References
- Based on the authors' presentation given at the 20th Symposium of Clinical Pharmacy in honour of late Assoc. Prof. PharmDr. Lívia Magulová, PhD., Nitra, Slovakia, April 28 - 29, 2011.
- 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:PDF
- ICH E11 Note for Guidance on the Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99). Available at: http://www.emea.europa.eu/pdfs/human/ich/271199EN.pdf
- ALRAVILLA, A. - MANFREDI, C. - BAIARDI, P. et al.: Impact of the new European paediatric regulatory framework on ethics committees: overview and perspectives. Acta Paediatr, 2012, 101, No. 1, p. e27-32. (Epub 2011 Jul 23).
- ICH E11, p. 5 - 6.
- ICH E11, p. 5 - 6.
- ICH E11, p. 6 - 7.
- ICH E11, p. 11 - 13.
- Ethical Considerations for Clinical Trials on Medicinal Products Conducted with 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. European Commission, 2008, 34 pgs. (further on "EC Recommendations 2008") Available at: http://ec.europa.eu/health/files/eudralex/vol-10/ethical_considerations_en.pdf
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
- EC Recommendations 2008, p. 13.
- EC Recommendations 2008, p. 13 - 14.
- Committee for Medicinal Products for Human Use (CHMP): Guideline on Conduct of Pharmacovigilance for Medicines Used by the Paediatric Population, EMEA, London, 25 January 2007. Doc. Ref. EMEA/CHMP/PhVWP/235910/2005- rev.1, p. 3 - 4. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003764.pdf
- We refer in this text to the provisions contained in the law No. 326/2011 Coll., which since December 2011 has superseded the original law No. 140/1998 Coll.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.sk