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Author: European Directorate for the Quality of Medicines
Publisher:
ISBN: 9789287189455
Category :
Languages : en
Pages : 666
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Book Description
Author: European Directorate for the Quality of Medicines
Publisher:
ISBN: 9789287189455
Category :
Languages : en
Pages : 666
Get Book Here
Book Description
Author: European Directorate for the Quality of Medicines & Healthcare
Publisher:
ISBN: 9789287176394
Category : Cell transplantation
Languages : en
Pages : 320
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Book Description
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
Author: Mahmoud Aljurf
Publisher: Springer Nature
ISBN: 3030644928
Category : Medical
Languages : en
Pages : 181
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Book Description
This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.
Author:
Publisher:
ISBN: 9789287185969
Category :
Languages : en
Pages : 507
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Book Description
Author: George Galea
Publisher: Springer Nature
ISBN: 303071621X
Category : Medical
Languages : en
Pages : 288
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Book Description
It has been 10 years since the first edition of ‘Essentials of Tissue Banking’ has been published. There is still relatively little published on the technical and scientific principles on routine tissue and cell banking based on scientific principles. The 1st edition was very successful and, after a 10 year gap, there is a need of an update and an expansion of the book’s remit. The format of the book follows that of the previous edition- split into 5 sections. Management of donors and the banking of common tissues and cells; Principles of storage and processing of tissues and cells; Ensuring the safety of the products by testing the donor, the tissues and the environment, supported by a quality system and an IT infrastructure- all working within the constraints of current regulatory and ethical environments. This edition however provides a significant update. Many the chapters have been completely rewritten by different experts. Like the 1st edition, they were given a free hand in the way they wrote their chapter, with a guideline that they had to be concise, clear and up to date. The authors were also asked to provide the scientific and technical basis that provides the rationale of the processes they describe. Also, the scope of the book has been somewhat extended. In view of the fact that many cellular therapies are now routinely practiced, 2 new chapters have been added: one on the banking of haematopoietic stem cells and one on human embryonic stem cells. They have been deliberately chosen to illustrate the extreme spectrum of cellular therapies from one of the simplest to one of the most complex. The intention of the book has remained the same: to cover and update banking of current practices in essential tissue and cell banking. It is therefore hoped that by keeping the book as concise and up to date as possible, it will find a place on the shelves of many tissue establishments.
Author: Council of Europe
Publisher: Council of Europe
ISBN:
Category : Political Science
Languages : en
Pages : 28
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Book Description
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964). The 37 member states and European Union (EU) that have signed the Convention are committed to achieving harmonisation of the quality of medicines throughout the European continent and beyond. This brochure presents the activities of the EDQM.
Author: David Mortimer
Publisher: Cambridge University Press
ISBN: 1009181637
Category : Health & Fitness
Languages : en
Pages : 381
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Book Description
Preceded by A practical guide to basic labratory andrology / Lars Bjèorndahl... [et al.]. 2010.
Author: David K. Gardner
Publisher: CRC Press
ISBN: 1498740111
Category : Medical
Languages : en
Pages : 2002
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Book Description
Already established as a classic comprehensive reference for the whole team at the IVF clinic, this new edition has been extensively revised, with the addition of several important new contributions on laboratory ( including advanced sperm selection techniques for ICSI, human embryo biopsy procedures, oocyte activation, managing an oocyte bank, artificial gametes, and epigenetics) as well as on clinical topics (including GnRH agonist triggering, segmentation of IVF treatment, uterus transplantation, and risk and safety management). As previously, methods, protocols, and techniques of choice are presented by eminent contributors internationally.
Author: Council of Europe
Publisher: Manhattan Publishing Company
ISBN:
Category : Medical
Languages : en
Pages : 184
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Book Description
Author: Nils Hoppe
Publisher: Universitätsverlag Göttingen
ISBN: 3863950313
Category : Medical
Languages : en
Pages : 183
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Book Description
"Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was one of the aims of the EU-funded Tiss.EU project ('Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union--an Evidence-Based Impact Analysis') to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project's results"--Publisher's description
