Regulatory Aspects of Gene Therapy and Cell Therapy Products A Global Perspective /
This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as...
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| Natura: | Elettronico eBook |
| Lingua: | inglese |
| Pubblicazione: |
Cham :
Springer International Publishing : Imprint: Springer,
2023.
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| Edizione: | 2nd ed. 2023. |
| Serie: | Advances in Experimental Medicine and Biology,
1430 |
| Soggetti: | |
| Accesso online: | https://doi.org/10.1007/978-3-031-34567-8 |
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Sommario:
- Introduction (MCG and FN)
- Updates on ATMP regulations from EU: experience with PRIME procedure and list of approved ATMP
- EU portal for clinical trials application
- European Pharmacopoeia texts on gene therapy medicinal products
- Updates on ATMP regulations from UK after Brexit and list of approved ATMP
- Updates on ATMP regulations from Switzerland and list of approved ATMP
- Updates on ATMP regulations from US FDA: experience with breakthrough/accelerated procedures and list of approved ATMP
- Updates on ATMP regulations from Canada and list of approved ATMP
- Updates on ATMP regulations from Brasil and list of approved ATMP
- Updates on ATMP regulations from Singapore and list of approved ATMP
- Updates on ATMP regulations from Japan: experience with new law and list of approved ATMP
- Updates on ATMP regulations from South Korea and list of approved ATMP
- Updates on ATMP regulations from Taiwan and list of approved ATMP
- Updates on ATMP regulations from Thailand and listof approved ATMP
- ATMP regulations in China and list of approved ATMP
- ATMP regulations in Australia and list of approved ATMP
- ATMP regulations in India and list of approved ATMP
- International harmonization programs. .