Accès gratuit
Volume 62, Numéro 3, Mai-Juin 2007
XXIIes Rencontres Nationales de Pharmacologie Clinique, Giens 7-10 octobre 2006
Page(s) 223 - 227
Section Étude clinique/Clinical Study
Publié en ligne 15 septembre 2007
  1. ICH International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use Mai 1996.
  2. European Parliament and Council Directive 2001/20/EC on the approximation of the European Union the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice on medicinal products for human use 2001.
  3. Avis n°41 (1993) et n°78 (2003) du Comité Consultatif National d'Ethique pour les sciences du vivant CCNE.
  4. Charte éthique de l'ANRS 1999.
  5. Royaume-Uni, avis from Nuffield Council on Bioethics: “The ethics of research related to healthcare in developing countries” 2005.
  6. USA, Report and recommendations of the National Bioethics Advisory Commission. Ethical and policy issues in international research: clinical trials in developing countries 2001.
  7. Déclaration d'Helsinki (Edinburgh) 2000, Association Médicale Mondiale.
  8. IOMS/WHO International ethical guidelines for biomedical research involving human subjects 1993, revise en 2001.
  9. UNESCO Déclaration universelle sur la bioéthique et les droits de l'homme 2005.
  10. Council of Europe Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine, Oviedo 1997.