Regulatory Aspects of Gene Therapy and Cell Therapy Products, Kartoniert / Broschiert
Regulatory Aspects of Gene Therapy and Cell Therapy Products
- A Global Perspective
(soweit verfügbar beim Lieferanten)
- Herausgeber:
- Maria Cristina Galli
- Verlag:
- Springer, 08/2024
- Einband:
- Kartoniert / Broschiert, Paperback
- Sprache:
- Englisch
- ISBN-13:
- 9783031345692
- Artikelnummer:
- 11946725
- Umfang:
- 252 Seiten
- Nummer der Auflage:
- 24002
- Ausgabe:
- Second Edition 2023
- Gewicht:
- 482 g
- Maße:
- 254 x 178 mm
- Stärke:
- 14 mm
- Erscheinungstermin:
- 20.8.2024
- Hinweis
-
Achtung: Artikel ist nicht in deutscher Sprache!
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Klappentext
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.
