Back New Guide to the quality and safety of tissues and cells for human application

EDQM Strasbourg, France 20/09/2019
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The EDQM has just released the new edition of its Guide to the quality and safety of tissues and cells for human application. This 4th edition provides healthcare professionals with an extensive overview of the most recent advances in the field, as well as technical guidance to ensure the quality and safety of human tissues and cells for human application.

The Guide provides support to professionals on a practical level with the type of guidance that aims at ensuring the successful clinical application of tissues and cells. It also lays out the ethical principles and guidelines that must be taken into consideration in the context of tissue and cell donation and related human applications.

The guide contains specific information and guidance for:

  • professionals involved in identifying potential donors;
  • transplant co-ordinators managing the process of donation after death;
  • bone marrow and cord blood collection centres;
  • fertility clinics;
  • tissue establishments processing and storing tissues and cells;
  • testing laboratories;
  • organisations responsible for human application;
  • inspectors auditing the establishments;
  • health authorities responsible for tissues and cells for human application.

This project is co-financed by the Council of Europe and the European Union. It benefits from the contribution of internationally recognised experts and several scientific and professional organisations, including the European Association of Tissue and Cell Banks (EATCB), the European Eye Bank Association (EEBA), the European Society for Human Reproduction and Embryology (ESHRE), the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee ISCT-Europe and EBMT (JACIE). The guide constitutes a common European standard based on the long-standing expertise and knowledge of the EDQM, Council of Europe.