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Article type: Research Article
Authors: Ceci, A. | Baiardi, P. | Bonifazi, F. | Giaquinto, C. | Mellado Peña, M.J. | Mincarone, P. | Nicolosi, A. | Sturkenboom, M. | Wong, I.
Affiliations: Consorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy | I.RI.D.I.A. srl, Health Care Engineering, Bari, Italy | Department of Paediatrics, University of Padova, Padova, Italy | Department of Paediatrics, Hospital Carlos III, Madrid, Spain | Italian Embassy in Belgium, Brussels, Belgium | Pharmacoepidemiology Unit, Departments of Medical Informatics and Epidemiology & Biostatistics, Erasmus University Medical Center, Rotterdam, The Netherlands | Centre for Paediatric Pharmacy Research, The School of Pharmacy and Institute, Contro Nazionale delle Ricerche-Tecnologie Biomediche, Milan, Italy
Note: [] Corresponding author: Adriana Ceci, Consorzio per Valutazioni Biologiche e Farmacologiche, Via Palestro, 26 – 27100 Pavia, Italy. Tel.: +39 0382 25075; Fax: +39 0382 536544; E-mail: aceci@cvbf.net
Abstract: The lack of good quality medicines with formulations tailored for children and supported by properly conducted clinical trials or high level clinical evidence is a longstanding problem in Europe and worldwide. The adoption of the new Paediatric Regulation (Reg. 1901/2006/EC), which forces pharmaceutical industries to conduct a paediatric investigation plan (PIP), is expected to increase the availability of properly tested and authorised medicines for paediatric use. In this framework, the Task-force in Europe for Drug Development for the Young (TEDDY) Network of Excellence was established in 2005 to promote cooperation among researchers and other important stakeholders (regulatory authorities, professionals, patients and consumers) in order to optimise the paediatric use of current drugs and promote the development of new drugs for children, thus actively supporting the implementation of the European Paediatric Regulation.
Keywords: TEDDY, paediatric medicine, FP6 project, Network of Excellence, Paediatric Regulation, Europe
DOI: 10.3233/PPL-2009-0206
Journal: Pharmaceuticals, Policy and Law, vol. 11, no. 1-2, pp. 13-21, 2009
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