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Secretariat of the Convention on Biological Diversity. Nagoya Protocol On Access To Genetic Resources And The Fair And Equitable Sharing Of Benefits Arising From Their Utilization To The Convention On Biological Diversity. Canada, 2011. ISBN: 92-9225-306-9.

Genetic Resources Nagoya Protocol Translational Research

The Protocol provides
a strong basis for greater legal certainty and transparency for both providers
and users of genetic resources. It also promotes the use of genetic resources and associated traditional knowledge, strengthens the opportunities for fair and equitable sharing of benefits from their use.

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Council of the European Union. Recommendations R (92) 3 on the Genetic Testing and Screening for Health Care Purposes (CoE 1992).

Published by Council of Europe

Genetic Testing and Screening

The major general aim of this document is to contribute to the discussion of a consensus definition of Genetic testing and of its global applicability.

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Council of the European Union. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Genetic Testing for Health Purposes, 2008.

Published by Council of Europe

Genetic Testing Human Rights

The first international legally binding instrument concerning genetic testing for health purposes was adopted by the Committee of Ministers of the Council of Europe.

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Guidance on paediatric submissions Via Syncplicity Web Client

Published by European Medicines Agency

Paediatric Investigation Plan Paediatric Submission

The guidance outlines the main steps to take in preparation for submission and a list of documents required for the main1 types of paediatric submissions.

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European Medicines Agency. Committee for Advanced Therapies (CAT). Guideline on Quality, Non-Clinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells. 3 November 2020. EMA/CAT/GTWP/671639/2008 Rev. 1

Published by EMA

Clinical Aspects Genetically Modified Cell Guideline Non-Clinical Quality

Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

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European Commission. GUIDELINES on Good Clinical Practice Specific to Advanced Therapy Medicinal Products. Brussels, 10.10.2019. C(2019) 7140 Final.

Published by European Commission (EC)

Advanced Therapy Good Clinical Practice

European Commission. GUIDELINES on Good Clinical Practice specific to Advanced Therapy Medicinal Products. Brussel

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COM(2016)223 – Implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells.

Published by European Commission (EC)

Human Tissues and Cells Quality and Safety

The report scope is the standards of quality and safety for human tissues and cells.

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COMMISSION DIRECTIVE (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance)

Published by European Commission (EC)

Human Tissue and Cells Technical Requirements

This Comission Directive sets up measures concerning traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.

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COMMISSION DIRECTIVE 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.

Published by European Commission (EC)

Donation Human Tisssue and Cells Technical Requirements Testing

This Directive that set the technical requirements for the donation, procurement and testing of human tissues and cells.

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DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

Published by European Commission (EC)

Distribution Donation Human Tissues and Cells Preservation Processing Quality and Safety

This Directive sets the standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

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Secretariat of the Convention on Biological Diversity. Nagoya Protocol On Access To Genetic Resources And The Fair And Equitable Sharing Of Benefits Arising From Their Utilization To The Convention On Biological Diversity. Canada, 2011. ISBN: 92-9225-306-9.

Council of the European Union. Recommendations R (92) 3 on the Genetic Testing and Screening for Health Care Purposes (CoE 1992).

Council of the European Union. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Genetic Testing for Health Purposes, 2008.

Guidance on paediatric submissions Via Syncplicity Web Client

European Medicines Agency. Committee for Advanced Therapies (CAT). Guideline on Quality, Non-Clinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells. 3 November 2020. EMA/CAT/GTWP/671639/2008 Rev. 1

European Commission. GUIDELINES on Good Clinical Practice Specific to Advanced Therapy Medicinal Products. Brussels, 10.10.2019. C(2019) 7140 Final.

COM(2016)223 – Implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells.

COMMISSION DIRECTIVE (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance)

COMMISSION DIRECTIVE 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.

DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.