Αρχειοθήκη ιστολογίου

Αλέξανδρος Γ. Σφακιανάκης
ΩτοΡινοΛαρυγγολόγος
Αναπαύσεως 5
Άγιος Νικόλαος Κρήτη 72100
2841026182
6032607174

Κυριακή 19 Δεκεμβρίου 2021

CAR-T CELLS: How does the EBMT registry monitor European activities, identify hurdles and prepare for changes in regulations

xlomafota13 shared this article with you from Inoreader

Bull Cancer. 2021 Oct;108(10S):S155-S161. doi: 10.1016/j.bulcan.2021.08.004.

ABSTRACT

CAR-T Cells are gene therapy medicinal products, a subcategory of Advanced Therapy Medicinal Products as defined in the EC Regulation 1394/2007. They may represent the first example of such medicinal products that are industry-manufactured and commercialized on a large scale. Their very nature, their manufacturing processes, pricing and conditions upon which they were approved by regulatory agencies, all lead the latter to require long-term follow-up after marketing approval with a view for a better definition of CAR-T Cells safety profile and efficacy profile in real world conditions. Collection and analysis of data over a 15-year period of time represents a technical and political challenge. So does the a priori definition of data to be collected for a wealth of forthcoming analyses that focus on the interests of a variety of stakeholders. EBMT has been collecting and analyzing data on hematopoietic cell transplants for decades. EBMT currently works with many interested parties to collect data on patients treated with CAR-T Cells.

PMID:34920798 | DOI:10.1016/j.bulcan.2021.08.004

View on the web

Δεν υπάρχουν σχόλια:

Δημοσίευση σχολίου