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新药研发由于其高风险、高投入、长周期，以及涉及学科领域广泛，需要特别研究资质等特点，从成本和资源上考虑，需要制药企业、新药研发企业以及科研院所之间进行合作研发。新药合作研发是一个非常复杂的过程，要与合作单位共同进行小试、中试、临床试验、注册申报后才能上市销售。开展新药合作研发项目进度管理研究，以加快新药研发速度，缩短新药研发周期，提高研发效率，已经成为企业必须开展的一项重要工作。 本文以新药NMF的研发项目为例，对新药的合作研发项目在项目进度计划制定和进度控制方面进行了研究。首先，在对国内外项目进度管理研究现状和相关理论进行简要分析的基础上，对NMF新药项目的运作体系进行了论述，分析了影响项目研发进度的主要因素，对项目的组织机构、项目研发流程和运作体系等进行了介绍。其次，利用进度管理相关理论和方法对项目的进度计划制定进行了研究，在对网络计划技术进行充分了解的基础上，分析了新药项目研发流程，利用工作分解结构，CPM法、Microsoft Project软件等方法和工具制定了项目的进度计划。第三，介绍了在项目进度控制方面所采取的措施和方法，采用进度动态跟踪与控制的方法解决项目在实施过程中产生的进度问题，并通过对进度计划的及时更新，确保项目总进度不受影响。最后，在此项目的基础上，对新药合作研发过程主要影响因素进行了分析，总结了在本项目进度管理和控制方面的经验，提出了改进意见和建议。 |
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befair
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爱与雨下: 金币+1 2013-12-27 22:44:44
snqing: 金币+100, 翻译EPI+1, ★★★很有帮助, 还行，就是长句子有点儿多 2013-12-28 18:19:05
爱与雨下: 金币+1 2013-12-27 22:44:44
snqing: 金币+100, 翻译EPI+1, ★★★很有帮助, 还行，就是长句子有点儿多 2013-12-28 18:19:05
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Development of new drugs is characterized by high risk, high investment and long cycle times and involves multiple disciplines. In addition, it requires special research qualifications. Therefore, considering the cost and resources, a collaborative research and development between drug manufacturers, new drug development companies and research institutions is required. This new drug research and development is a very complicated process in which the partners must jointly carry through lab test, pilot test, clinical test and drug registration application before the drugs can be launched for sale. To carry out research on progress management in collaborative development projects for new drugs such that new drug development is sped up, development cycle times shortened and overall development efficiency enhanced, has become an important work for enterprises to do. This paper uses the development project for the new drug NMF as example and studies the project progress plans and progress controls in collaborative development projects for new drugs. To start with, based on a brief review of the current research of project progress management in China and abroad and related theories, the operational framework for the NMF new drug project is described, the major factors influencing the project development progress are analysed and organisation structure, project development processes and operational framework are presented. Secondly, by means of theories and methods for progress management, how the project progress plan is set up, is researched. Based on a thorough understanding of network scheduling techniques, the new drug development project process is analysed. Using work breakdown structures, software and methods such as CPM and Microsoft Project are used to create the progress plan for the project. Next, measures and methods used for controlling project progress are described. With the method of progress dynamic tracking and control, problems with progress arising during project execution are solved. By prompt updates of the progress plan, the overall project progress is assured unaffected. Lastly, based on the project, the main influencing factors for new drug collaborative development are analysed, the experiences gained in progress management and control of the project summarized and comments and recommendations made for improvements. 非机器翻译，仅供参考 |
2楼2013-12-27 21:14:42