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Page 1
Recommendations by the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) Working Group on preparedness of clinical trials about paediatric medicines process.
Siapkara A, Fracasso C, Egger GF, Rizzari C, Trasorras CS, Athanasiou D, Turner MA; Working Group Membership. Siapkara A, et al. Arch Dis Child. 2021 Dec;106(12):1149-1154. doi: 10.1136/archdischild-2020-321433. Epub 2021 Apr 15. Arch Dis Child. 2021. PMID: 33858819 Free PMC article. Review.
Informed consent and assent guide for paediatric clinical trials in Europe.
Lepola P, Kindred M, Giannuzzi V, Glosli H, Dehlinger-Kremer M, Dalrymple H, Neubauer D, Boylan GB, Conway J, Dewhurst J, Hoffman D. Lepola P, et al. Arch Dis Child. 2022 Jun;107(6):582-590. doi: 10.1136/archdischild-2021-322798. Epub 2021 Dec 1. Arch Dis Child. 2022. PMID: 34853000 Free PMC article.
Informed consent for paediatric clinical trials in Europe.
Lepola P, Needham A, Mendum J, Sallabank P, Neubauer D, de Wildt S. Lepola P, et al. Arch Dis Child. 2016 Nov;101(11):1017-1025. doi: 10.1136/archdischild-2015-310001. Epub 2016 May 25. Arch Dis Child. 2016. PMID: 27226526 Free PMC article.
How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement.
Severin T, Corriol-Rohou S, Bucci-Rechtweg C, An Haack K, Fuerst-Recktenwald S, Lepola P, Norjavaara E, Dehlinger-Kremer M; EFGCP Children’s Medicines Working Party; Haertter S, Cheung SYA; IQ Pediatric Working Group. Severin T, et al. Among authors: lepola p. Ther Innov Regul Sci. 2020 Sep;54(5):1076-1084. doi: 10.1007/s43441-020-00116-4. Epub 2020 Feb 6. Ther Innov Regul Sci. 2020. PMID: 32030690 Free PMC article.
26 results