Research On Risk Management Of Shengmai Injection Project

The new drug research and development is a high investment, high technology content, high competition, high income activities. At present, China is still in the initial stage in the field of new drug research and development, this initial stage of the immaturity of a lot of resources supporting the incomplete nature of the new drug research and development projects have greatly increased the uncertainty, making the enterprise’s related risks greatly improved. As a new product, there are many uncertainties in the production of the injection project, although risk management can not ensure the success of the project investment, but it can prevent and reduce the impact of potential problems in the project. As a new R & D project, the project of the life and pulse injection is a new technology research and development and innovation. It has high risk. High R & D expenses, the uncertainties in the process of drug development, and the success rate of the drug in vivo, any risk factors may lead to the failure of this project. Once again, the timely development of the pulse injection project in time, but in the course of its follow-up, there may be a variety of clinical trials, will be a variety of clinical reactions. We all know that a lot of new drugs in the field of research and development success, but if the production of inputs used in the actual clinical process exist any adverse reactions, the State Food and Drug Administration will be stopped, so the development of the pulse injection project, the process is full of challenges. Therefore, the systematic study of the risk management of the project, the project will have a very positive effect on the actual progress of the project.This paper summarizes and combs the related theory of project risk management, taking the project of the injection of the project as an example, the risk identification, evaluation and control problem is studied. And from the perspective of risk management theory, this new drug research project implementation process of technical risk, production risk, market risk, financial risk, a detailed and in-depth analysis, and finally targeted to propose feasible risk prevention and control measures.The research of this paper is divided into seven parts:the first chapter is introduction. Around the subject of the research, the conditions of the study, the significance of the research, the main point of the study, set up the need to solve the problem, this paper discusses the domestic and foreign research situation, and finally established the research direction and objectives, the research methods and measures, the scope and content of the research, and summarized the innovation of this subject and the shortcomings of the research. The second chapter is about the theory of project risk risk. The basic theory of project risk identification and control is described in detail, including the definition, process and method. The third chapter is about the introduction of the project. Mainly including R & D Enterprises-S company’s basic operations, as well as the basis of the project of life and pulse injection, technical conditions and financing, etc.. The fourth chapter is the risk identification of the project (two development) of the injection of the life and the pulse injection. Through the comprehensive analysis of the basic risk factors of the project, the main risk of the new drug research project implementation process is determined, including:technical risk, production risk, market risk, financial risk. The fifth chapter is about the risk assessment of the project (two development) of the injection of the injection of the pulse. Based on the determination of the basic ideas of risk assessment, using the analytic hierarchy process AHP to construct the relevant index model, the above four major risk factors were integrated assessment and analysis. Prevention and control of risk in sixth chapter of the project (two R & D) of the pulse injection project. From the perspective of risk management theory, the technology risk, production risk, market risk, financial risk in the process of the implementation of the new drug research project are put forward. Seventh chapter conclusion part. This paper provides a comprehensive and detailed description of the basic points of this paper and the final conclusion, the experience of new drug research projects to provide a specific solution to the risk management problems and treatment advice, and also summarizes the shortcomings and deficiencies in the research process.