
Title:
Regulatory Aspects of Gene Therapy and Cell Therapy Products A Global Perspective
Author:
Galli, Maria Cristina. editor.
ISBN:
9783031345678
Edition:
2nd ed. 2023.
Physical Description:
IX, 242 p. 37 illus., 36 illus. in color. online resource.
Series:
Advances in Experimental Medicine and Biology, 1430
Contents:
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. .
Added Author:
Added Corporate Author:
Electronic Access:
https://doi.org/10.1007/978-3-031-34567-8Copies:
Available:*
Library | Material Type | Item Barcode | Shelf Number | Status | Item Holds |
|---|---|---|---|---|---|
Searching... | E-Book | 527565-1001 | ONLINE | Searching... | Searching... |
