Copenhagen Centre for Regulatory Science

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  1. 2022
  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Published

    Marketing authorization pathways and clinical evidence supporting approval of orphan medicinal products in EU between January 2015 and October 2021

    Hallgreen, Christine Erikstrup, Møllebæk, Mathias & Corap, E., 2022, In: Pharmacoepidemiology and Drug Safety. 31, S2, p. 266-267

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

  9. Published

    Challenges in qualitative social pharmacy research: Reflections based on a conference workshop

    Kälvemark Sporrong, Sofia, Kaae, Susanne, Nørgaard, Lotte Stig, Møllebæk, Mathias, Waaseth, M., Cantarero Arevalo, Lourdes, Persson, C. L., Bekker, C. L., Lindell, Johanna Falby & Druedahl, Louise C., 2022, In: Research in Social and Administrative Pharmacy. 18, 1, p. 2254-2258

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

  10. Published

    Methodological and disciplinary competence and insecurity in qualitative research

    Kälvemark Sporrong, Sofia, Kaae, Susanne, Nørgaard, Lotte Stig, Møllebæk, Mathias, Cantarero Arevalo, Lourdes, Druedahl, Louise C., Waaseth, M., Ljungberg Persson, C., Bekker, C. L. & Lindell, Johanna Falby, 2022, Contemporary research methods in pharmacy and health services. Desselle, S. P., Garcia-Cárdenas, V., Anderson, C., Aslani, P., Chen, A. M. H. & Chen, T. F. (eds.). 1 ed. Academic Press, p. 567-574

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

  11. Published

    Mod en hverdagsetik for lægemiddelbrug: Towards an everyday ethics for medicines use: About people, medicines and multiplicity

    Lau, Sofie Rosenlund & Møllebæk, Mathias, 2022, In: Tidsskrift for Forskning i Sygdom og Samfund. 19, 37, p. 19-41 22 p.

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

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