Regulatory Aspects of Gene Therapy and Cell Therapy Products : A Global Perspective - Galli, Maria Cristina; Serabian, Mercedes; SpringerLink (Online service) (Cham : Springer International Publishing : Imprint: Springer, 2015)
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).
Keywords: Gene therapy; Gene Therapy