Clinical Trials Directive (Draft)
Bulletin of Medical Ethics 2000 July-August; (160): 19-24
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Transposition De La Directive Essais Cliniques: Recommandations Sur Le Contenu d'un Dossier De Demande d'autorisation Pour Les Premiers Essais Chez l'homme = Adaptation of the Clinical Trials Directive: Recommendations on the Contents of A Dossier for the Request for Authorisation of the First Trials in Human Subjects Bélorgey, Chantan; Plétan, Yannick; Goehrs, Jean-Marie (2004-05)
Draft Commission Directive Laying Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as Well as the Requirements for Authorisation of Manufacturing or Importation Of Such Products Unknown author (European Commission, 2004-06-14)This proposed directive redrafts the original European Union clinical trials directive (2001/20/EC) that was developed to govern approval and monitoring of commercially-sponsored clinical research in countries of the ...
Safeguarding Clinical Trials. Efforts Are Underway to Modernize Clinical Trial Standards and Normalize Regulations to Facilitate International Collaboration. but as the European Union's Clinical Trials Directive Shows, a One-Size-Fits-All Regulatory Strategy May Be Easier to Conceive Than to Implement Unknown author (2007-02)