Clinical Trial Application in Europe: What Will Change with the New Regulation?-Reference-Cited by-同舟云学术

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Clinical Trial Application in Europe: What Will Change with the New Regulation?

Published:2015-06-03 Issue:2 Volume:22 Page:451-466
ISSN:1353-3452
Container-title:Science and Engineering Ethics
language:en
Short-container-title:Sci Eng Ethics

Author:

Giannuzzi Viviana,Altavilla Annagrazia,Ruggieri Lucia,Ceci Adriana

Publisher

Springer Science and Business Media LLC

Subject

Management of Technology and Innovation,Health Policy,Issues, ethics and legal aspects,Health(social science)

Link

http://link.springer.com/content/pdf/10.1007/s11948-015-9662-0.pdf

Reference31 articles.

1. Altavilla, A., Giaquinto, C., & Ceci, A. (2008). European survey on ethical and legal framework of clinical trials in paediatrics: Results and perspectives. Journal International de Bioéthique, 19(3), 17–48.

2. Altavilla, A., Giaquinto, C., Giocanti, D., et al. (2009). Activity of ethics committees in Europe on issues related to clinical trials in paediatrics: Results of a survey. Pharmaceuticals Policy and Law, 11(1,2), 79–87.

3. Altavilla, A., Manfredi, C., Baiardi, P., et al. (2012). Impact of the new European paediatric regulatory framework on ethics committees: Overview and perspectives. Acta Paediatrica, 101(1), 27–32.

4. Atzor, S. (2013). Will the EU clinical trials regulation support the innovative industry in bringing new medicenes faster to patients. Pharmaceutical Medicine, 27, 75–82.

5. Bilbault, P., Belorgey, C., Zannad, F., Golinelli, D., Pletan, Y., & participants of Round Table n°4 of Giens XXV. (2010). Clinical trials legislation—Preparing for the revision of the European Directive Scheduled for 2011. Therapie, 65(4), 301–308.

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