Guide to the Quality and Safety of Tissues and Cells for Human Application
Author: European Directorate for the Quality of Medicines
Publisher:
Published: 2019
Total Pages: 666
ISBN-13: 9789287189455
DOWNLOAD EBOOK →Author: European Directorate for the Quality of Medicines
Publisher:
Published: 2019
Total Pages: 666
ISBN-13: 9789287189455
DOWNLOAD EBOOK →Author: Council of Europe Publishing
Publisher: Council of Europe
Published: 2004-01-01
Total Pages: 96
ISBN-13: 9287155186
DOWNLOAD EBOOK →This is the second edition of this publication which contains guidance on the transplantation of organs, tissues and cells of human origin for therapeutic purposes. It sets out safety and quality assurance standards for the procurement, preservation, processing and distribution of human organs, tissues and cells, in order to promote ethical concerns which recognise the safety and dignity of the donor and the recipient. The guide also contains the additional protocol to the Convention on Human Rights and Biomedicine on the transplantation of organs and human tissues.
Author: EDQM,
Publisher: Conseil de l'Europe
Published: 2013-01-01
Total Pages: 363
ISBN-13: 9789287176387
DOWNLOAD EBOOK →This 5th Edition of the Guide to the quality and safety of organs for transplantation collates updated information to provide professionals identifying organ donors, transplant co-ordinators managing the donation process and transplant physicians responsible for organ allocation and utilisation with a useful overview of the most recent advancements in the field. This guide is intended to provide easy-to-use information and guidance to all professionals involved in donation and transplantation of organs so as to maximise their quality and to minimise risks and, thereby, improve the success rate of transplants. The guide applies to the donation and transplantation of organs of human origin for therapeutic purposes. It covers important ethical principles that must always be respected in any donation and transplantation procedure, guidance on the assessment of donors to prevent the transmission of infectious, malignant or other diseases, recent views on donor management, as well as state-of-the-art information to ensure the quality and safety of organs during the multiple relevant procedures that take place from donation to transplantation. The guide makes reference to EU mandatory requirements where appropriate and describes generally-accepted good practice. New information relating to quality and safety standards for tissues and cells for human application are now separately published in the Guide to the quality and safety of tissues and cells for human application
Author: Council of Europe Publishing
Publisher: Council of Europe
Published: 2009-01-01
Total Pages: 184
ISBN-13: 9789287165688
DOWNLOAD EBOOK →Organ transplantation saves thousands of lives each day but raises some questions of principle. This guide, which is published on a biennial basis, provides guidance for all those involved in transplantation and other clinical applications of organs, tissues and cells, with the aim of optimising quality and reducing risks. The topics covered are: quality management, principles for ensuring the quality of organs, tissues and cells; selection of donors; organ procurement and preservation; tissue and cell procurement; tissue establishment; transplantation practices.
Author: Council of Europe Publishing
Publisher:
Published: 2002
Total Pages: 92
ISBN-13: 9789287148919
DOWNLOAD EBOOK →Author: Great Britain
Publisher:
Published: 2007-05-31
Total Pages: 24
ISBN-13: 9780110771526
DOWNLOAD EBOOK →Enabling power: European Communities Act 1972, s. 2 (2). Issued: 31.05.2007. Made: 24.05.2007. Laid: -. Coming into force: 25.05.2007 for the purposes of art. 1 (3); 05.07.2007 for all other purposes. Effect: 2004 c. 30 amended. Territorial extent & classification: E/W/S/NI (except part 6 which doesn't extend to Scotland). General. Supersedes draft SI issued 25.04.2007 (ISBN 9780110768342). EC note: These Regulations implement in part Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, as well as Commission Directives 2006/17/EC and 2006/86/EC laying down technical requirements in relation to Directive 2004/23/EC. These Regulations impose safety and quality requirements in relation to human tissue and cells intended for human application, including stem cells and cell lines grown outside the body; they do not apply to reproductive cells, embryos outside the human body, organs and blood
Author: European Directorate for the Quality of Medicines & Healthcare
Publisher:
Published: 2016-09-07
Total Pages: 356
ISBN-13: 9789287182876
DOWNLOAD EBOOK →Transplant medicine and transplantation have progressed during the last decades in a way that nobody would have imagined before. The transplantation of organs offers major therapeutic benefits and improvements to quality of life and is, in many cases, the only life-saving treatment for end-stage organ failure. This new 6th Edition of the Guide collates updated information to provide professionals identifying organ donors, transplant co-ordinators managing the donation process and transplant physicians responsible for organ allocation and utilisation with a useful overview of the most recent advancements in the field. It is intended to provide easy-to-use information and guidance to all professionals involved in donation and transplantation of organs so as to maximise their quality and to minimise risks and, thereby, improve the success rate of transplants. The transplantation of organs offers major therapeutic benefits and improvements to quality of life and is, in many cases, the only life-saving treatment for end-stage organ failure. The most critical factor remains the supply of organs for transplantation, but only organs recovered following strict quality and safety standards are likely to function satisfactorily, and careful evaluation of donors is essential to minimise the risk of transmission of infections or malignancies. Furthermore, since human organs can currently only be derived from the body of a person, strong ethical principles need to be associated with their use. The Council of Europe approaches organ transplantation in compliance with the principles of non-commercialisation and voluntary donation of materials of human origin. This 6th Edition of the Guide to the quality and safety of organs for transplantation contains updated information on organ donation and transplantation to provide professionals identifying organ donors, transplant co-ordinators, managing the donation process and transplant physicians responsible for organ allocation and utilisation with a useful overview of the most recent advancements in the field. This will help them on a practical level by providing easy-to-use information at the bedside.
Author: European Directorate for the Quality of Medicines & Healthcare
Publisher:
Published: 2013-10-11
Total Pages: 320
ISBN-13: 9789287176394
DOWNLOAD EBOOK →This guide provides state-of-the-art information in order to maximise the quality and minimise the risks during donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. As with all transplanted material of human origin, tissues and cells carry risks of disease transmission, which must be controlled by the application of scrupulous donor selection criteria (including testing) and comprehensive quality systems. The idea behind this guide is to help professionals on a practical level by providing generic guidance that will help improve the rate of successful clinical application of tissues and cells. The guide makes reference to EU mandatory requirements where appropriate and describes generally-accepted good practice. It has been divided into two parts. Part A contains general requirements applicable to all establishments involved in the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. Part B contains specific guidelines and requirements for the different tissue and/or cell types