CK所新藥研發(fā)項目的風(fēng)險與進度管理
本文選題:項目管理 + 新藥研發(fā) ; 參考:《電子科技大學(xué)》2013年碩士論文
【摘要】:現(xiàn)代生物醫(yī)藥產(chǎn)業(yè)的快速發(fā)展對企業(yè)的資金、管理等提出了更高的要求。隨著各大藥企研發(fā)力度的不斷加大,與研發(fā)相配套的項目管理水平也應(yīng)不斷提高,這樣才能在能保證藥企在做研發(fā)項目時,提高效率和成功率,并相應(yīng)縮短研發(fā)周期,降低研發(fā)風(fēng)險。 本篇論文即通過分析CK所新藥研發(fā)項目管理中存在的項目組織管理結(jié)構(gòu)問題、風(fēng)險管理問題,以及進度管理問題,提出在CK所的研發(fā)項目中引入科學(xué)項目管理的方法以改進和解決以上問題。論文的主要內(nèi)容為:為CK所構(gòu)建了更適合項目管理的平衡矩陣式項目組織管理模式,通過在項目團隊中加入項目助理,改進了項目的溝通問題和進度管理問題,通過加入情報團隊,加強了立項調(diào)研,降低了項目的立項風(fēng)險;本文從技術(shù)風(fēng)險、費用風(fēng)險,管理風(fēng)險、政策風(fēng)險、知識產(chǎn)權(quán)風(fēng)險、生產(chǎn)風(fēng)險、市場風(fēng)險等7個方面分析了本所新藥研發(fā)項目可能會遇到的風(fēng)險因素,對每個風(fēng)險進行詳細(xì)闡述,并提出相應(yīng)的應(yīng)對策略,以便于在項目研發(fā)過程中降低風(fēng)險,并為CK所以后系統(tǒng)化項目風(fēng)險管理的開展打下基礎(chǔ);本文還將工作分解結(jié)構(gòu)(WBS)、關(guān)鍵路徑法、項目甘特圖、項目網(wǎng)絡(luò)圖(AON圖)等工具和技術(shù)應(yīng)用到本所的新藥研發(fā)項目中,研究了在CK所實施項目進度管理的必要性和可能性,探討了本所新藥研發(fā)項目如何在有限的時間和資源限制下,提高工作效率、降低費用、縮短單個項目的研發(fā)周期并成功完成新藥申報,最后本文還采用回顧性研究的方法,結(jié)合CK所一個研發(fā)項目的成功案例,將科學(xué)項目進度管理的方法應(yīng)用到該項目中。 總之,本文通過項目管理體系在新藥研發(fā)項目管理上的應(yīng)用,使本所新藥研發(fā)項目的管理水平得以提升,,提高本所研發(fā)的效率,并降低了風(fēng)險,使CK所在醫(yī)藥研發(fā)領(lǐng)域更具競爭力。
[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.
【學(xué)位授予單位】:電子科技大學(xué)
【學(xué)位級別】:碩士
【學(xué)位授予年份】:2013
【分類號】:F426.72;R954
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