Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda.

Autor: Maksimova MV; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands., van Thiel GJMW; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands., Tromp Y; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands., Lechner R; Department of Clinical Genetics, Erasmus Medical Center, Rotterdam, Netherlands., van Delden JJM; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands., Bloem LT; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.

Publikováno v: Frontiers in medicine [Front Med (Lausanne)] 2024 Jun 24; Vol. 11, pp. 1408553. Date of Electronic Publication: 2024 Jun 24 (Print Publication: 2024).

Experiences and perceptions of continuous deep sedation: An interview study among Dutch patients and relatives.

Autor: Jonker LA; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.; Department of Pediatrics, Diakonessenhuis Utrecht, Utrecht, The Netherlands., Heijltjes MT; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands., Rietjens JAC; Department of Public Health, Erasmus Medical Center, Erasmus University, Rotterdam, The Netherlands.; Department of Design, Organization and Strategy, Faculty of Industrial Design Engineering, Delft University of Technology, Delft, The Netherlands., van der Heide A; Department of Public Health, Erasmus Medical Center, Erasmus University, Rotterdam, The Netherlands., Hendriksen G; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands., van Delden JJM; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands., van Thiel GJMW; Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.

Publikováno v: Health expectations : an international journal of public participation in health care and health policy [Health Expect] 2024 Feb; Vol. 27 (1), pp. e13869. Date of Electronic Publication: 2023 Oct 11.

The reimbursement for expensive medicines: stakeholder perspectives on the SMA medicine nusinersen and the Dutch Coverage Lock policy.

Autor: Scheijmans FEV; Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. f.e.v.scheijmans@umcutrecht.nl.; University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands. f.e.v.scheijmans@umcutrecht.nl.; Department of Public Health, Healthcare Innovation & Evaluation and Medical Humanities, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands. f.e.v.scheijmans@umcutrecht.nl., Zomers ML; University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.; Department of Public Health, Healthcare Innovation & Evaluation and Medical Humanities, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands., Fadaei S; University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.; Department of Public Health, Healthcare Innovation & Evaluation and Medical Humanities, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands., Onrust MR; University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.; Department of Public Health, Healthcare Innovation & Evaluation and Medical Humanities, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands., van der Graaf R; University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.; Department of Public Health, Healthcare Innovation & Evaluation and Medical Humanities, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands., Delden JJMV; University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.; Department of Public Health, Healthcare Innovation & Evaluation and Medical Humanities, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands., van der Pol WL; Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.; University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands., van Thiel GJMW; University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.; Department of Public Health, Healthcare Innovation & Evaluation and Medical Humanities, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands.

Publikováno v: BMC health services research [BMC Health Serv Res] 2022 Nov 04; Vol. 22 (1), pp. 1320. Date of Electronic Publication: 2022 Nov 04.

Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports

Autor: Bernabe, Rosemarie de la Cruz, van Thiel, GJMW, Breekveldt, NS, Gispen-de Wied, CC, Van Delden, Johannes JM

Publikováno v: Bernabe, Rosemarie de la Cruz van Thiel, GJMW Breekveldt, NS Gispen-de Wied, CC Van Delden, Johannes JM . Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports. Current Medical Research and Opinion. 2018, 1-9
Current Medical Research and Opinion

Externí odkaz: http://hdl.handle.net/10852/71900
https://www.duo.uio.no/bitstream/handle/10852/71900/4/Full%2Bversion.pdf

Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective.

Autor: de Jong AJ; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands., van Rijssel TI; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands., Zuidgeest MGP; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands., van Thiel GJMW; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands., Askin S; Regulatory Affairs Innovation, Novartis Pharma AG, Basel, Switzerland., Fons-Martínez J; The Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Valencia, Spain., De Smedt T; Global Regulatory Affairs, UCB Pharma, Brussels, Belgium., de Boer A; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.; Dutch Medicines Evaluation Board, Utrecht, The Netherlands., Santa-Ana-Tellez Y; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands., Gardarsdottir H; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.; Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.; Faculty of Pharmaceutical Sciences, University of Iceland, Reykjavik, Iceland.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2022 Aug; Vol. 112 (2), pp. 344-352. Date of Electronic Publication: 2022 May 17.