Research On Schedule Management Of In Vitro Diagnostic Reagent R&D Porject

With the rapid development of our economy and biological science research capability, in vitro diagnostic reagents in China industry has achieved rapid development, but also facing the enormous challenge of foreign enterprises have poured into the. How to survive and develop is an important task of our country in vitro diagnostic reagent of the enterprise in the fierce competition in the market, and improve the ability of research and development, R&D management ability is the effective way to promote the business continued to grow and develop in vitro diagnostic reagents in China, enhance the market competitiveness of the enterpriseIn this paper, combined with the author’s enterprise in practical problems appeared in the course of product development of diagnostic reagent of third kinds of in vitro, through the application of the research of project schedule management method, the main work is as follows:(1) The definition of third kinds of in vitro diagnostic reagent products R&D project scope, the establishment of product R&D project process, through summarizing the third types of in vitro diagnostic reagents development process characteristics, analysis of the causes of delay in project progress management, that influence the development progress of regulations, human resources, test, design, capital, materials, communication management and so on seven factors, and the influence on the research and development of the various stages of the process factors were identified, form factors identification of in vitro diagnostic reagents of R&D project schedule.(2) According to the third types of in vitro diagnostic reagent for each stage of R&D project schedule influence factors have their own characteristics, the project activities are divided into two categories:one category is the progress of less influence factors, schedule controlled project, product and strong declaration registration phase. Another kind is the progress of many influence factors, and evaluate clinical stage assessment schedule controlled development, weak product performance. Estimation methods for different stages of adopting different project activity duration. On the basis of the progress of the project planning, and puts forward the corresponding schedule control measures according to different types of schedule influence factors.(3) To verify the feasibility of project management of third kinds of in vitro diagnostic reagent method and validity. Through specific project examples of PIK3CA gene mutation detection kit developed and validated, effective classification of estimating the duration of the project, to take corresponding measures to control the schedule management of different stages of the project, make the project realize smoothly according to plan, and has obtained the good application effect. In order to solve the problem of third kinds of in vitro diagnostic schedule management of R&D project management provide reference reagent products.