Titlebook: Cell Therapy; cGMP Facilities and Adrian P. Gee Book 2022Latest edition Springer Nature Switzerland AG 2022 cell processing facilities.cel

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G. Di Pillo,L. Grippo,F. Lampariellor medical therapies and studies, and for products. Providing regenerative medicines by strictly complying with applicable regulations is compulsory. In this section, the Japanese regulatory framework for regenerative medicines is briefly described.

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Landscape for Regenerative Medicine Manufacturing in Japanr medical therapies and studies, and for products. Providing regenerative medicines by strictly complying with applicable regulations is compulsory. In this section, the Japanese regulatory framework for regenerative medicines is briefly described.

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Investigational New Drug Applications for Cell Therapy Productsch. It is important to note that these types of trials are regulated differently throughout the world and that if a study is to be conducted outside of the USA, a thorough review of regulations governing that country will be required. This chapter reviews the process for submitting an Investigational New Drug application to the FDA.

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G. Di Pillo,L. Grippo,F. Lamparielloraised by those offered outside of regulatory frameworks. A discussion of ethical challenges in cell therapy clinical trial design is included. The chapter concludes with ethical considerations pertaining to the procurement and use of pluripotent stem cells: human embryonic stem cells and induced pluripotent stem cells.

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Springer Nature Switzerland AG 2022