CK所新药研发项目的风险与进度管理

发布时间：2018-05-15 23:42

本文选题：项目管理 + 新药研发　；参考：《电子科技大学》2013年硕士论文

【摘要】：现代生物医药产业的快速发展对企业的资金、管理等提出了更高的要求。随着各大药企研发力度的不断加大，与研发相配套的项目管理水平也应不断提高，这样才能在能保证药企在做研发项目时，提高效率和成功率，并相应缩短研发周期，降低研发风险。本篇论文即通过分析CK所新药研发项目管理中存在的项目组织管理结构问题、风险管理问题，以及进度管理问题，提出在CK所的研发项目中引入科学项目管理的方法以改进和解决以上问题。论文的主要内容为：为CK所构建了更适合项目管理的平衡矩阵式项目组织管理模式，通过在项目团队中加入项目助理，改进了项目的沟通问题和进度管理问题，通过加入情报团队，加强了立项调研，降低了项目的立项风险；本文从技术风险、费用风险，管理风险、政策风险、知识产权风险、生产风险、市场风险等7个方面分析了本所新药研发项目可能会遇到的风险因素，对每个风险进行详细阐述，并提出相应的应对策略，以便于在项目研发过程中降低风险，并为CK所以后系统化项目风险管理的开展打下基础；本文还将工作分解结构（WBS）、关键路径法、项目甘特图、项目网络图（AON图）等工具和技术应用到本所的新药研发项目中，研究了在CK所实施项目进度管理的必要性和可能性，探讨了本所新药研发项目如何在有限的时间和资源限制下，提高工作效率、降低费用、缩短单个项目的研发周期并成功完成新药申报，最后本文还采用回顾性研究的方法，结合CK所一个研发项目的成功案例，将科学项目进度管理的方法应用到该项目中。总之，本文通过项目管理体系在新药研发项目管理上的应用，使本所新药研发项目的管理水平得以提升，，提高本所研发的效率，并降低了风险，使CK所在医药研发领域更具竞争力。
[Abstract]:The rapid development of modern biopharmaceutical industry has put forward higher requirements to the capital and management of enterprises. As the R & D efforts of the major pharmaceutical enterprises continue to increase, the level of project management associated with R & D should also be continuously improved, so that the efficiency and success rate can be improved and the R & D cycle can be shortened accordingly in order to ensure that the pharmaceutical enterprises are doing R & D projects. Reduce R & D risk. This paper analyzes the problems of project organization and management, risk management and schedule management in the management of new drug research and development project in CK Institute. In order to improve and solve the above problems, this paper puts forward the method of introducing scientific project management into the R & D project of CK Institute. The main contents of this paper are as follows: a balanced matrix project management model is constructed for CK, which is more suitable for project management. By adding a project assistant to the project team, the communication and schedule management problems of the project are improved. By joining the intelligence team, the research on project establishment has been strengthened, and the project risk has been reduced. In this paper, the risks of technology, cost, management, policy, intellectual property, production, etc. This paper analyzes the risk factors that may be encountered in the new drug R & D project of the Institute from seven aspects such as market risk, expounds each risk in detail, and puts forward corresponding countermeasures in order to reduce the risk in the process of project research and development. And lay the foundation for the risk management of post-systematization project of CK, and apply the tools and technologies such as work breakdown structure, critical path method, project Gantt diagram, project network diagram to the new drug R & D project of our institute. This paper studies the necessity and possibility of the project schedule management in CK, and discusses how to improve the working efficiency and reduce the cost of the new drug R & D project in the institute under the limited time and resources. The research cycle of a single project is shortened and the new drug application is successfully completed. Finally, the method of scientific project schedule management is applied to the project by using the method of retrospective research and combining with the successful case of a R & D project in CK. In a word, through the application of the project management system in the project management of new drug research and development, the management level of the new drug research and development project of the institute can be improved, the efficiency of the research and development of the institute can be improved, and the risk can be reduced. To make CK in the field of pharmaceutical research and development more competitive.
【学位授予单位】：电子科技大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F426.72;R954

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