What is the role of ethics committees after Regulation (EU) 536/2014?

Author:

Petrini Carlo

Publisher

BMJ

Subject

Health Policy,Arts and Humanities (miscellaneous),Issues, ethics and legal aspects,Health (social science)

Reference9 articles.

1. 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;European Parliament and Council of the European Union;Offic J Eur Union,2001

2. Clinical research in Europe – trials and tribulations;Lancet,2012

3. Re-engineering the European Union Clinical Trials Directive;Kenter;Lancet,2012

4. Cancer Research UK, Academy of Medical Sciences, Association of Medical Research Charities et al. Revision of the EU Clinical Trials Directive. A joint statement from non-commercial research organisations in the UK. 2011. http://www.acmedsci.ac.uk/download.php?file=/images/project/Jointsta.pdf (accessed 14 Jul 2015).

5. European Parliament, Council of the European Union. Proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. COM/2012/0369 final – 2012/0192. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0369:FIN:EN:PDF (accessed 14 Jul 2015).

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