Regulation of genome editing in human iPS cells : a comparative legal analysis of national regulatory frameworks for IPSC-based cell/gene therapies / Hans-Georg Dederer, Gregor Frenken, editors.
Dederer, Hans-Georg.; Frenken, Gregor.
2022
K3611.G46
Available Online

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Title Regulation of genome editing in human iPS cells : a comparative legal analysis of national regulatory frameworks for IPSC-based cell/gene therapies / Hans-Georg Dederer, Gregor Frenken, editors.
ISBN 3030930238 (electronnic bk.)
9783030930233 (electronic bk.)
9783030930226
303093022X
DOI https://doi.org/10.1007/978-3-030-93023-3
Publication Details Cham, Switzerland : Springer, 2022.
Language English
Description 1 online resource (340 pages)
Item Number 10.1007/978-3-030-93023-3 doi
Call Number K3611.G46
Dewey Decimal Classification 344.04/196
Summary The book provides a concise overview of currently applicable regulatory frameworks of states which are among the world leaders in research and development (R & D) of cell and gene therapies. Developments in genome editing are expected to lead to new possibilities for the treatment of hereditary diseases in humans. The treatment of such often severe but hitherto uncurable diseases can be based on genome-edited induced pluripotent stem cells (iPS cells). Such treatments constitute combined cell/gene therapies. These therapies need to be governed by a regulatory framework which ensures quality, safety, and efficacy of the relevant therapeutic products. On the other hand, such regulations may retard product approval and impede R & D. Accordingly, national regulations for therapies based on genome-edited iPS cells are an important and, as the case may be, decisive factor for both researchers and industry regarding their decision where to locate their R & D activities. Therefore, regulatory frameworks impact significantly on the competitiveness of states and their economies. This is why a comparative analysis of laws and regulations of different countries matters. Such a comparative legal analysis provides an important insight into regulatory concepts which, in turn, may inspire adjustments of, or amendments to, domestic legal regimes. For this purpose, experts present country reports on France, Germany, Japan, South Korea, Switzerland, and the USA. The reports on France and Germany also refer to the parameters and implications arising from pertinent EU law. This contributed volume is aimed at researchers, but also at, e.g., legal scholars, lawmakers, regulators, and political decision makers.
Access Note Access limited to authorized users.
Source of Description Online resource; title from PDF title page (SpringerLink, viewed June 9, 2022).
Added Author Dederer, Hans-Georg.
Frenken, Gregor.
Available in Other Form Regulation of Genome Editing in Human IPS Cells.
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Introduction
Biological aspects of genome editing in iPS cells
Ethical aspects in the context of genome editing
Regulation of genome editing in iPS cells : Germany
Regulation of genome editing in iPS cells : France
Regulation of genome editing in iPS cells : Switzerland
Regulation of genome editing in iPS cells : United States
Regulation of genome editing in iPS cells : Japan
Regulation of genome editing in iPS Cells : Republic of Korea
Comparative analysis.

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