Challenges in Paediatric Clinical Trials: How to Make It Feasible

Author:

Chiaruttini Giulia,Felisi Mariagrazia,Bonifazi Donato

Publisher

InTech

Reference30 articles.

1. ICH. E11—Clinical Investigation of Medicinal Products in the Paediatric Population. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/Step4/E11_Guideline.pdf [Accessed 19 July 2010]

2. EudraLex. Ethical Considerations for Clinical Trials on Medicinal Products Conducted with Minors, Revision 1. Available at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2017_09_18_ethical_consid_ct_with_minors.pdf [Accessed 17 September 2017]

3. European Parliament and Council. Regulation (EC) No 1901/2006 of the European Parliament and of the Council. Available at: https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf [Accessed 12 December 2006]

4. EMA. 10-year Report to the European Commission—General Report on the Experience Acquired as a Result of the Application of the Paediatric Regulation. Available at: https://ec.europa.eu/health/sites/health/files/files/paediatrics/2016_pc_report_2017/ema_10_year_report_for_consultation.pdf [Accessed 26 October 2016]

5. 108th US Congress. Pediatric Research Equity Act of 2003. Available at: https://www.congress.gov/108/plaws/publ155/PLAW-108publ155.pdf [Accessed 3 December 2003]

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