CMC Considerations for CAR T Cell Product Development

4 Просмотры
Издатель
FDA discusses the CMC requirements for CAR T Cell Product IND submissions, including early product development and product characterization for both autologous and allogenic products.
Presenter:
Kimberly Schultz, PhD, Gene Therapy Reviewer, Division of Cellular & Gene Therapies, Office of Tissues and Advanced Therapies (OTAT), CBER

Learn more at:
-------------------- 
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
Upcoming Training -    
SBIA Listserv -
SBIA 2021 Playlist -
SBIA LinkedIn -   
SBIA Training Resources -   
Twitter -   
Email - CDERSBIA@  
Phone - (301) 796-6707 I (866) 405-5367
Категория
Мировое кино
Комментариев нет.