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01-07-2008 | Correspondence

EU initiatives for research involving children

Author: Fergal Donnelly

Published in: European Journal of Pediatrics | Issue 7/2008

Abstract

Further to recent correspondence in the medical press regarding the UK approach (Editorial in Lancet 367:1953, 2006; Smyth and Edwards in Lancet 368:645–646, 2006) to the Paediatric Medicines Regulation (Regulation (EC) no. 1901/2006, 2006), which has now entered into force, we would like to make reference to a number of research-based initiatives of the European Union in this field.

Call for Proposals under the Cooperation and Capacities Work Programmes of the 7th EC Framework Programme for Research, Technological Development and Demonstration Activities. Official Journal of the European Union C 135/5, 19 June 2007. Available online at: http://cordis.europa.eu/fp7/dc/index.cfm?fuseaction=UserSite.CooperationDetailsCallPage&call_id=63

Ceci A, Felisi M, Baiardi P, Bonifazi F, Catapano M, Giaquinto C, Nicolosi A, Sturkenboom M, Neubert A, Wong I (2006) Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years. Eur J Clin Pharmacol 62:947–952PubMedCrossRef

Chalumeau M, Tréluyer JM, Salanave B, Assathiany R, Chéron G, Crocheton N, Rougeron C, Mares M, Bréart G, Pons G (2000) Off label and unlicensed drug use among French office based paediatricians. Arch Dis Child 83:502–505PubMedCrossRef

Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli MP, Rocchi F, Bonati M, ‘t Jong G, de Hoog M, van den Anker J (2000) Survey of unlicensed and off label drug use in paediatric wards in European countries. Br Med J 320:79–82CrossRef

Decision no. 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (2007–2013). Official Journal of the European Union, L 412/1, 30 December 2006

Editorial (2006) Clinical trials in children, for children. Lancet 367:1953CrossRef

Proposal for a regulation of the European Parliament and of the Council laying down the rules for the participation of undertakings, research centres and universities in actions under the Seventh Framework Programme and for the dissemination of research results (2007–2013), Brussels, 23 December 2005, COM(2005) 705 final, 2005/0277 (COD). Available online at: http://cordis.europa.eu/fp7/who_en.html#provisions

Regulation (EC) no. 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 (text with EEA relevance). Official Journal of the European Union L 378/1, 27 December 2006

Smyth RL, Edwards AD (2006) Medicines for children. Lancet 368:645–646PubMedCrossRef

10.

Task-force in Europe for Drug Development for the Young (TEDDY).Home page at: http://www.teddynoe.org/project/

11.

Updated Priority List—Revised for Studies into Off-Patent Paediatric Medicinal Products. Document ref. EMEA/197972/2007, London, June 2007. Available online at: http://www.emea.europa.eu/pdfs/human/paediatrics/19797207en.pdf

Title: EU initiatives for research involving children
Author: Fergal Donnelly
Publication date: 01-07-2008
Publisher: Springer-Verlag
Published in: European Journal of Pediatrics / Issue 7/2008
Print ISSN: 0340-6199
Electronic ISSN: 1432-1076
DOI: https://doi.org/10.1007/s00431-008-0671-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

EU initiatives for research involving children

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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