Copenhagen Centre for Regulatory Science

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  1. Published

    A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making

    Coppens, D. G. M., de Wilde, S., Guchelaar, H. J., De Bruin, M. L., Leufkens, H. G. M., Meij, P. & Hoekman, J., 2018, In: Cytotherapy. 20, 6, p. 769-778 10 p.

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

  2. Published

    Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation

    Coppens, D. G. M., De Bruin, M. L., Leufkens, H. G. M. & Hoekman, J., Jan 2018, In: Clinical Pharmacology and Therapeutics. 103, p. 120-127

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

  3. Published

    Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries

    Coppens, D. G. M., Gardarsdottir, H., De Bruin, M. L., Meij, P., Leufkens, H. G. M. & Hoekman, J., Aug 2020, In: Regenerative Medicine. 15, 8, p. 2015-2028 14 p.

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

  4. Published

    A decade of marketing approval of gene and cell based therapies in the United States, European Union, and Japan: A regulatory decision-making evaluation

    Coppens, D. G. M., de Wilde, S., Guchelaar, H. J., De Bruin, M. L., Leufkens, H. G. M., Meij, P. & Hoekman, J., 2018, In: Pharmacoepidemiology and Drug Safety. 27, S2, p. 517-517

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

  5. Published

    Publication rates and reported results in a cohort of gene-and cell-based therapy trials

    Coppens, D. G. M., Gardarsdottir, H., Van Den Bogert, C. A., De Bruin, M. L., Leufkens, H. G. M. & Hoekman, J., 2020, In: Regenerative Medicine. 15, 1, p. 1215-1227 13 p.

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

  6. Published

    Impact of European Benefit-Risk reassessment procedures on drug prescribing practices in Denmark

    De Bruin, M. L. (., Hallgreen, Christine Erikstrup & Andersen, Morten, Aug 2019.

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

  7. Published

    A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways

    Druedahl, Louise C., Almarsdóttir, Anna Birna, Kälvemark Sporrong, Sofia, De Bruin, M. L., Hoogland, H., Minssen, Timo, van de Weert, Marco, Kesselheim, A. S. & Sarpatwari, A., 2020, In: Nature Biotechnology. 38, 11, p. 1253-1256 4 p.

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

  8. Published

    Evolving biosimilar clinical requirements: A qualitative interview study with industry experts and European national medicines agency regulators

    Druedahl, Louise C., Kälvemark Sporrong, Sofia, van de Weert, Marco, De Bruin, M. L. (., Hoogland, H., Minssen, Timo & Almarsdóttir, Anna Birna, 2021, In: BioDrugs. 35, p. 351-361

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

  9. 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

  10. 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

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