Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines

Author:

Ravinetto Raffaella,De Nys Katelijne,Boelaert Marleen,Diro Ermias,Meintjes Graeme,Adoke Yeka,Tagbor Harry,Casteels Minne

Publisher

Springer Science and Business Media LLC

Subject

Public Health, Environmental and Occupational Health

Reference27 articles.

1. Levinson DR. US Department of Health and Human Services, Office of Inspector General. Challenges to FDA’s ability to monitor and inspect foreign clinical trials, 2001. OEI-01-08-00510. Accessed 19th November 2014 from http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf

2. European Medicines Agency. Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU Regulatory Authorities, 2012. EMA/121340/2011. Accessed 19th November 2014 from http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125437.pdf

3. Burrows JN, Elliott RL, Kaneko T, Mowbray CE, Waterson D. The role of modern drug discovery in the fight against neglected and tropical diseases. Med Chem Commun. 2014;5:688–700.

4. G-Finder. Neglected diseases research and development: the public divide. Policy Cures 2013, Sydney, Australia. Accessed 19th November 2014 from http://www.policycures.org/downloads/GF_report13_all_web.pdf

5. Kilama WL, Chilengi R, Wanga CL. Towards an African-Driven Malaria Vaccine Development Program: History and Activities of the African Malaria Network Trust (AMANET). Am J Trop Med Hyg. 2007;77 Suppl 6:282–8.

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