, W., 2023, In: BMJ Open. 13, 8, 11 p., e072309.

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

  17. Published

    Paper Tigers in the Clinic? Rhetorical Argument Fields in Health Policy Implementation

    Møllebæk, Mathias, 2023, Rhetorical Argumentation: The Copenhagen School: Windsor Studies in Argumentation. Kock, C. & Lantz, M. (eds.). Windsor, ON, Vol. 13. p. 408-433

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

  18. 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

  19. 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

  20. 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

  21. 2022
  22. Published

    Investigation of the potential association between the use of fluoxetine and occurrence of acute pancreatitis: a Danish register-based cohort study

    Aakjær, Mia, Kristiansen, S. B., Pape, K., Sessa, Maurizio, Dalhoff, Kim, De Bruin, M. L. & Andersen, Morten, 2022, In: International Journal of Epidemiology. 51, 5, p. 1656–1665

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

  23. Published

    Serious arrhythmia in initiators of citalopram, escitalopram, and other selective serotonin reuptake inhibitors: A population-based cohort study in older adults

    Aakjær, Mia, Werther, S. K., De Bruin, M. L. & Andersen, Morten, 2022, In: Clinical and Translational Science. 15, 9, p. 2105-2115

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

  24. Published

    Flash presentation: Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Valproates

    Abtahi, S., Pajouheshnia, R., Duran-Salinas, C., Riera-Arnau, J., Gamba, M., Alsina, E., Hallgreen, Christine Erikstrup, Limoncella, G., Bartolini, C., Holthuis, E., Martin-Perez, M., Brown, J., Sturkenboom, M., Klungel, O. & Lot, O., 2022, In: Drug Safety. 45, 10, p. 1312-1313

    Research output: Contribution to journal › Conference abstract in journal › Research › peer-review

  25. Published

    Regulatory authority and clinical acceptability: Physicians' responses to regulatory drug safety warnings

    Bhasale, A. L., Sarpatwari, A., Lipworth, W., Møllebæk, Mathias, McEwin, E. J., Gautam, N., Santiago Ortiz, A. & Mintzes, B. J., 2022, In: British Journal of Clinical Pharmacology. 88, 2, p. 713-722

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

  26. Published

    Guidance for pediatric use in prescription information for novel medicinal products in the EU and the US

    Christiansen, H., De Bruin, M. L., Frøkjær, Sven & Hallgreen, Christine Erikstrup, 2022, In: PLoS ONE. 17, 4, 19 p., e0266353.

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

  27. Published

    Mandatory requirements for pediatric drug development in the EU and the US for novel drugs: A comparative study

    Christiansen, Helle, De Bruin, M. L. & Hallgreen, Christine Erikstrup, 2022, In: Frontiers in Medicine. 9, 11 p., 1009432.

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

  28. Published

    Status of Planned and Ongoing Paediatric Trials Investigating COVID-19 Vaccines: A Cross-Sectional Study of Paediatric Clinical Trials Planned in Agreed PIPs and/or Registered in Clinical Trial Databases

    Christiansen, H., Thirstrup, Steffen & Hallgreen, Christine Erikstrup, 2022, In: Therapeutic Innovation & Regulatory Science. 56, p. 474–482

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

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