000			03453nam a22003015i 4500
008			220523s2022 sz | s |||| 0|eng d
020			_a9783030930233 _9978-3-030-93023-3
082	0	4	_a340.9 _223
245	1	0	_aRegulation of Genome Editing in Human iPS Cells _h[electronic resource] : _bA Comparative Legal Analysis of National Regulatory Frameworks for iPSC-based Cell/Gene Therapies / _cedited by Hans-Georg Dederer, Gregor Frenken.
250			_a1st ed. 2022.
264		1	_aCham : _bSpringer International Publishing : _bImprint: Springer, _c2022.
300			_aX, 334 p. 13 illus., 10 illus. in color. _bonline resource.
505	0		_aIntroduction -- 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.
520			_aThe 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.
650		0	_aPrivate international law. _91163420
650		0	_aConflict of laws.
650		0	_aInternational law.
650		0	_aComparative law.
650		0	_aLaw-Europe. _91465530
650		0	_aMedical genetics.
650	1	4	_aPrivate International Law, International and Foreign Law, Comparative Law. _91464650
650	2	4	_aEuropean Law. _91465531
650	2	4	_aMedical Genetics.
700	1		_aDederer, Hans-Georg. _eeditor. _91470102
700	1		_aFrenken, Gregor. _eeditor. _91470103
856	4	0	_uhttps://doi.org/10.1007/978-3-030-93023-3 _3Click Here
887			_aAkhil Chandra Saren
999			_c1582012 _d1582012