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This report was prepared by the conference rapporteurs: Professor Hannsjörg W. Seyberth, past president of the European Society for Developmental Perinatal and Paediatric Pharmacology and European Network for Drug Investigation in Children (ESDP-ENDIC), chairman of the Committee on Drug Safety, German Paediatric Society (DGKJ) and chairman of the Department of Paediatrics, Philipps University, Marburg, Germany; Professor Jacques Demotes-Mainard, coordinator of the European Clinical Research Infrastructures Network (ECRIN) and Institut National de la Santé et de la Recherche Médicale (INSERM), France, with the support of Mr. Peter Wrobel, EFGCP commissioned writer, European Forum for Good Clinical Practice, 2005. All rights in this document are reserved by the EFGCP, a not-for-profit organisation chartered under Belgian law. The EFGCP hereby gives permission for this document to be freely reviewed, abstracted, reproduced or translated, provided it receives a copy of such. This document may not be sold in conjunction with commercial purposes without the express written permission of the EFGCP.
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Seyberth, H.W., Demotes-Mainard, J. & Wrobel, P. Developing a European framework for research on children’s medicines: an examination of the proposed EU regulation on medicinal products for paediatric use. Pediatr Nephrol 20, 1537–1540 (2005). https://doi.org/10.1007/s00467-005-2103-6
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DOI: https://doi.org/10.1007/s00467-005-2103-6