Author: Great Britain
Publisher:
ISBN: 9780110771526
Category : Law
Languages : en
Pages : 24
Book Description
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
The Human Tissue (Quality and Safety for Human Application) Regulations 2007
Author: Great Britain
Publisher:
ISBN: 9780110771526
Category : Law
Languages : en
Pages : 24
Book Description
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
Publisher:
ISBN: 9780110771526
Category : Law
Languages : en
Pages : 24
Book Description
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
HUMAN TISSUE (AMENDMENT) REGULATIONS 2018
Author: GREAT BRITAIN.
Publisher:
ISBN: 9780111167106
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9780111167106
Category :
Languages : en
Pages :
Book Description
The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2014
Author: Great Britain
Publisher:
ISBN: 9780111122754
Category :
Languages : en
Pages :
Book Description
Enabling power: European Communities Act 1972, s. 2 (2). Issued: 07.11.2014. Made: 29.10.2014. Laid: -07.11.2014. Coming into force: 15.12.2014. Effect: S.I. 2007/1523 amended. Territorial extent & classification: E/W/S/NI. General. EC note: These Regulations amend SI 2007/1523 in order to transpose Commission Directive 2012/39/EU as regards certain technical requirements for the testing of human tissues and cells
Publisher:
ISBN: 9780111122754
Category :
Languages : en
Pages :
Book Description
Enabling power: European Communities Act 1972, s. 2 (2). Issued: 07.11.2014. Made: 29.10.2014. Laid: -07.11.2014. Coming into force: 15.12.2014. Effect: S.I. 2007/1523 amended. Territorial extent & classification: E/W/S/NI. General. EC note: These Regulations amend SI 2007/1523 in order to transpose Commission Directive 2012/39/EU as regards certain technical requirements for the testing of human tissues and cells
The Human Tissue (Quality and Safety for Human Application) (Amendment)
Draft Human Fertilisation and Embryology (Quality and Safety) Regulations 2007; Draft Human Tissue (Quality and Safety for Human Application) Regulations 2007
Author: Great Britain: Parliament: House of Commons: 1st Delegated Legislation Committee
Publisher:
ISBN: 9780215785091
Category :
Languages : en
Pages :
Book Description
Draft Human Fertilisation and Embryology (Quality and Safety) Regulations 2007; draft Human Tissue (Quality and Safety for Human Application) Regulations 2007 : Monday 21 May 2007
Publisher:
ISBN: 9780215785091
Category :
Languages : en
Pages :
Book Description
Draft Human Fertilisation and Embryology (Quality and Safety) Regulations 2007; draft Human Tissue (Quality and Safety for Human Application) Regulations 2007 : Monday 21 May 2007
Guide to the Quality and Safety of Tissues and Cells for Human Application
Author: European Directorate for the Quality of Medicines
Publisher:
ISBN: 9789287189455
Category :
Languages : en
Pages : 666
Book Description
Publisher:
ISBN: 9789287189455
Category :
Languages : en
Pages : 666
Book Description
Guide to the Quality and Safety of Tissues and Cells for Human Application
Author: European Directorate for the Quality of Medicines & Healthcare
Publisher:
ISBN: 9789287176394
Category : Cell transplantation
Languages : en
Pages : 320
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
Publisher:
ISBN: 9789287176394
Category : Cell transplantation
Languages : en
Pages : 320
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
Legal Basis Of Global Tissue Banking: A Proactive Clinical Perspective
Author: Glyn O Phillips
Publisher: World Scientific
ISBN: 981466345X
Category : Law
Languages : en
Pages : 305
Book Description
The banking of human tissues for clinical transplantation has grown exponentially in the past 10-15 years. Tissue banks have been set up throughout the world, initially on an ad hoc basis. More recently these have grown and in many countries have linked up with larger international companies. While standards for the procurement, processing and storage of the tissues have kept pace with the growth of the subject, this is not so with the legal considerations associated with the practice. There is no unified legal system which is internationally operated. Europe, USA, Asia, Latin America, China have been developing legal systems on an individual basis.This book describes the present state of the development of laws to control and make the banking and use of tissues legal and safe. It describes, for the first time, the current systems which are used throughout the world and points the way to setting up a harmonized global legal system.
Publisher: World Scientific
ISBN: 981466345X
Category : Law
Languages : en
Pages : 305
Book Description
The banking of human tissues for clinical transplantation has grown exponentially in the past 10-15 years. Tissue banks have been set up throughout the world, initially on an ad hoc basis. More recently these have grown and in many countries have linked up with larger international companies. While standards for the procurement, processing and storage of the tissues have kept pace with the growth of the subject, this is not so with the legal considerations associated with the practice. There is no unified legal system which is internationally operated. Europe, USA, Asia, Latin America, China have been developing legal systems on an individual basis.This book describes the present state of the development of laws to control and make the banking and use of tissues legal and safe. It describes, for the first time, the current systems which are used throughout the world and points the way to setting up a harmonized global legal system.
Human Tissue and Embryos (draft) Bill
Author: Great Britain: Department of Health
Publisher: The Stationery Office
ISBN: 9780101708722
Category : Medical
Languages : en
Pages : 250
Book Description
The Government set out detailed policy proposals for changes to the Human Fertilisation and Embryology Act 1990 in its White Paper (Cm.6989, ISBN 9780101698924) published in December 2006. These proposed changes to the law and regulation relating to human reproductive technologies, following on from a public consultation exercise undertaken during 2005, sought to balance the competing claims of reproductive liberty and responsibility, patient safety, child welfare, professional autonomy and public accountability. The overarching aim is to achieve the common good through a system which is broadly acceptable to society, given the complex ethical issues involved, and which is effective given the pace of scientific developments. This present document contains the draft text of the proposed Human Tissue and Embryos Bill, published in order to enable pre-legislative scrutiny of the proposals by a Parliamentary Committee. It includes the text of the draft Bill, explanatory notes, a draft regulatory impact assessment and a version of how the Human Fertilisation and Embryology Act would look if amended by the draft Bill and the EU Tissue Directive. The proposals include the creation of the new single regulatory authority on the use of human tissue, cells and blood, to be called the Regulatory Authority for Tissue and Embryos (RATE), to replace the Human Fertilisation and Embryology Authority and the Human Tissue Authority.
Publisher: The Stationery Office
ISBN: 9780101708722
Category : Medical
Languages : en
Pages : 250
Book Description
The Government set out detailed policy proposals for changes to the Human Fertilisation and Embryology Act 1990 in its White Paper (Cm.6989, ISBN 9780101698924) published in December 2006. These proposed changes to the law and regulation relating to human reproductive technologies, following on from a public consultation exercise undertaken during 2005, sought to balance the competing claims of reproductive liberty and responsibility, patient safety, child welfare, professional autonomy and public accountability. The overarching aim is to achieve the common good through a system which is broadly acceptable to society, given the complex ethical issues involved, and which is effective given the pace of scientific developments. This present document contains the draft text of the proposed Human Tissue and Embryos Bill, published in order to enable pre-legislative scrutiny of the proposals by a Parliamentary Committee. It includes the text of the draft Bill, explanatory notes, a draft regulatory impact assessment and a version of how the Human Fertilisation and Embryology Act would look if amended by the draft Bill and the EU Tissue Directive. The proposals include the creation of the new single regulatory authority on the use of human tissue, cells and blood, to be called the Regulatory Authority for Tissue and Embryos (RATE), to replace the Human Fertilisation and Embryology Authority and the Human Tissue Authority.
Biobanks and Tissue Research
Author: Christian Lenk
Publisher: Springer Science & Business Media
ISBN: 9400716737
Category : Medical
Languages : en
Pages : 240
Book Description
The research field of biobanks and tissue research is highly promising. Many projects around the globe are involved in the collection of human tissue and health data for research purposes. These initiatives are driven by the perspective of decisive breakthroughs in the knowledge of the genetic pathways involved in widespread diseases. However, there are considerable ethical and legal challenges to be considered as well. These challenges encompass the use of body material for research purposes, the misuse of genetic and other health data by third parties, trust in science and medicine, concerns regarding privacy, use of genetic data for forensic applications by the state and the police, and regulatory issues. This volume is divided into three parts: the inclusion of the public, the rights of donors and patients, examples and recommendations for the future of tissue research. It presents a comprehensive overview of the most important topics in the field by renowned scholars in medical ethics and biolaw.
Publisher: Springer Science & Business Media
ISBN: 9400716737
Category : Medical
Languages : en
Pages : 240
Book Description
The research field of biobanks and tissue research is highly promising. Many projects around the globe are involved in the collection of human tissue and health data for research purposes. These initiatives are driven by the perspective of decisive breakthroughs in the knowledge of the genetic pathways involved in widespread diseases. However, there are considerable ethical and legal challenges to be considered as well. These challenges encompass the use of body material for research purposes, the misuse of genetic and other health data by third parties, trust in science and medicine, concerns regarding privacy, use of genetic data for forensic applications by the state and the police, and regulatory issues. This volume is divided into three parts: the inclusion of the public, the rights of donors and patients, examples and recommendations for the future of tissue research. It presents a comprehensive overview of the most important topics in the field by renowned scholars in medical ethics and biolaw.