Risk Management Of New Drug Research And Development Project

The R&D of new medicine is a costly and high-risk project which requires long time, high input and advanced scientific technology, therefore, the study of the risk management in new medicine R&D projects is necessary and significant.This paper aims to study the risk management in the new medicine R&D projects by taking view about the characteristics and status of the research. This paper briefs the research background ,purpose, direction and framework and reviews the current research level in this field first; then covers the concept and some related theories of Project, Risk,etc; lastly, the five process of risk management in new medicine R&D projects--risk identification, risk assessment, risk quantification and risk response is discussed.Three important conclusions are drawn in this paper. In risk identification, the paper refers to the life cycle of new medicine R&D, comprehensively and deeply identifies ten risk factors in the new medicine research process through Work Breakdown Structure and puts forward risk measures related. In risk quantification,the Analytic Hierarchy Process, which can be easily understood and mastered by the new medicine researchers is applied, and further verify which case analysis. In addition, the paper designs the risk management procedure in new medicine R&D projects, so as to enable the new medicine researchers to start risk management in the early stage of the R&D process, and provide a useful reference for the managers of new medicine R&D projects in the medicine enterprises and research institutions.