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Regulatory Aspects of Gene Therapy and Cell Therapy Products

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Cover of 'Regulatory Aspects of Gene Therapy and Cell Therapy Products'

Table of Contents

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    Book Overview
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    Chapter 1 United States Food and Drug Administration Regulation of Gene and Cell Therapies
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    Chapter 2 The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety
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    Chapter 3 Regulatory Oversight of Cell and Gene Therapy Products in Canada
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    Chapter 4 Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products
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    Chapter 5 Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany
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    Chapter 6 Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.
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    Chapter 7 Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland
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    Chapter 8 Regulatory Frameworks for Gene and Cell Therapies in Japan
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    Chapter 9 Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea
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    Chapter 10 Regulation of Cell and Gene Therapy Medicinal Products in Taiwan
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    Chapter 11 Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore
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    Chapter 12 The Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built
Attention for Chapter 4: Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products
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