Application challenges of the new EU Clinical Trials Regulation

Author:

Gefenas Eugenijus,Cekanauskaite Asta,Lekstutiene Jurate,Lukaseviciene Vilma

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference20 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. Official J Eur Commun L121:34–44

2. No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official J Eur Commun L158:1–76

3. Gøtzsche P (2012) Deficiencies in proposed new EU regulation of clinical trials. BMJ. doi: 10.1136/bmj.e8522

4. European Commission (2012) 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. http://ec.europa.eu/health/files/clinicaltrials/2012_07/proposal/2012_07_proposal_en.pdf . Accessed 9 May 2017

5. NHS European Office (2014) The new EU Clinical Trials Regulation: how NHS research and patients will benefit. http://www.nhsconfed.org/resources/2014/09/the-new-eu-clinical-trials-regulation-how-nhs-research-and-patients-will-benefit . Accessed 9 May 2017

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