Regulatory Aspects of Gene Therapy and Cell Therapy Products A Global Perspective
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodie...
| Other Authors: | , |
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| Format: | eBook |
| Language: | English |
| Published: |
Cham
Springer International Publishing
2015, 2015
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| Edition: | 1st ed. 2015 |
| Series: | American Society of Gene & Cell Therapy
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| Subjects: | |
| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
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 Ministryof 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)