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| 加入PIC/S对我国职业化专业化药品检查员队伍建设的思考 |
| Reflection on the Construction of China’s professional and specialized Team of drug inspector by Joining PIC/S |
| 投稿时间：2024-01-16 修订日期：2024-07-19 |
| DOI： |
| 中文关键词: 药品检查合作计划 职业化专业化 药品检查员 队伍建设 思考 |
| 英文关键词: PIC/S professional and specialized drug inspector construction Reflection |
| 基金项目: |
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| 中文摘要: |
| 目的：对我国职业化专业化药品检查员队伍建设进行深入思考，以期为早日加入PIC/S国际组织，实现我国药品检查国际化，促进我国医药行业走向世界提供参考与借鉴。方法：对照PIC/S审计清单中对检查员要求的模块，概述PIC/S对检查员的要求，对我国检查员队伍现状进行分析，对我国职业化专业化药品检查员队伍建设进行深入思考。结果与结论：加快建立职业化专业化药品检查员队伍，以满足PIC/S对药品检查员的要求。我们应该扩大职业化专职化检查员的规模，深入推进检查员的分级分类管理。同时，我们还需要建立高素质的检查员培养模式，以提升他们的检查能力。此外，我们还应建立具有职业特点的职称评审体系，并完善检查员的薪酬待遇保障机制和激励机制，以充分调动检查员提升能力的积极性和主动性。这些举措将为我国早日加入PIC/S提供坚实保证。 |
| 英文摘要: |
| Objective: Deeply consider the construction of a professional and specialized team of drug inspectors in China, in order to provide reference and inspiration for joining the PIC/S international organization as soon as possible, realizing the internationalization of drug inspection in China, and promoting the internationalization of China's pharmaceutical industry.Method: By comparing the PIC/S audit checklist, summarize the requirements of PIC/S for inspectors, benchmark the modules required by PIC/S for inspectors, analyze the current situation of the Professional Inspector team in China, and deeply consider the construction of a professional and specialized drug inspector team in China. Results and Conclusion: Accelerate the establishment of a professional and specialized team of drug inspectors to meet the requirements of PIC/S. We should expand the scale of professional and specialized inspectors and deepen the hierarchical and classified management of inspectors. At the same time, we also need to establish a high-quality inspector training model to enhance their inspection capabilities. In addition, we should establish a professional title evaluation system with professional characteristics, and improve the salary and incentive mechanism for inspectors to fully mobilize their enthusiasm and initiative to improve their abilities. These measures will provide a solid guarantee for China's early accession to PIC/S. |
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