Research On Risk Management Of New Product Development In XB Pharmaceutical Company

The pharmaceutical industry can play a vital role in safeguarding people’s lives and health.At the same time,the pharmaceutical industry is also a high-tech,high-risk,high-yield area.Since the reform and opening up,China has vigorously promoted the reform of science and technology system and economic system in the field of pharmaceutical industry,which has led to the all-round development of the pharmaceutical industry.At present,the pharmaceutical industry already has a relatively complete pharmaceutical industry system.The pharmaceutical industry has also become one of the pillar industries of national economic development.Among them,new drugs are the most popular objects,and they are also the foundation for survival for pharmaceutical companies.New drugs can enter the market quickly,which means that pharmaceutical companies have the advantage of taking the lead in the market.However,there are many problems in the domestic pharmaceutical industry,such as numerous enterprises,high cost,small scale,and low efficiency.At the same time,new drug research and development is also facing various risks.In the development of new drugs,how to effectively carry out risk management and control has become the key to success.In general,the risk management of new drug development includes risk identification,risk assessment,risk quantification,etc.,and then effectively controls,monitors,and plans the risks of the relationship,minimizes risks,responds to risks,and improves R&D success rate.This article takes XB company as an example to study the company’s pharmaceutical R&D risk management and control.The paper summarizes the definition,characteristics and classification of risks,and the risk management theory of new drug development,which lays a solid theoretical foundation for the following research.The current situation of new product research and development in XB pharmaceutical company,as well as the new product development characteristics of XB Pharmaceutical company,were analyzed,and a preliminary understanding of the overall situation of XB Pharmaceutical company was obtained.Focus on the identification of new product development risks of XB Pharmaceutical company,including risk identification of project establishment link,risk identification of preclinical research links,risk identification of clinical trial links,risk identification of production links,risk identification of listing and post-listing monitoring links,etc.A risk assessment was conducted for the development of new products in XB Pharmaceutical company.On this basis,the risk control measures and suggestions of new product development in XB pharmaceutical company were put forward,and the specific risk control strategies of new product development of XB pharmaceutical company were proposed in combination with different research and development stages and different types of risks.Suggestions for improving the risk control system of new drug R&D in XB pharmaceutical company,including the establishment of a sound scientific project decision-making system,effective R&D management and schedule control system,effective fund guarantee system,project research and development system suitable for the company’s own strength,effective personnel incentive mechanism system,and safety monitoring after new drug launch Network system,etc.,hope to have a certain reference to the new product development of XB Pharmaceutical company and the risk management of other pharmaceutical companies.