Preclinical and the basic principles of statistical analysis will be presented and their applications to C&GT therapeutic products

The students will accept a background on the different phases a C&GT 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

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