Regulatory Aspects of Gene Therapy and Cell Therapy Products : A Global Perspective /
| Autor Corporativo: | |
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| Otros Autores: | , |
| Formato: | eBook |
| Lenguaje: | English |
| Publicado: |
Cham :
Springer International Publishing : Imprint: Springer,
2015.
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| Edición: | 1st ed. 2015. |
| Colección: | American Society of Gene & Cell Therapy,
871 |
| Materias: |
Tabla de Contenidos:
- 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).