All those who manage the quality system must "undergo" inspections and audits by regulatory or certification bodies (JACIE, CNT, CNS, CRS, CRT).
During this meeting, strategies and operational tools will be provided to effectively prepare for the various inspections.

Quality standards increasingly require centers to implement internally a system aimed at validation and validation. One of the elements that must be validated in a transplant center, transfusion service and fertilization center is the IT system.
During this path, the validation method of IT systems will be illustrated, providing operational tools for the validation itself.

The aim of the course is to maintain the level of qualification for all those who work in the CAR-T Unit and Cell Therapy Unit.

In particular, during the training course, the center's compliance will be analyzed in light of current European and national legislation, examining the necessary requirements required by the legislation.

Furthermore, the role of the "Car-T Specialist" and the Gene Therapy Expert in the two is illustrated
job prospects: sponsoring company and clinical center.

The course aims to analyze the method of application of the requirements required by the
GDPR within transplant centers, tissue institutes and ART centers.
After having addressed the issue of the GDPR on a general level, we will proceed to illustrate the main problems present at the regulatory level in the specific reality.