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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

CliniGene publication related to regulation & ethics

CliniGene recent publications

En route to ethical recommendations for gene transfer clinical trials.

King NM, Cohen-Haguenauer O.

Mol Ther. 2008 Mar;16(3):432-8.

PMID: 18297094

 

Eurogenethy publications

Opinion Paper on the current Status of the Regulation of Gene Therapy in Europe

Odile Cohen-Haguenauer, Felicia Rosenthal, Bernd Gansbacher, Reinder Bolhuis, Karoline Dorsch-Häsler, Gösta Gahrton, Peter Hokland, Cecilia Melani, Elaine Rankin, Kris Thielemans, Richard Vile, Heinz Zwierzina, and Klaus Cichutek, for the Euregenethy Network

Human Gene Therapy – Nov 20, 2002

Highlights of the Second Euregenethy Multidisciplinary Forum on Regulatory Issues in Gene Therapy

Odile Cohen-Haguenauer

John Wiley & Sons, Ltd.

Journal of Gene Medicine Supplement to Vol 2 N°4, 2000

EUREGENETHY : Regulation of Gene Therapy in Europe – a scientific network of users

The Euregenethy Network

Euregenethy Newsletter N°1 – June 1999

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