MARC details
| 000 -LEADER |
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| fixed length control field |
03453nam a22003015i 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
220523s2022 sz | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9783030930233 |
| -- |
978-3-030-93023-3 |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Classification number |
340.9 |
| Edition number |
23 |
| 245 10 - TITLE STATEMENT |
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| Title |
Regulation of Genome Editing in Human iPS Cells |
| Medium |
[electronic resource] : |
| Remainder of title |
A Comparative Legal Analysis of National Regulatory Frameworks for iPSC-based Cell/Gene Therapies / |
| Statement of responsibility, etc. |
edited by Hans-Georg Dederer, Gregor Frenken. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
1st ed. 2022. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
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| Place of production, publication, distribution, manufacture |
Cham : |
| Name of producer, publisher, distributor, manufacturer |
Springer International Publishing : |
| -- |
Imprint: Springer, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2022. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
X, 334 p. 13 illus., 10 illus. in color. |
| Other physical details |
online resource. |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
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 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
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 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Private international law. |
| 9 (RLIN) |
1163420 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Conflict of laws. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
International law. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Comparative law. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Law-Europe. |
| 9 (RLIN) |
1465530 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Medical genetics. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Private International Law, International and Foreign Law, Comparative Law. |
| 9 (RLIN) |
1464650 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
European Law. |
| 9 (RLIN) |
1465531 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Medical Genetics. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Dederer, Hans-Georg. |
| Relator term |
editor. |
| 9 (RLIN) |
1470102 |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Frenken, Gregor. |
| Relator term |
editor. |
| 9 (RLIN) |
1470103 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
<a href="https://doi.org/10.1007/978-3-030-93023-3">https://doi.org/10.1007/978-3-030-93023-3</a> |
| Materials specified |
Click Here |
| 887 ## - NON-MARC INFORMATION FIELD |
|---|
| Content of non-MARC field |
Akhil Chandra Saren |
