Construction Of New Drug R&D Project Management Body Of Knowledge

A large extent,new drugs' R & D capability decides the competitiveness and sustainable development of enterprises.New drugs' R & D capability also decides whether China's pharmaceutical enterprises to occupy a favorable position in the international pharmaceutical market.In the globalize market,in the face of the competitors who have enormous technical and financial advantages,besides learning advanced technology actively and increasing the investment in R & D,China's pharmaceutical enterprises also should strengthen management to improve the level of new drugs' R & D and enhance the competitiveness.So,it requires the pharmaceutical companies using advanced methods to manage new drug R & D project, and improving new drugs' R & D levels by project management.In this paper,to improve the new drugs' R & D project management level and R & D capability of China's pharmaceutical enterprises is as the fundamental starting point.By literature search,field surveys,expert advice and case studies,the application of project management in China's pharmaceutical enterprises' new drug R & D has been studied systematically.On the basis,according to the Project Management Body of Knowledge Guide formulated by American Project Management Institute,the author set up a new drugs' R & D Project Management Body of Knowledge,and hope to use it in the guidance of new drug R & D project management.First,this paper has analyzed the new drugs' R & D situation and its developing trends at home and abroad,the problems in management of domestic pharmaceutical companies' new drugs' R & D project,given the key of the successful management in the new drugs' R & D project guiding.Based on the brief analysis above,in view of the different scales of enterprises,identified different strategies in the new drugs' R & D,which used for domestic pharmaceutical companies' information the new drugs' R & D project is the carrier of the company strategies' implementation,the organizational structure may limit the possibility of the new drugs' R & D project resource.It has great effort on the allotment and the lead of personnel.It comes up the organizational structure which is applicable to the new drugs' R & D project combined with pharmaceutical companies' practice.The new drugs' R & D project's stakeholders is another restraining factor,which will determine the new drugs' R & D project success or not,this paper has analyzed the new drugs' R & D project's stakeholders' importance in the new drugs' R & D.and how to treat these stakeholders to make sure the new drugs' R & D project will success.Secondly,the scope management,time management,cost control and quality management theory based on the PMBOK makes an in-depth research separately to the new drugs' R & D project's the scope management,time management,cost control and quality management. This article attempts to use the earned value method to do a system manage to the new drugs' R & D project's cost,progress and quality,in this way,to coordinate various targets of the project and control events of the project integrately.The human resources management,the communication management,procurement management,the risk management and the whole management theory based on the PMBOK, make a detailed analysis separately to the new drugs' R & D project's human resources management,the communication management,procurement management,the risk management and the whole management.Finally,the author combines the new drugs' R & D project's own characteristic,expands new drug R & D project management knowledge explorely,increased the new drugs' R & D innovation management,knowledge management,venture capital management and the intellectual property rights management four related areas of knowledge,and discusses the main content.