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snqing木蟲(chóng) (正式寫(xiě)手)
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[求助]
摘要-中文翻譯成英文(請(qǐng)勿用機(jī)器翻)
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新藥研發(fā)由于其高風(fēng)險(xiǎn)、高投入、長(zhǎng)周期,以及涉及學(xué)科領(lǐng)域廣泛,需要特別研究資質(zhì)等特點(diǎn),從成本和資源上考慮,需要制藥企業(yè)、新藥研發(fā)企業(yè)以及科研院所之間進(jìn)行合作研發(fā)。新藥合作研發(fā)是一個(gè)非常復(fù)雜的過(guò)程,要與合作單位共同進(jìn)行小試、中試、臨床試驗(yàn)、注冊(cè)申報(bào)后才能上市銷(xiāo)售。開(kāi)展新藥合作研發(fā)項(xiàng)目進(jìn)度管理研究,以加快新藥研發(fā)速度,縮短新藥研發(fā)周期,提高研發(fā)效率,已經(jīng)成為企業(yè)必須開(kāi)展的一項(xiàng)重要工作。 本文以新藥NMF的研發(fā)項(xiàng)目為例,對(duì)新藥的合作研發(fā)項(xiàng)目在項(xiàng)目進(jìn)度計(jì)劃制定和進(jìn)度控制方面進(jìn)行了研究。首先,在對(duì)國(guó)內(nèi)外項(xiàng)目進(jìn)度管理研究現(xiàn)狀和相關(guān)理論進(jìn)行簡(jiǎn)要分析的基礎(chǔ)上,對(duì)NMF新藥項(xiàng)目的運(yùn)作體系進(jìn)行了論述,分析了影響項(xiàng)目研發(fā)進(jìn)度的主要因素,對(duì)項(xiàng)目的組織機(jī)構(gòu)、項(xiàng)目研發(fā)流程和運(yùn)作體系等進(jìn)行了介紹。其次,利用進(jìn)度管理相關(guān)理論和方法對(duì)項(xiàng)目的進(jìn)度計(jì)劃制定進(jìn)行了研究,在對(duì)網(wǎng)絡(luò)計(jì)劃技術(shù)進(jìn)行充分了解的基礎(chǔ)上,分析了新藥項(xiàng)目研發(fā)流程,利用工作分解結(jié)構(gòu),CPM法、Microsoft Project軟件等方法和工具制定了項(xiàng)目的進(jìn)度計(jì)劃。第三,介紹了在項(xiàng)目進(jìn)度控制方面所采取的措施和方法,采用進(jìn)度動(dòng)態(tài)跟蹤與控制的方法解決項(xiàng)目在實(shí)施過(guò)程中產(chǎn)生的進(jìn)度問(wèn)題,并通過(guò)對(duì)進(jìn)度計(jì)劃的及時(shí)更新,確保項(xiàng)目總進(jìn)度不受影響。最后,在此項(xiàng)目的基礎(chǔ)上,對(duì)新藥合作研發(fā)過(guò)程主要影響因素進(jìn)行了分析,總結(jié)了在本項(xiàng)目進(jìn)度管理和控制方面的經(jīng)驗(yàn),提出了改進(jìn)意見(jiàn)和建議。 |
鐵桿木蟲(chóng) (正式寫(xiě)手)
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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. 非機(jī)器翻譯,僅供參考 |

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