Abstract
The Task-force in Europe for Drug Development for the Young (TEDDY) was established in 2005 to contribute to the promotion of safe and efficacious medicines for children in the context of the impending European Paediatric Regulation that finally came into force in January 2007. The project includes seven objectives and 12 Work-Packages encompassing the main aspects of the development and use of pediatric drugs. TEDDY represents a new entity in the pediatric pharmaceutical field, differing from a Scientific Society, a network for developing research or trials, or a consultative regulatory body. The ambition of TEDDY is to support the existing pediatric networks, societies, and regulatory bodies in performing innovative initiatives, including those in areas in which such undertakings would not be feasible without supportive action. To accomplish its aim, TEDDY has focused on three different actions: (i) increasing awareness about the Paediatric Regulation revolution; (ii) reaching consensus on terms and instruments to be used for common research; and (iii) favoring close relationships among different stakeholders and partners from different EU Member States. After 3 years of activities, many results have been produced by the Network: surveys, databases, expert opinions, and recommendations. Linking together different stakeholders, including industry and patient associations, as well as academia and research centers, the Network has contributed to increasing awareness and participation in the Paediatric Regulation. In addition, many papers detailing original results have either been published or submitted for publication in peer-reviewed journals.
TEDDY is an original Network whose identity and role as a catalyzer of initiatives related to the use and development of pediatric drugs needs to be better clarified in the near future. Of particular importance is the need to reach consensus on best practices. The lack of a common view on pediatric research requirements among stakeholders across Member States remains the main challenge to be overcome.
Similar content being viewed by others
References
European Commission. Sixth EU Framework Programme (FP6) [online]. Available from URL: http://ec.europa.eu/research/fp6/ [Accessed 2008 Dec 8]
European Commission. Work programme for the specific programme for research, technological development and demonstration: “integrating and strengthening the European research area”. PRIORITY 1: Life Sciences, Genomics and Biotechnology for Health, the Sixth Framework Programme [online]. Available from URL: http://cordis.europa.eu/fp6/ [Accessed 2008 Jul 9]
European Commission Enterprise Directorate General. Better medicines for children: proposed regulatory actions on paediatric medicinal products. Consultation document [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2002/feb/cd_pediatrics_en/pdf [Accessed 2008 Jul 9]
Regulation (EC) n. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. J Eur Union 2006; L378: 1–19
Regulation (EC) n. 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use. J Eur Union 2006; L378: 20–1
Krekels EH, van den Anker JN, Baiardi P, et al. Pharmacogenetics and paediatric drug development: issues and consequences to labelling and dosing recommendations. Expert Opin Pharmacother 2007 Aug; 8(12): 1787–99
Krekels E, Ceci A, Iolascon A, et al. The role of paediatric pharmacogenetic studies in Europe. Pharm Policy Law. In press
Grosch-Woerner I, Verhamme K, Kagedal B, et al. Recommendations on gender issues in clinical research management [online]. Available from URL: http://www.teddyoung.org [Accessed 2008 Jul 9]
Sen EF, Sturkenboom MCJM. The TEDDY Network: epidemiological trends in paediatric drug use in Europe. EJHP 2007 (6): 22–4
Ackers R, Murray ML, Besag FM, et al. Prioritizing children’s medicines for research: a pharmacoepidemiologic study of antiepileptic drugs. Br J Clin 2007 Jun; 63(6): 689–97
Medina Claros AF, Mellado Peña MJ, y Baquero Artigao F. Es Bases para el uso clínico de fármacos en niños: situación actual de uso de farmacos pediatricos en España. An Esp Ped Formación Continuada 2008; 6(3): 187–90
Neubert A, Sturkemboon MCJM, Murray ML, et al. Databases for paediatric medicines research in Europe: assessment and critical appraisal. Pharmacoepidemiol Drug Saf. Epub 2008 Oct 31
Sturkemboon MCJM, Verhamme KMC, Nicolosi A, et al. Drug use in children: cohort study in three European countries. BMJ 2008 Nov 24; 337: a2245
Sturkenboom M, Felisi M, Manfredi C, et al. Paediatric status and off-label use of drugs in children in Italy, United Kingdom and The Netherlands. Pharm Policy Law. In press
Sturkenboom M, Verhamme K, Murray M, et al. General drug utilization in children: a multinational database study in the TEDDY Project [poster]. 23rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management; 2007 Aug 19–22; Quebec City (QC)
Neubert A, Murray M, Sturkenboom M, et al. Population-based databases for paediatric medicine research in Europe: a TEDDY appraisal [poster]. 23rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management; 2007 Aug 19–22; Quebec City (QC)
Verhamme K, Picelli G, Giaquinto C, et al. Cardiovascular drug use in children: the Teddy Project [poster]. 23rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management; 2007 Aug 19–22; Quebec City (QC)
Murray M, Neubert A, Picelli G, et al. Drug utilisation of neuropsychiatric drugs in children: a multinational study within the TEDDY project [poster]. 23rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management; 2007 Aug 19–22; Quebec City (QC)
Sturkenboom M, Verhamme K, Murray M, et al. Respiratory drug use in children: a multinational database study in the TEDDY project [poster]. 23rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management; 2007 Aug 19–22; Quebec City (QC)
Neubert A, Murray M, Sturkenboom M, et al. Drug utilisation of analgesics and anti-inflammatory drugs in children: a multinational database study within the TEDDY project [poster]. 23rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management; 2007 Aug 19–22; Quebec City (QC)
Felisi M, Baiardi P, Verhamme K, et al. Paediatric status and off-label use of drugs in children [oral presentation]. 11th Biannual European Society for Developmental Parinatal and Paediatric Pharmacology Congress; 2008 Jun 4–7; Rotterdam
Sen EF, Verhamme K, Neubert A, et al. Respiratory drug use in children in the Netherlands, Italy and United Kingdom [oral presentation]. 11th Biannual European Society for Developmental Parinatal and Paediatric Pharmacology Congress; 2008 Jun 4–7; Rotterdam
Verhamme K, Elferink-Stinkens P, Murray M, et al. Adverse drug reaction reporting in children: the Teddy project [poster]. 23rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management; 2007 Aug 19–22; Quebec City (QC)
Neubert A, Bonifazi A, Catapano M, et al. Defining off-label and unlicensed use of medicines for children: results of a Delphi survey. Pharmacol Res. In press
Ceci A, Felisi M, Baiardi P, et al. Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years. Eur J Clin Pharmacol 2006; 62(11): 947–52
Task-force in Europe for Drug Development for the Young (TEDDY) [online]. Available from URL: http://www.teddyoung.org [Accessed 2008 Dec 8]
Paolucci P, Pritchard Jones K, del Carmen Cano Garcinuno M, et al. Challenges in prescribing drugs for children with cancer. Lancet Oncol 2008 Feb; 9(II): 176–83
European Clinical Trials Database (EudraCT) [online]. Available from URL: http://eudract.emea.europa.eu/ [Accessed 2008 Dec 8]
Community Database on Medicinal Products (EUDRAPharm) [online]. Available from URL: http://eudrapharm.eu/eudrapharm/welcome.do [Accessed 2008 Dec 15]
Altavilla A, Giaquinto C, Giocanti D, et al. Activity of ethics committees in Europe on issues related to clinical trials in paediatrics: results of a survey. Pharm Policy Law. In press
European Commission Enterprise Directorate General. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population: recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev10.htm [Accessed 2008 Nov 25]
Acknowledgements
This paper is part of the TEDDY Network of Excellence funded within the Sixth EC Framework Programme (Contract no. 0005216 LSHBCT- 2005-005126). Oscar Della Pasqua is the partner of the Network, Leader of Work-Package 2. Carlo Giaquinto has received consultancies from GlaxoSmithKline (GSK), Abbott, BMS, Tibotec, Gilead, Sanofi Pasteur MSD (SPMSD), and Boehringer Ingelheim (BI) and honoraria from GSK, Abbott, BI, Tibotec, and SPMSD. The other authors have no conflicts of interest that are directly relevant to the content of this paper.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Ceci, A., Giaquinto, C., Aboulker, JP. et al. The Task-force in Europe for Drug Development for the Young (TEDDY) Network of Excellence. Pediatr-Drugs 11, 18–21 (2009). https://doi.org/10.2165/0148581-200911010-00008
Published:
Issue Date:
DOI: https://doi.org/10.2165/0148581-200911010-00008