美国药品检查员培训框架对我国的启示

目的:参考美国药品检查员的培训框架,探讨我国职业化药品检查员的培训体系发展方向.方法:从检查工作量、培训方式与内容、分级体系等方面比对分析美国FDA药品检查员培训框架与我国现阶段培训体系的异同.结果:我国药监培训部门需要从培训制度的法治化要求、检查员分级培训以及职业化药品检查员应该具备的能力与知识储备等方面完善我国职业...

The Enlightenment of the Training Framework of Drug Inspectors in the United States to China

Objective:To discuss the development direction of the training system in China by referring to the training framework of American drug inspectors.Methods:The similarities and differences between the US FDA drug inspector training framework and China training system in terms of inspection workload,training methods and content,and grading system were compared and analyzed.Results:China drug regulatory training department should improve China professional drug inspector training system in terms of the legal requirements of the training system,the graded training of inspectors,and the capabilities and knowledge reserves that professional drug inspectors should have.Conclusion:The construction of the training system for drug inspectors at all levels must be standardized under the leadership or guidance of the National Medical Products Administration.After the establishment of a complete professional drug inspector system,the relevant capabilities and levels of the drug inspector team in China will be gradually improved,and the specialization of the inspector team will be greatly improved.