Mandatory requirements for pediatric drug development in the EU and the US for novel drugs—A comparative study

Autor: Helle Christiansen, Marie L. De Bruin, Christine E. Hallgreen

Publikováno v: Frontiers in Medicine, Vol 9 (2022)

Mandatory pediatric legislation has been implemented in the European Union (EU) and the United States (US) to increase research and the availability of drugs for the pediatric population. Differences in the legislative framework can cause different p

Externí odkaz: https://doaj.org/article/76ced31c8dcb40fbbbeb8b58b790bd4c

Impact of regulatory interventions to restrict the combined use of renin–angiotensin system blockers: A Danish nationwide drug utilisation study

Autor: Richard Ofori-Asenso, Christine E. Hallgreen, Marie Louise De Bruin, Per Sindahl, Helga Gardarsdottir, Kaare Kemp

Publikováno v: British Journal of Clinical Pharmacology, 88(3), 1379. NLM (Medline)
Sindahl, P, Ofori-Asenso, R, Hallgreen, C E, Kemp, K, Gardarsdottir, H & Bruin, M L D 2022, ' Impact of regulatory interventions to restrict the combined use of renin-angiotensin system-acting agents: A Danish nationwide drug utilisation study ', British Journal of Clinical Pharmacology, vol. 88, no. 3, pp. 1379-1384 . https://doi.org/10.1111/bcp.15080

This study aimed to evaluate the impact of the risk minimisation measures issued by the European Medicines Agency in 2014 to restrict the combined use of renin-angiotensin system (RAS) agents in Denmark. Data from the Danish National Prescription Reg

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2ccd8dad0d66411d3858e1c49c582efe
https://doi.org/10.1111/bcp.15080

Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges

Autor: Marie L. De Bruin, Christine E. Hallgreen, Richard Ofori-Asenso

Publikováno v: Frontiers in Medicine
Frontiers in Medicine, Vol 7 (2020)
Ofori-Asenso, R, Hallgreen, C E & De Bruin, M L 2020, ' Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies : A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges ', Frontiers in Medicine, vol. 7, 582634 . https://doi.org/10.3389/fmed.2020.582634
Frontiers in Medicine, 7. Frontiers Media S.A.

The need to optimize drug development and facilitate faster access for patients has ignited discussions around the importance of improving interactions between health technology assessment (HTA) bodies and regulatory agencies. In this study, we condu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3b37c7dabacb13b04325541da51d9265
https://pubmed.ncbi.nlm.nih.gov/33178721

How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organizations

Autor: Lotte Stig Nørgaard, Christine E. Hallgreen, Marianne Botoft Hansen

Publikováno v: Therapeutic innovationregulatory science. 54(3)

Background: Despite increasing interest and focus on patient-centric approaches to drug development, there might still be divergent views between key stakeholders in how to perceive patient involvement and how possibly divergent views influence the r

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e1fd11e250c3d6beb6d0470e01c130d3
https://pubmed.ncbi.nlm.nih.gov/33301145

Literature review of visual representation of the results of benefit-risk assessments of medicinal products

Autor: Alex Asiimwe, Alfons Lieftucht, Georgy Genov, Deborah Ashby, Ioanna Tzoulaki, Alain Micaleff, Rebecca Noel, Richard C. Hermann, Ruth Peters, Christine E. Hallgreen, Shahrul Mt-Isa, Gerald Downey, Lawrence D. Phillips, Susan Talbot, Diana Hughes

Publikováno v: Pharmacoepidemiology and Drug Safety. 25:238-250

Background The PROTECT Benefit–Risk group is dedicated to research in methods for continuous benefit–risk monitoring of medicines, including the presentation of the results, with a particular emphasis on graphical methods. Methods A comprehensive

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::858487645ef74921d355cf0e78c76110
https://doi.org/10.1002/pds.3880