联系我们

论文查询结果	返回搜索

论文编号：	14098
作者编号：	2320200305
上传时间：	2023/6/9 9:19:36
中文题目：	A公司药品不良反应信息处理流程优化研究
英文题目：	Research on Individual Case Safety Reports Process Improvement for Company A
指导老师：	林润辉
中文关键字：	业务流程优化；机器人流程自动化；药品不良反应信息；药物警戒
英文关键字：	Business Process Optimization; Robot Process Automation; Individual Case Safety Reports; Pharmacovigilance
中文摘要：	随着中国在2017年加入国际人用药品注册技术协调会，即ICH (The In-ter-national Council for Harmonization of Technical Requirements for Pharma-ceuticals for Human Use)，这意味着我国对于药品的研发、生产和注册活动进入国际化标准的赛道上。目前在制药行业，最受关注的就是患者的用药安全问题，其重要性贯穿整个药品全生命周期。随着我国制药行业贸易全球化局面的打开，大大催化了药企积极开展药品创新、研发和上市活动，同时我国对药品安全的监管日趋加强，有关药物警戒的新政法规频出，尤其关注药品不良反应信息的监测和处理方面，相应给药企增加了不少工作量。我国在药物警戒体系建设起步较晚，相关法规对从业人员要求比较高，专业比较过硬的药物警戒人才数量稀缺，且人力成本也高。如何能在成本最优的情况下，加快且符合国家监管要求地处理好药品不良反应信息，成为各大药企的痛点。 本文以点带面，从其药品不良反应信息处理服务供应商的视角，运用案例分析法，针对医药企业A公司目前面临的药品不良反应信息处理工作量的上涨导致按时完成率表现变差，为此增加工作人员数量配备，又面临人力成本上涨的问题，提供解决方案。利用调查研究法，在对各种药品不良反应报告类型做可行性分析之后，选取可行性得分最高的来自监管部门的药品不良反应报告类型作为试点，结合基于业务流程优化理论、全面质量管理理论，对流程进行精益化处理，在此之后讨论流程自动化工具的机会点和应用流程自动化，最终整体实现流程优化。流程优化的目的在于确保A公司能够按时处理完成所要求药品不良反应信息报告量的前提下，同时能实现成本优化，从而满足国家药监局对药品安全信息快速处理及上报的要求，提高保护公众用药安全的能力。首先，本文通过对A公司药品不良反应信息处理流程的研究，利用全面质量管理理论，和文献分析法，从“人、机、料、法、环”角度去挖掘药企面临的外部和内部影响因素以及问题分析。其次，利用流程精益化管理理论，聚焦问题，测量每个环节并去除流程中的冗余步骤，同时发现实施流程自动化的机会点。从技术和业务层面分析“机器人流程自动化工具”参与药品不良反应信息处理的具体步骤的可行性，以及实施前后的成本效益对比分析。另外，也全面地考虑到了落地实施“机器人流程自动化工具”后“人机配合”场景下，在实际操作层面会发生完成时限问题和质量问题，并讨论了应对和改善方法。最后，针对引入“机器人流程自动化工具”方案的实施阶段，从组织结构、培训体系、流程管理、质量管理、供应商管理五个方面作为落脚提出行动方案，以及实施后的效果分析。确保药品不良反应信息处理的效能和柔性提升，从而满足按时完成率的要求，以及成本优化落实到位。
英文摘要：	As China joined the International Coordinating Council for the Registration of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017, this means that China's research and development, production, and registration activities for drugs have entered the track of international standards. Currently, in the pharma-ceutical industry, the most concerned issue is the safety of medication for patients, whose importance runs through the entire drug life cycle. With the opening up of the global trade situation in China's pharmaceutical industry, pharmaceutical companies have been greatly encouraged to actively carry out drug innovation, research and development, and marketing activities. At the same time, China's supervision of drug safety has been increasingly strengthened, and new policies and regulations related to drug vigilance have emerged frequently. Particular attention has been paid to the monitoring and processing of adverse drug reaction information, which has corre-spondingly increased a lot of workloads for pharmaceutical companies. In China, the construction of the pharmacovigilance system started relatively late, with relatively high requirements for practitioners in relevant regulations. The number of highly specialized pharmacovigilance talents is scarce, and the labor cost is also high. How to accelerate and comply with national regulatory requirements to handle adverse drug reaction information at the optimal cost has become a pain point for major pharmaceutical companies. From the perspective of its adverse drug reaction information processing service provider, this article uses a case study method to provide solutions to the problems of the decrease in on-time delivery rate and the increase in labor costs due to the in-creasing workload of adverse drug reaction information processing, which has led to an increase in the number of the related staffs. After conducting a feasibility analysis of various types of adverse drug reaction reports using the survey and research method, the type of adverse drug reaction report from the regulatory authorities with the highest feasibility score was selected as a pilot project. Based on business process optimization theory and comprehensive quality management theory, lean processing was carried out on the process, the opportunity points and application process auto-mation of process automation tools were discussed, and the overall process optimiza-tion was ultimately achieved. The purpose of process optimization is to ensure that Company A can process and complete the required amount of adverse drug reaction information on time, while also achieving cost optimization, in order to meet the re-quirements of the National Food and Drug Administration for rapid processing and reporting of drug safety information, and improve the ability to protect public drug safety. First of all, this article explores the external and internal influencing factors and problem analysis faced by pharmaceutical companies from the perspective of "human, machine, material, law, and environment" through research on the adverse drug reaction information processing process of Company A, using total quality management theory, and literature analysis. Secondly, using the theory of process lean management, focus on issues, measure each step and remove redundant steps in the process, while identifying opportunities for implementing process automation. Analyze the feasibility of "robotic process automation tool" participating in specific steps of adverse drug reaction information processing from the technical and business levels, as well as the cost-benefit comparison analysis before and after implementa-tion. In addition, it has also comprehensively considered that in the "man-machine cooperation" scenario after the implementation of the "robot process automation tool", there may be completion time limit issues and quality issues at the practical operation level, and discussed countermeasures and improvement methods. Finally, for the implementation stage of the introduction of the "robotic process automation tool" scheme, action plans are proposed from five aspects: organizational structure, training system, process management, quality management, and supplier manage-ment, as well as the effect analysis after implementation. Ensure that the efficiency and flexibility of adverse drug reaction information processing are improved to meet on time delivery target, and cost optimization is implemented in place.
查看全文：	预览  下载(下载需要进行登录)