Pre-Clinical Project Management Of New Medicine Of TCM

Objective:The pharmaceutical industry is one of the pillar industries of all countries in the world.It is also an intellectually intensive industry supported by China.The low levels imitation R&D of New Medicine of TCM and the high quality and volume demand from the market's is one of the major contradictions in the current stage of China's pharmaceutical industry development.In the opportunities and challenges coexist environment of globalization market,its important that pay attention to the intellectual property rights in the innovation and then leads to changing in quality,so as to promote the healthy development of the pharmaceutical industry strategically.Based on the characteristics of wide range of knowledge areas,multi-disciplinary cooperation,high risk of technical process uncertainty,and high-risk and long-return investment cycles in the face of R&D of New Medicine of TCM projects and the lack of research in R&D management areas in domestic and the advanced and mature project management systems in the international circumstances,the author intends to analyze the management of R&D of New Medicine of TCM projects and take the company as the main research object to analyze the management problems in the development of TCM for new drugs.And try to put forward preliminary proposals for the application of the project management knowledge system to the R&D phase before clinical trials of new medicines.Finally,summarize the organizational process assets within a limited scope of application to providing experience for later practitioners.Methods:The thesis clarifying the feasibility of research by uses literature research and investigation methods to study the pre-clinical R&D status of New Medicine of TCM in domestic and foreign pharmaceutical companies and the development status of project management knowledge systems from different perspectives and approaches;Clearly the main study directions through consulting with relevant experts by obtain the main problems,opinions and experiences existing in the current R&D process;Based on the above study and use the field research method,we have tailored the A Guide to the Project Management Body of Knowledge(PMBOK? Guide)-fifth Edition from the Project Management Institute to applied the key theories and methods that were rationally used to the pre-clinical research management of New Medicine of TCM,and observed andsummarized the results.Results: The study analyzes the characteristics of the pre-clinical projects of new TCM and the status of project management application in the R&D process.Then proposed the unscientific and rigorous problems existing in project decision-making;the weak control situation of the project research progress;the insufficient communication between project stakeholders;and the unstandardized and incomplete documentation of R&D projects.Finally,it proposes pre-clinical research guidelines and management procedures for New Medicine of TCM;project schedule management process and the earned value management method for monitoring and forecasting project progress;proposes communication management plans through analysis of R&D organizational structure and stakeholders;and propose organizational process assets management proposals for R&D project.Conclusion : It will become a trend that the application of project management knowledge and technology in the R&D process of New Medicine of TCM in the future pharmaceutical industry.This article explores the combination of the project management knowledge system and the pre-clinical R&D process of New Medicine of TCM.How to adapt to the trend of the normalization advanced technologies in the development of new drugs will become a new issue.Project management theory and technology will play a crucial role in this circumstance.At present,the management of new drug R&D projects still needs to be improved,and new theories,methods,and technologies need to be continuously studied.Adaptability improvement should be carried out after insufficient are founded in the practical.How to control the project from a whole perspective,and adjustment of project details in precise in order to achieve the goal of control risks and the project objectives.