國立高雄大學圖資館 |

登入

回首頁

Regulation of genome editing in human iPS cellsa comparative legal analysis of national regulatory frameworks for IPSC-based cell/gene therapies /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Regulation of genome editing in human iPS cellsedited by Hans-Georg Dederer, Gregor Frenken.
其他題名:	a comparative legal analysis of national regulatory frameworks for IPSC-based cell/gene therapies /
其他作者:	Dederer, Hans-Georg.
出版者:	Cham :Springer International Publishing :2022.
面頁冊數:	x, 334 p. :ill., digital ;24 cm.
Contained By:	Springer Nature eBook
標題:	Gene editingLaw and legislation.
電子資源:	https://doi.org/10.1007/978-3-030-93023-3
ISBN:	9783030930233$q(electronic bk.)

Regulation of genome editing in human iPS cellsa comparative legal analysis of national regulatory frameworks for IPSC-based cell/gene therapies /
Regulation of genome editing in human iPS cellsa comparative legal analysis of national regulatory frameworks for IPSC-based cell/gene therapies /[electronic resource] :edited by Hans-Georg Dederer, Gregor Frenken. - Cham :Springer International Publishing :2022. - x, 334 p. :ill., digital ;24 cm.

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.

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.

ISBN: 9783030930233$q(electronic bk.)

Standard No.: 10.1007/978-3-030-93023-3doiSubjects--Topical Terms:

922461
Gene editing
--Law and legislation.

LC Class. No.: K3611.G46

Dewey Class. No.: 344.04196

Regulation of genome editing in human iPS cellsa comparative legal analysis of national regulatory frameworks for IPSC-based cell/gene therapies /
LDR:03335nmm a2200349 a 4500 001 621345
003 DE-He213
005 20220523120210.0
006 m d
007 cr nn 008maaau
008 221121s2022 sz s 0 eng d
020 $a 9783030930233$q(electronic bk.)
020 $a 9783030930226$q(paper)
024 7 $a 10.1007/978-3-030-93023-3 $2 doi
035 $a 978-3-030-93023-3
040 $a GP $c GP
041 0 $a eng
050 4 $a K3611.G46
072 7 $a LB $2 bicssc
072 7 $a LAM $2 bicssc
072 7 $a LAW051000 $2 bisacsh
072 7 $a LB $2 thema
072 7 $a LAM $2 thema
082 0 4 $a 344.04196 $2 23
090 $a K3611.G46 $b R344 2022
245 0 0 $a Regulation of genome editing in human iPS cells $h [electronic resource] : $b a comparative legal analysis of national regulatory frameworks for IPSC-based cell/gene therapies / $c edited by Hans-Georg Dederer, Gregor Frenken.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2022.
300 $a x, 334 p. : $b ill., digital ; $c 24 cm.
505 0 $a 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.
520 $a 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.
650 0 $a Gene editing $x Law and legislation. $3 922461
650 1 4 $a Private International Law, International and Foreign Law, Comparative Law. $3 913280
650 2 4 $a European Law. $3 558717
650 2 4 $a Medical Genetics. $3 911830
700 1 $a Dederer, Hans-Georg. $3 878695
700 1 $a Frenken, Gregor. $3 922460
710 2 $a SpringerLink (Online service) $3 273601
773 0 $t Springer Nature eBook
856 4 0 $u https://doi.org/10.1007/978-3-030-93023-3
950 $a Law and Criminology (SpringerNature-41177)