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CliniGene - NoE

European Network for the advancement of Clinical Gene Transfer & Therapy : EC-NoE fostering interaction of all stakeholders in the field in order to facilitate and help harmonise Ethical, Quality, Efficacy and Regulatory Issues.

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Regulation & Ethics Topics

  • CliniGene comments on EU Guidelines
  • CliniGene publication related to regulation & ethics
  • National (member states, Israel & Switzerland)
  • US regulation
  • NIH guidance on informed consent for gene transfer research
  • EU reference texts in the area of ethics in research
  • International regulation
  • European Medicines Agency
  • CAT meetings
  • CAT Working Party

US regulation

  • U.S. Food and Drug Administration - Center for Biologics Evaluations and Research Web Site. FDA-CBER
    References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies (OCTGT)

  • National Institutes of Health - Office of Biotechnology Activities (OBA).
    Information regarding referrals and information on specific gene trials are available here.

  • GeMCRIS - Genetic Modification Clinical Research Information System
      
  • National Institutes of Health - National Bioethics Advisory Committee (NBAC)
     
  • U.S. Department of Health and Human Services : Office for Human Research protections (OHRP)

 

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    • Sixth Framework programme
      EC-09 research
      L5HB-CT-2006-010933