BookMaria Cristina Galli, Mercedes Serabian, editors.
Contents:
United States Food and Drug Administration Regulation of Gene and Cell Therapies
The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety
Regulatory Oversight of Cell and Gene Therapy Products in Canada
Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products
Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany
Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective
Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland
Regulatory Frameworks for Gene and Cell Therapies in Japan
Regulatory Oversight of Gene Therapy and Cell Therapy
Regulation of Cell and Gene Therapy Medicinal Products in Taiwan
Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore
The Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built
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