European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice



    Description

Name

 

SwedPedMed - Swedich Pediatric Medicines

Number of peer reviewed publications in the last 5 years 5 Clinical impact of circulating biomarkers in prediction of adverse cardiac events in patients with congenital heart disease. A systematic review W.J. van Genuchten, H. Averesch, Q.M. van Dieren, D. Bonnet, M. Odemarsky, M. Beghetti, J.W. Roos-Hesselink, Z. Reinhardt, C. Male, E. Naumburg, E. Boersma, D. De Wolf, W.A. Helbing, also on behalf of Cardiology Expert Group of the connect4children (c4c) network. International Journal of Cardiology, Volume 0, Issue 0, 132723 Clinical, methodology, and patient/carer expert advice in pediatric drug development by conect4children.Cheng K, Mahler F, Lutsar I, Nafria Escalera B, Breitenstein S, Vassal G, Claverol J, Noel Palacio N, Portman R, Pope G, Bakker M, van der Geest T, Turner MA, de Wildt SN; c4c Expert Group Leads. Clin Transl Sci. 2022 Dec 12. doi: 10.1111/cts.13459. Epub ahead of print. PMID: 36510699 Evidence of support used for drug treatments in pediatric cardiology. Back, J, Wåhlander, H, Hanseus, K, Bergman, G, Naumburg, E. Health Sci Rep. 2021; 4:e288. https://doi.org/10.1002/hsr2.288 Improved infrastructure and support needed for paediatric clinical trials in Sweden. Acta Paediatr. 2020. Mar 14. Mattsson H, Kindblom JM, Norman E, Rane A, Naumburg E. Paediatric clinical trials need paediatric clinical trial budgets Stavros Koulizakos, Tina Kjellén, Karin Mellgren, Jenny M. Kindblom https://doi.org/10.1111/apa.16808
Number of competitive grants obtained in the last 5 years C4C, SwedPedMed
Access to expert groups Yes Via C4C and University hospitals in Sweden
Capacity to answer external scientific questions Yes Via C4C and University hospitals in Sweden
Site feasibility Yes
Participant recruitment Yes
Budget calculation for studies Yes