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论文编号：	13466
作者编号：	2320200572
上传时间：	2022/12/3 12:55:34
中文题目：	L公司基于关键链的新药研发IND阶段项目进度管理研究
英文题目：	Research on the Project Schedule Management of New Drug R&D IND Stage of L Company Base on the CCPM
指导老师：	焦媛媛
中文关键字：	L公司；新药研发项目；进度管理；IND；关键链
英文关键字：	L Company；New Drug R&D projects；Schedule management；IND；CCPM
中文摘要：	自2017年药品上市许可持有人制度第一次在国内正式出现后，新的《药品管理法》和《药品注册管理办法》陆续发布，有效的提高了新药的研发、审评、生产和上市等环节的效率。仅2021年上半年，我国已批准21个创新药，新药数量已大于2020年全年批准数量，2021年全年审评通过47个创新药，创历史新高，我国新药的研发逐渐步入了国际轨道。新药研发过程是一个项目管理的过程，新药的研发进度是新药研发的重中之重。一个新药是否能如期完成研制、申报、批准和上市，不仅仅关系到新药品的市场价值，同样关系到广大人民生命质量。因此，项目进度管理研究对一个制药企业的持续长远发展，提升市场竞争力具有重要的意义。 本文以L公司新药研发IND（Investigational New Drug,新药临床试验申请）阶段项目为研究对象，使用项目进度管理理论，将项目进度计划和项目进度控制的方法应用于L公司新药研发IND阶段项目中。在研究过程中，对于L公司新药研发IND阶段项目中出现的项目进度计划制定不合理，项目进度控制不完善等问题进行分析总结，使用关键链技术对新药研发IND阶段项目的工作进行分解、排序并确定项目工期，采用减半法消除过剩的安全时间，并使用适用新药研发IND阶段项目的改进根方差法计算和设置缓冲时间。在项目实际实施过程中，使用缓冲期的动态预警对项目进行控制。同时分析影响进度控制因素，采用项目组织保障、风险管理保障和制度保障等措施保障项目的按期完成。 本文以L公司M项目为例，采用上述关键链技术对L公司新药研发IND阶段项目进度进行管理后，消除了L公司新药研发IND阶段项目过剩的安全时间，缩短了新药研发IND阶段的研究工期，并确保了新药研发IND阶段项目按期完成。本文成功将关键链项目进度管理方法运用在新药研发IND阶段项目，不仅为本公司的新药研发IND阶段项目提供了有效的项目进度管理方法，也为本公司新药研发其他阶段项目和其他同行业企业新药研发项目进度管理存在的不足提供了方向。
英文摘要：	Since the first Marketing Authorization Holder System issued in China in 2017, The new Pharmaceutical Administration Law and Provisions of Drug Registration have been launched. This significantly improved the efficiency of R&D, review, production and marketing of new drugs. In the first half of 2021, 21 innovative drugs have been approved in China, and the number of new drugs has exceeded the ones in whole year of 2020. In 2021, 47 innovative drugs were approved, which is keeping up with the international pace. New drug R&D process is a project management process, and new drug R&D schedule is given high priority of new drug R&D. Whether a new drug can complete the development, declaration, approval and listing on schedule is not only related to the market value of new drugs, but also related to social healthcare. Therefore, the research on project schedule management is important to the sustainability and long-term development of a pharmaceutical enterprise and to enhance its ability of market competition. This thesis takes the new drug R&D IND phase project of L company as the research object, using the project schedule management theory, applying the method of schedule and schedule control to the new drug R&D IND phase project of L company. During the research process, the problems such as unreasonable project schedule planning and imperfect project schedule control in the IND phase project of new drug research and development of L company were analyzed and summarized. The Critical Chain Project Management (CCPM) was used to decompose and sort the work of the IND phase project of new drug R&D and determine the project duration. The halving method was used to eliminate the excess safety time, and the Root Square Error Method suitable for the improvement of the IND phase project of new drug research and development was used to calculate and set the buffer. In the actual implementation of the project, the buffer period of dynamic early warning is used to control the project. At the same time, it analyzes the factors affecting progress control, and adopts measures such as project organization, risk management and system policy to ensure the completion of the project on schedule. This thesis takes L company M project progress management as an example. After using the above-mentioned CCPM to manage the project progress of L company's new drug development IND phase, the excess safety time of L company's new drug development IND phase project is eliminated, and the time for new drug development IND phase is shortened. And ensured that the IND phase of new drug R&D projects were completed on schedule. This thesis successfully applied the CCPM method to the IND stage project of new drug R&D, which not only provided an effective project progress management method for the company's new drug R&D IND stage project, but also provided direction for the deficiencies of project schedule management in other stages projects of Company L and new drugs of enterprises in the same industry.
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