Copenhagen Centre for Regulatory Science

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  1. Published

    Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

    Druedahl, Louise C., Kälvemark Sporrong, Sofia, Minssen, Timo, Hoogland, H., De Bruin, M. L. (., van de Weert, Marco & Almarsdóttir, Anna Birna, 2022, In: PLOS One. 17, 1, p. 1-13 13 p.

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

  2. Published

    Medicines authority regulators and industry perspectives on the European regulation of biosimilars

    Druedahl, Louise C., De Bruin, M. L. (., van de Weert, Marco, Minssen, Timo, Hoogland, H. & Almarsdóttir, Anna Birna, 2019.

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

  3. Published

    MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY

    Druedahl, Louise C., De Bruin, M. L., Hoogland, H., Minssen, Timo, van de Weert, Marco, Kälvemark Sporrong, Sofia & Almarsdóttir, Anna Birna, Dec 2019, p. E45-E46.

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

  4. Published

    ELSI Implications of Prioritizing Biological Therapies in the Times of COVID-19

    Druedahl, Louise C., Lebret, Audrey & Minssen, Timo, Oct 2020, In: Journal of Law, Medicine & Ethics. 48, 3, p. 579-582

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

  5. 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

  6. Published

    Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight

    Engel, P., Almas, M. F., De Bruin, M. L., Starzyk, K., Blackburn, S. & Dreyer, N. A., 2017, In: British Journal of Clinical Pharmacology. 83, 4, p. 884-893 10 p.

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

  7. Published

    Media coverage of drug regulatory agencies' safety advisories: A case study of citalopram and denosumab

    Fabbri, A., O'Keeffe, M., Moynihan, R., Møllebæk, Mathias, Mohammad, A., Bhasale, A., Puil, L. & Mintzes, B., 2020, In: British Journal of Clinical Pharmacology. 86, 7, p. 1416-1429

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

  8. Published

    Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMA

    Fanø, A. B., Møllebæk, Mathias & Kaae, Susanne, May 2020, In: Therapeutic Innovation & Regulatory Science. 54, 3, p. 631-639

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

  9. Published

    Comparisons of direct and indirect utilities in adult epilepsy populations: A systematic review

    Foster, E., Chen, Z., Ofori-Asenso, R., Norman, R., Carney, P., O'Brien, T. J., Kwan, P., Liew, D. & Ademi, Z., 2019, In: Epilepsia. 60, 12, p. 2466-2476 11 p.

    Research output: Contribution to journal › Review › Research › peer-review

  10. Published

    How to Measure the Impact of Pharmacovigilance Activities on Public Health?

    Gardarsdottir, H., Kant, A., De Bruin, M. L., Hallgreen, Christine Erikstrup, Dal Pan, G. & Way, D., Aug 2017, p. 31-31.

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

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