Copenhagen Centre for Regulatory Science

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  1. 2018
  2. 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

  3. 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

  4. 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

  5. 2017
  6. 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

  7. 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

  8. 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

  9. Published

    Practical Points to Address Uncertainties in Risk Management Planning

    Shakir, S., Bloem, L., De Bruin, M. L., Hoekman, J., Leufkens, H. & Ryan, P., Aug 2017, p. 458-459.

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

  10. 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

  11. Published

    Infradiaphragmatic irradiation and high procarbazine doses increase colorectal cancer risk in Hodgkin lymphoma survivors

    van Eggermond, A. M., Schaapveld, M., Janus, C. P., de Boer, J. P., Krol, A. D., Zijlstra, J. M., van der Maazen, R. W., Kremer, L. C., van Leerdam, M. E., Louwman, M. W., Visser, O., De Bruin, M. L., Aleman, B. M. & van Leeuwen, F. E., 25 Jul 2017, In: B J C. 117, 3, p. 306-314 9 p.

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

  12. 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., 1 Jan 2017, In: Frontiers in Medicine. 4, FEB, 228.

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

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