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: [email protected]
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
