Share

IIR document

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

Number: pap. n. 070

Author(s) : MERICKA P., STRAKOVÁ H., STERBA L.

Summary

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.

Available documents

Format PDF

Pages: 260-265

Available

  • Public price

    20 €

  • Member price*

    Free

* Best rate depending on membership category (see the detailed benefits of individual and corporate memberships).

Details

  • Original title: Safety and quality assurance in donation, harvest and preservation of cells and tissues of human origin: a review of own experience.
  • Record ID : 30006659
  • Languages: English
  • Source: Cryogenics 2012. Proceedings of the 12th IIR International Conference: Dresden, Germany, September 11-14, 2012.
  • Publication date: 2012/09/11

Links


See other articles from the proceedings (78)
See the conference proceedings

Indexing