[summit person] Li Junde: improvement of R & D data integrity management under the new registration policy

Mr Li Junde, a senior engineer, has been engaged in the research and management of new drugs for 25 years since he graduated from Hebei Medical University He has successively served as the director of the analysis department of Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd and the manager of the R & D center of Shijiazhuang No.4 Pharmaceutical Co., Ltd., and now he is the deputy director of the R & D center of North China Pharmaceutical Co., Ltd and the deputy director of the marketing management department Li Gong has rich experience in research of chemical generic drugs and technical requirements of laws and regulations He has successively won the titles of excellent inventor of Hebei Province, innovation talent of science and technology-based small and medium-sized enterprises in Hebei Province in 2016, and is also a special expert of China Pharmaceutical Quality Management Association On September 8-10, the 2017 China Pharmaceutical Summit Forum and the list of top 100 pharmaceutical enterprises in R & D strength jointly sponsored by yaozhi.com and China Pharmacy magazine was held in Chongqing We are honored to invite Mr Li Junde as a special guest of this conference to share his valuable research results and work experience with you Li Junde, deputy director of North China Pharmaceutical R & D center, professor level senior engineer, gave a speech on the report outline: 1 Analysis of common data integrity problems in various inspections; 2 Standardization of data integrity management in the R & D process; 3 Discussion on how to improve the level of data integrity management Data integrity has always been a long-term concern of the pharmaceutical industry at home and abroad With the exposure of a large number of data related events, the introduction of a series of new policies, regulations and guidelines for domestic pharmaceutical registration, and the formal accession of CFDA to ICH to truly integrate into the international drug regulatory system, the domestic requirements for data integrity will be further improved So what are the common data integrity problems in various inspections? How to standardize the management of data integrity in the R & D process? How to improve data integrity management? These are urgent issues for pharmaceutical companies In this speech, Mr Li Gong will answer questions and solve questions for you around these three questions Under the promotion of the new domestic policy, the inspection of the pharmaceutical industry is becoming more and more strict Every time we check the integrity of the relevant data is worth learning Through the analysis and discussion of the problems that have occurred, enterprises can see their own advantages and disadvantages and look back on their own problems, so as to effectively and pertinently improve and prevent the unexpected There are rules to follow, work according to the rules, and record the integrity of data, which requires data governance within the entire data life cycle, and data integrity in the process of pharmaceutical production and research and development GMP once said: write what you do (there are rules to follow), do what you write (do according to the rules), and record what you do (there are records to check) These three summaries are the basic guarantee of data integrity In any case, this is the basic principle to be maintained Accurate positioning, method oriented, and optimized management data integrity cover the internal environment, quality system, management culture and many other contents of pharmaceutical enterprises and departments Therefore, data integrity assurance needs to be able to accurately determine the direction, and can cover all the key and difficult contents in daily management Then have a complete, lean and effective method to guide, and strive to be ready for daily management and control.