Download or read book Proposal for a Directive of the European Parliament and of the Council on Standards of Quality and Safety of Human Organs Intended for Transplantation and Communication from the Commission Action Plan on Organ Donation and Transplantation 2009 2015 written by and published by . This book was released on 2008 with total page 53 pages. Available in PDF, EPUB and Kindle. Book excerpt: For many patients, organ transplantation represents the only life saving treatment available. There are currently 56,000 patients waiting for a suitable organ donor in the EU. It is estimated that every day 12 people die while waiting for transplantation. The Directive and Action Plan that the Commission proposed addresses 3 key challenges to save lives: improving the quality and safety of organs across Europe, increasing organ availability and making transplant systems more efficient and accessible. EU and Member States will strengthen their cooperation on organ donation and transplantation to provide high quality and safe transplantation systems that citizens and patients across Europe can rely on. The proposal for a Directive provides a clear legal framework for organ donation and transplantation in the European Union. It aims to minimise the risk for the organ transplant recipient, to improve and optimise the allocation of human organs across the European Union and to provide the transplant surgeon with the necessary information to make the best choices. The Action Plan with 10 priority actions addresses the 3 key challenges in organ donation and transplantation in Europe. The Action Plan aims to stimulate joint actions and facilitate coordination with Member States. This will be achieved through different mechanisms such as exchanging good practice or creating EU wide agreements on specific topics. The organ donation and transplantation EU health initiative is part of the Commission's Europe for Patients campaign.
Download or read book Commission Staff Working Document written by and published by . This book was released on 2008 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Impact Assessment on improving organ donation and transplantation across the European Union identifies the major policy options, in order to deal with the main challenges in this field and outlines the rationale for EU action. Four policy options for future EU action are analysed: continue current activities, establish a mechanism to strengthen coordination between Member States and introduce either a flexible or a stringent legal instrument on quality and safety of organs together with a method of cooperation. Economic, social and health impacts are analysed and the possible options for EU action are compared. The Impact Assessment concludes that an integrated approach is the best way to achieve the objectives in the area of organ donation and transplantation: strengthened cooperation between Member States underpinned by a flexible legal framework.
Download or read book Workshop hearing Quality and Safety of Organ Donation and Transplantation written by and published by . This book was released on 2009 with total page 61 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report summarises the presentations and discussions at a Workshop-Hearing on the Quality and Safety of Organ Donation and Transplantation, held at the European Parliament in Brussels on Thursday 19th November 2009. The aim of the workshop was to exchange views on the Commission's 2008 proposal for a Directive of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation (COM(2008) 818 final) and the associated Action Plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States (COM(2008) 819/3).
Download or read book Increasing the Supply of Donor Organs Within the European Union written by Great Britain. Parliament. House of Lords. European Union Committee and published by The Stationery Office. This book was released on 2008 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: In May 2007, the European Commission issued a communication relating to organ donation and transplantation. This made a number of proposals for actions which were designed to help increase the supply of donor organs across the EU. The two major elements were: first, the introduction of a directive aimed at setting standards for the quality and safety of organ donation and transplantation across the EU; and, second, the establishment of an action plan for closer cooperation between Member States in sharing experiences and best practice. This Report brings together evidence relating to the Commission's proposals and draws conclusions about their merits. It also sets out evidence received about a range of matters relating to organ donation which are not within Community competence but which are of central relevance to the shortage of organs for donation: the Organ Donation Taskforce's recent recommendations for the re-organisation of the health infrastructure in the UK; and the proposal, by the Chief Medical Officer for England, that current legislation in England should be changed in order to create a "presumed consent" or "opt-out" system for organ donation in place of the existing "opt-in" system. The Committee's conclusion is that the proposals set out in the Commission's communication would help to raise the numbers of organs available for transplantation as well as the overall safety and quality of those organs. The proposed directive should not be overly bureaucratic and should not inhibit the application of expert clinical judgement and informed patient choice.
Download or read book Regulations Regarding Living Organ Donation in Europe written by Leonie Lopp and published by Springer Science & Business Media. This book was released on 2013-06-12 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Organ transplantation is a much-discussed subject, and the importance of living organ donation is increasing significantly. Yet despite all efforts, too few donor organs are available to help all patients in need. This book analyses whether the national legal regulations are also partly responsible for the organ shortage in the Member States of the European Union. In addition to a detailed analysis of the various national regulations, the main arguments in favour of and against legal restrictions on living organ donation are considered. Furthermore, the European Union’s authority is investigated, namely, whether it is entitled to establish statutory provisions for the Member States with respect to a harmonized regulation of living organ donation. Based on the results of the analysis, the author establishes a Best Practice Proposal for living organ donation.
Download or read book European Union Health Law written by Tamara K. Hervey and published by Cambridge University Press. This book was released on 2015-11-12 with total page 749 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first holistic and thematic study of EU health law, and its implications, through its own internal logics.
Download or read book Organ Shortage written by Anne-Maree Farrell and published by Cambridge University Press. This book was released on 2011-03-10 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: Organ shortage is an ongoing problem in many countries. The needless death and suffering which have resulted necessitate an investigation into potential solutions. This examination of contemporary ethical means, both practical and policy-oriented, of reducing the shortfall in organs draws on the experiences of a range of countries. The authors focus on the resolution and negotiation of ethical conflict, examine systems approaches such as the 'Spanish model' and the US Breakthrough Collaboratives, evaluate policy proposals relating to incentives, presumed consent, and modifications regarding end-of-life care, and evaluate the greatly increased use of (non-heart-beating) donors suffering circulatory death, as well as living donors. The proposed strategies and solutions are not only capable of resolving the UK's own organ-shortage crisis, but also of being implemented in other countries grappling with how to address the growing gap between supply and demand for organs.
Download or read book Increasing the Supply of Donor Organs Within the European Union written by Great Britain. Parliament. House of Lords. European Union Committee and published by The Stationery Office. This book was released on 2008 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evidence taken before Sub-committee G (Social Policy and Consumer Affairs).
Download or read book Organ and Tissue Transplantation in the European Union written by Yvon Englert and published by Martinus Nijhoff Publishers. This book was released on 1995 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part II: Donor screening.
Download or read book Improving Organ Donation and Transplantation in the European Union written by and published by . This book was released on 2008 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to rapid advances in transplantation medicine, the use of human organs for transplantation has steadily increased during the past decades. Organ transplantation is now the most cost-effective treatment for end-stage renal failure and the only available, life-saving treatment for end-stage failure of organs such as liver, lung and heart. The advancement of transplantation medicine has led, however, to a shortage in available organs and poses new quality and safety challenges. Against this background the European Commission aims to improve the availability of organs, ensure their quality and safety, and make transplantation systems more efficient and accessible through European action. In this context the European Commission commissioned RAND Europe to provide support for assessing the impacts of four policy options to improve organ donation and transplantation in the European Union. By taking into account the evidence on possible health, economic and social impacts, this report thus weighs the costs and benefits of the proposed policy options and supports the identification of a preferred policy option to meet DG SANCO's objectives. The qualitative analysis in this report is supplemented by a scenario modelling and benchmarking exercise to address some of the inherent uncertainties related to an impact assessment of relatively broad policy options.
Download or read book Guide to the Quality and Safety of Organs for Transplantation written by and published by . This book was released on 2018 with total page 507 pages. Available in PDF, EPUB and Kindle. Book excerpt:
- Author : Mahmoud Aljurf
- Publisher : Springer Nature
- Release : 2021-02-19
- ISBN : 3030644928
- Pages : 181 pages
Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy
Download or read book Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy written by Mahmoud Aljurf and published by Springer Nature. This book was released on 2021-02-19 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Guide to the Quality and Safety of Tissues and Cells for Human Application written by European Directorate for the Quality of Medicines & Healthcare and published by . This book was released on 2013-10-11 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Regulatory Aspects of Gene Therapy and Cell Therapy Products written by Maria Cristina Galli and published by Springer. This book was released on 2015-09-15 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Download or read book Human Germline Genome Modification and the Right to Science written by Andrea Boggio and published by Cambridge University Press. This book was released on 2022-06-30 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The advent of the CRISPR/Cas9 class of genome editing tools is transforming not just science and medicine, but also law. When the genome of germline cells is modified, the modifications could be inherited, with far-reaching effects in time and scale. Legal systems are struggling with keeping up with the CRISPR revolution and both lawyers and scientists are often confused about existing regulations. This book contains an analysis of the national regulatory framework in eighteen selected countries. Written by national legal experts, it includes all major players in bioengineering, plus an analysis of the emerging international standards and a discussion of how international human rights standards should inform national and international regulatory frameworks. The authors propose a set of principles for the regulation of germline engineering, based on international human rights law, that can be the foundation for regulating heritable gene editing both at the level of countries as well as globally.
Download or read book Council of Europe Convention Against Trafficking in Human Organs and Explanatory Report written by Council of Europe and published by . This book was released on 2016 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: Trafficking in human organs is an emerging criminal activity which presents a clear danger to both individual and public health, while breaching human rights and fundamental freedoms. The Council of Europe Convention against Trafficking in Human Organs seeks to protect individual rights by addressing this illegal act from a criminal law perspective. The Convention aims to tackle this crime both at national and international levels by harmonising national legislation, identifying the various offences that constitute trafficking in human organs and laying down the foundation for more efficient cross-border co-operation. It also covers preventive measures and the legal situation of the victims. Wide accession to the Convention is essential in the fight against a crime that is, more often than not, transnational in scope.
Download or read book Living Donor Kidney Transplantation written by Jonas Wadström and published by CRC Press. This book was released on 2005-07-14 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: Living donor kidney (LDK) transplantation has become the definitive approach to the treatment of end-stage renal failure, providing a better quality of life and the best opportunity for survival when compared with dialysis or transplantation from a deceased donor. A timely compendium of the modern day practice of LDK transplantation from a group of