Regulatory Aspects of Gene Therapy and Cell Therapy Products A Global Perspective /

• Corporate Author: SpringerLink (Online service)
• Other Authors: Galli, Maria Cristina (Editor), Serabian, Mercedes (Editor)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2015.
• Series: Advances in Experimental Medicine and Biology, 871
• Subjects: Medicine.; Gene therapy.; Biomedicine.; Gene Therapy.

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Table of Contents:

• 1. Regulatory Oversight of Gene Therapy and Cell Therapy Products in the US - FDA/CBER
• 2. US Oversight of Gene Therapy Products – NIH RAC
• 3. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Canada - Health Canada
• 4. Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products
• 5. Regulation of Clinical Trials with Advanced Therapy Medicinal Products (ATMP) in Germany
• 6. EU Clinical Trials Regulatory Oversight of Advanced Therapy Medicinal Products (ATMP): Perspectives from Various Member States
• 7. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Switzerland - Swissmedic
• 8. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Japan - Japan Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Device Agency (PMDA)
• 9. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea - Korean Ministry of Food and Drug Safety (MFDS)
• 10. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Taiwan - Taiwan Food and Drug Administration (TFDA)
• 11. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Singapore - Singapore Health Science Authorities (HSA)
• 12. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Brazil - National Health Surveillance Agency (ANVISA).