Preclinical and the basic principles of statistical analysis will be presented and their applications to C> therapeutic products
The students will accept a background on the different phases a C> should go through with the regulatory authorities – locally and globally. What are the needs at each phase and hoe we provide the best quality to the patients.
Historical overview of current CGT
Current status of CGT clinical trials and commercialized therapies
Pre-clinical studies design
Clinical studies design: How to write a clinical protocol for CGT
Introduction to clinical trials
How to get a CGT cell program started
Donor and patient eligibility
Apheresis / Cell procurement
Good clinical practice in CGT treatment
How to monitor clinical trials
Report of CGT treatments and side effects
