Ethical issues in clinical trials in children

Based on the authors' presentation given at the 20^th Symposium of Clinical Pharmacy in honour of late Assoc. Prof. PharmDr. Lívia Magulová, PhD., Nitra, Slovakia, April 28 - 29, 2011.Search in Google Scholar

Regulation (EC) No 1901/2006 of the European Parliament and the Council, as amended, on medicinal products for paediatric use (‘Paediatric Regulation’). Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:378:0001:0019:EN:PDFSearch in Google Scholar

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ICH E11, p. 5 - 6.Search in Google Scholar

ICH E11, p. 5 - 6.Search in Google Scholar

ICH E11, p. 6 - 7.Search in Google Scholar

ICH E11, p. 11 - 13.Search in Google Scholar

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We refer in this text to the provisions contained in the law No. 326/2011 Coll., which since December 2011 has superseded the original law No. 140/1998 Coll. on medicinal drugs and medical devices. The later version of the medicinal drugs and devices law was valid at the time of delivery of the original authors' presentation (see ref. 1). The text of the law available in Slovak language at: http://www.zbierka.skSearch in Google Scholar