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Sécurité et assurance qualité dans le don, la récolte et la conservation de cellules et tissus d'origine humaine : une synthèse de notre propre expérience.

Safety and quality assurance in donation, harvest and preservation of cells and tissues of human origin: a review of own experience.

Numéro : pap. n. 070

Auteurs : MERICKA P., STRAKOVÁ H., STERBA L.

Résumé

The authors review their own experience with implementation of the quality and safety assurance system in donation, harvest, further processing and distribution of cells and tissues of human origin intended for clinical application in man defined in the European Union by Directives 2004/23/EC, 2006/17/EC and 2006/86/EC. The issue of safety and quality has been systematically monitored and analyzed by authors with the aim to achieve compliance with the directives. In the year 2004 the Tissue Bank was granted the temporary licence by the Ministry of Health that covered both minimally manipulated cell and tissue grafts and cells expanded in vitro. As the new harmonized national legal norms came into force in 2008 the Tissue Bank was obliged to apply for a new licence at the State Institute for Drug Control. This licence was granted after 2.5 year lasting process and covered exclusively minimally manipulated grafts. In vitro expanded cells that are now classified as advanced medicinal products were a subject of separate licensing process that was successfully completed in 2011.

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Format PDF

Pages : 260-265

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    20 €

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Détails

  • Titre original : Safety and quality assurance in donation, harvest and preservation of cells and tissues of human origin: a review of own experience.
  • Identifiant de la fiche : 30006659
  • Langues : Anglais
  • Source : Cryogenics 2012. Proceedings of the 12th IIR International Conference: Dresden, Germany, September 11-14, 2012.
  • Date d'édition : 11/09/2012

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