美国药品监管人员培训模式分析及其对我国的启示

Analysis on Training Mode of FDA Personnel and Its Enlightenment on China

目的:为发展和完善我国药品监管人员培训制度提供建议。方法:介绍美国法规事务办公室大学的具体运作模式,分析中美两国药品监管人员培训模式的差别。结果与结论:美国药品监管人员培训现已建立了系统、连续、统一的体系,较之我国有一定的灵活性、先进性。我国可借鉴美国的相关经验,在我国药品监管人员培训统一性、预算机制以及培训方式多样化等方面作出相关改进。

OBJECTIVE：To provide suggestions for the development of training mode for pharmaceutical monitoring personnel in China.METHODS：The training mode of Office of Regulatory Affair University（ORA U） was introduced to analyze the difference of training mode for pharmaceutical monitoring personnel between China and America.RESULTS CONCLUSIONS：America has established a systematic,continuous and uniform pharmaceutical monitoring personnel training system,which is more flexible and advanced than that in China.Our country could draw experiences from the training mode of FDA personnel to develop uniform and diversified training system with suitable budget mechanism.