Regulatory Aspects of Gene Therapy and Cell Therapy Products

<p>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).</p>