Copenhagen Centre for Regulatory Science

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  1. 2017
  2. Published

    Risk Factors Associated with Post-Marketing Changes in Specific Obligations of Conditionally Authorised Products in the EU

    Bloem, L. T., Mantel-Teeuwisse, A. K., Leufkens, H. G. M., De Bruin, M. L., Klungel, O. H. & Hoekman, J., Aug 2017, p. 605-605.

    Research output: Contribution to conference › Conference abstract for conference › Research

  3. Published

    Cancer risk among insulin users: comparing analogues with human insulin in the CARING five-country cohort study

    But, A., De Bruin, M. L., Bazelier, M. T., Hjellvik, V., Andersen, Morten, Auvinen, A., Starup-Linde, J., Schmidt, M. K., Furu, K., de Vries, F., Karlstad, Ø., Ekström, N. & Haukka, J., Sep 2017, In: Diabetologia. 60, 9, p. 1691-1703

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

  4. Published

    Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013

    Bouvy, J. C., Blake, K., Slattery, J., De Bruin, M. L., Arlett, P. & Kurz, X., Dec 2017, In: Pharmacoepidemiology and Drug Safety. 26, 12, p. 1442-1450

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

  5. 2018
  6. 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

  7. 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

  8. Published

    Evidence Synthesis in Harm Assessment of Medicines Using the Example of Rosiglitazone and Myocardial Infarction

    Rietbergen, C., Stefansdottir, G., Leufkens, H. G., Knol, M. J., De Bruin, M. L. & Klugkist, I., 2018, In: Frontiers in Medicine. 4, 12 p., 228.

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

  9. Published

    The association of diabetes mellitus and insulin treatment with expression of insulin-related proteins in breast tumors

    Bronsveld, H. K., De Bruin, M. L., Wesseling, J., Sanders, J., Hofland, I., Jensen, V., Bazelier, M. T., ter Braak, B., de Boer, A., Vestergaard, P. & Schmidt, M. K., 2018, In: BMC Cancer. 18, 11 p., 224.

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

  10. 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

  11. Published

    When More Is Less: An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection

    Klein, K., Scholl, J. H. G., De Bruin, M. L., van Puijenbroek, E. P., Leufkens, H. G. M. & Stolk, P., Feb 2018, In: Clinical Pharmacology and Therapeutics. 103, p. 296-303

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

  12. Published

    EU decision-making for marketing authorization of advanced therapy medicinal products: a case study

    de Wilde, S., Coppens, D. G. M., Hoekman, J., de Bruin, M. L., Leufkens, H. G. M., Guchelaar, H. & Meij, P., Jul 2018, In: Drug Discovery Today. 23, 7, p. 1328-1333

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

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