RESUMEN
Objective:To analyze and study the difficulties and countermeasures in the implementation of the Qualified Person(QP) system for stem cell clinical research, and share the experience of QP management practice in our hospital in order to promote and improve the construction of the QP management system in medical institutions.Methods:Comprehensive investigations were conducted to summarize and analyze the shortage of talents, unclear qualifications, unclear responsibilities, and lack of assessment standards in the QP system of medical institutions.Results:In view of the difficulties in the implementation of the current QP system, it is suggested to consider a combination of improving the system of laws and regulations, strengthening the top-level design of stem cell research institutions, clarifying the qualification threshold, refining QP responsibilities, continuing training and assessment system, establishing QP support system, etc.Conclusions:Medical institutions are responsible for stem cell clinical research, and the improvement of the QP system can promote the development of the cell industry in China.
RESUMEN
The professionalism view of qualified person and some reasonable proposals for the promotion of the professionalism are put forward. The necessity of the professionalization of qualified person and the effective measures of perfecting the professionalization are studied by the comparative analysis between home and abroad combined with the game model analysis. Under the current national conditions, qualified person are repositioned, and after learning the advanced experience of the EU, the registration system is strictly carried out, which can promote the professionalism of qualified person and make relevant measures in order to restrict the behavior of qualified person.