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Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia.
Terzić V, Levoyer L, Figarella M, Bigagli E, Mercier N, De Gastines L, Gibowski S, Trøseid M, Demotes J, Olsen IC, Hites M, Ader F, Lopez JRA, Mentré F, Espérou H, Costagliola D, Røttingen JA, Poissy J, Rozé JC, Warris A, O'Leary J, Fernandes RM, Assoumou L, Hankard R, Turner MA, Yazdanpanah Y, Diallo A; EU-Response safety group; c4c safety group. Terzić V, et al. Among authors: turner ma. Br J Clin Pharmacol. 2023 Apr;89(4):1318-1328. doi: 10.1111/bcp.15669. Epub 2023 Feb 8. Br J Clin Pharmacol. 2023. PMID: 36680782 Free article. Review.
Development and performance of the c4c national clinical trial networks for optimizing pediatric trial facilitation.
Degraeuwe E, van der Geest T, Persijn L, Nuytinck L, Raes A, Turner M, Fernandes RM, Vande Walle J, de Wildt SN; IMI2 project conect4children (c4c) consortium, including National Hubs/Networks Belgian Pediatric Clinical Research Network (BPCRN) (Belgium) and Pedmed-NL (Netherlands). Degraeuwe E, et al. Front Pediatr. 2023 Dec 21;11:1302272. doi: 10.3389/fped.2023.1302272. eCollection 2023. Front Pediatr. 2023. PMID: 38188909 Free PMC article.
The development of the Belgian paediatric clinical trial network.
Degraeuwe E, Persijn L, Nuytinck L, Allegaert K, De Taeye L, Gasthuys E, Christiaens D, Karamaria S, Raes A, Turner M, Vande Walle J. Degraeuwe E, et al. Acta Clin Belg. 2024 Feb;79(1):34-45. doi: 10.1080/17843286.2023.2283664. Epub 2024 Jan 2. Acta Clin Belg. 2024. PMID: 38054741
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. Among authors: turner ma. 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.
European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children.
Guerlich K, Patro-Golab B, Barnacle A, Baumann U, Eicken A, Fraser AG, Gruszfeld D, Haas NA, Jonker AH, Kammermeier M, Kenny D, Kolaček S, Lapatto R, Maconochie I, Mader S, McGauran G, Melvin T, Muensterer O, Piscoi P, Romano A, Saxena AK, Schneider DT, Turner MA, Walle JV, Koletzko B; European Academy of Paediatrics. Guerlich K, et al. Among authors: turner ma. Acta Paediatr. 2023 Nov;112(11):2440-2448. doi: 10.1111/apa.16919. Epub 2023 Aug 15. Acta Paediatr. 2023. PMID: 37485905
Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines.
Ruggieri L, Giannuzzi V, Baiardi P, Bonifazi F, Davies EH, Giaquinto C, Bonifazi D, Felisi M, Chiron C, Pressler R, Rabe H, Whitaker MJ, Neubert A, Jacqz-Aigrain E, Eichler I, Turner MA, Ceci A; GRiP Consortium. Ruggieri L, et al. Among authors: turner ma. Eur J Pediatr. 2015 Apr;174(4):481-91. doi: 10.1007/s00431-014-2398-z. Epub 2014 Sep 23. Eur J Pediatr. 2015. PMID: 25241827 Free PMC article.
481 results