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| 美国药品检查员培训框架对我国的启示 |
| The Enlightenment of the Training Framework of Drug Inspectors in the United States to China |
| 投稿时间：2020-10-27 修订日期：2020-12-22 |
| DOI： |
| 中文关键词: 药品 药品检查员 培训 职业化检查员 |
| 英文关键词: Drug Drug Inspectors Train Professional Inspectors |
| 基金项目:国家重点研发计划项目“食品安全突发事件及重大事件应急指挥决策技术研究”；项目编号：2018YFC1603704 |
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| 中文摘要: |
| 摘要：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化药品检查员培训体系。结论 各级药品检查员培训体系建设必须在国家局的领导或指导下统一标准，建立起完善的职业化药品检查员体系后，我国的药品检查员队伍的相关能力和水平会逐步提升，检查队伍的专业化问题将会大大改善。 |
| 英文摘要: |
| ABSTRACT: OBJECTIVE Refer to the training framework of American drug inspectors to discuss the development direction of the training system in China. METHODS Compare and analyze 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. RESULTS China drug regulatory training department needs to 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 establishing of a complete professional drug inspector system, the relevant capabilities and levels of the drug inspector team in China will gradually improve, and the problem of inspector team specialization will be greatly improved. |
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