AbstractCell therapy is a complex field, with a plethora of therapeutic procedures that widely differ among and within countries. An effective and efficient quality management (QM) system is essential to ensure the safety of patients, donors, and medical personnel, and to ensure that all aspects of the cell therapy process from product select to infusion are safe. Risk minimisation requires all personnel involved in cell therapy to be familiar with the procedures as well as cooperate with personnel from other disciplines. Staff training plays a key role in the implementation of cell therapy and in QM. New cell therapy applications are constantly being developed. Appropriate training of personnel will improve both the effectiveness of cell therapy and patient survival.
The management of risk and investment in cell therapy process development: a case study for neurodegenerative disease
