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Clinical Trials in Developing Countries

This project is related to a tender of DG External Policies of the European Union, assigned to SOMO. The main objective was to provide the European Parliament with a research paper containing concrete recommendations, both at legislative and enforcement level, aimed to guarantee that trials performed in third countries are conducted in conformity with EU and international ethical standards.

Results:

The publication and presentation of the research paper to the Commission of DG Development (March 2009). The research paper has served as a source of reference for the public consultation paper for the assessment of the functioning of the "Clinical Trials Directive 2001/20/EC” which was published in October 2009. The paper was also subject in parliamentary questions submitted by Thijs Berman (S&D) and Judith A. Merkies (S&D) to the Council on 30 November 2009.

Start Date 2007/01/01
End Date 2010/12/31
Commissioned by DG External Policies of the European Union
Dossiers Pharmaceutical Industry

 

  

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