| 書目名稱 | Regulation of Genome Editing in Human iPS Cells | | 副標(biāo)題 | A Comparative Legal | | 編輯 | Hans-Georg Dederer,Gregor Frenken | | 視頻video | http://file.papertrans.cn/826/825677/825677.mp4 | | 概述 | Identifies pros and cons so as to provide advice to lawmakers and regulators.Analysis of the legal frameworks which provides insight into regulatory concepts.Scientific introduction into iPS cell tech | | 圖書封面 |  | | 描述 | 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 anal | | 出版日期 | Book 2022 | | 關(guān)鍵詞 | ATMP; ATMP regulation; iPS cells; Genome-edited iPS cells; Human genome editing; Somatic genome editing; G | | 版次 | 1 | | doi | https://doi.org/10.1007/978-3-030-93023-3 | | isbn_softcover | 978-3-030-93025-7 | | isbn_ebook | 978-3-030-93023-3 | | copyright | The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl |
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