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Titlebook: Regulation of Genome Editing in Human iPS Cells; A Comparative Legal Hans-Georg Dederer,Gregor Frenken Book 2022 The Editor(s) (if applica

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Comparative Analysis,rerequisites, and requirements specifically addressed to the use of genetically modified organisms (GMOs). In addition, the comparative analysis relates to treatments in the absence of prior marketing authorizations for the medicinal products administered to the patients concerned. Such therapeutic
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Introductory Remarks,oject. At the core of the project are two basic scenarios for the future treatment of hereditary diseases. The envisaged treatments may constitute either germ line therapies or somatic cell/gene therapies. Genome editing, especially by means of CRISPR/Cas, and induced pluripotent stem cells (iPSCs)
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Regulation of Genome Editing in Human iPS Cells: France,f Europe treaties, and French laws) which are under continual development. Several relevant rules can be identified regarding the access to human biological material (cells, tissues and genes and more specifically somatic cells, germ cells, embryonic cells and embryos) as well as the modalities of t
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Regulation of Genome Editing in Human iPS Cells: Switzerland, specific regulations regarding iPSCs or genome editing in human cells, several norms apply. According to the Transplantation Ordinance, human iPSCs, as well as any gene/cell therapy using them, qualify as transplant products. Therefore, their handling needs to be authorised as described in the pres
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Regulation of Genome Editing in Human iPS Cells: United States,amework which fosters research on, as well as development, application and marketing of, cell and gene therapy (CGT) products without compromising their safety, efficacy and quality. The applicable framework is product-based, i.e. its rules apply independent of the processes used to manufacture the
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