The annual meeting of dia was opened in Shanghai, directly attacking the changes brought about by the innovation of Chinese drug R & D and laws and regulations

Source: bioprospecting 2017-05-23 on May 22, 2017, the "2017 China International Drug Information Conference and the 9th dia China Annual Conference" opened in Shanghai International Conference Center The theme of this annual meeting is "abide by the clinical value orientation, lead the new trend of drug research and development", return to the essence of drug research and development of "clinical value", consolidate the foundation of new drug research and development, promote high-quality new drug development, and effectively meet the needs of patients The conference attracted more than 2000 participants from all continents and regions in drug administration, drug research and development, and health industry, and more than 100 booths for image display, directly attacking the changes brought about by Chinese drug research and development and regulatory innovation Since 2009, the drug information association (DIA) has successfully held 9 annual conferences in China in cooperation with China food and drug International Exchange Center, which is the only neutral international exchange platform dedicated to the dissemination of drug information knowledge in China In this year's dia, 13 special topics were set up, including hot topics such as "regulatory science with both opportunities and challenges", "key points and hot spots of tumor drug development", "quantitative science in transformation" and "strategy and tactics for early development of innovative drugs" In order to adapt to the change, the conference also launched two innovative exhibition forms, namely "Diamond Classic branch seminar" and "innovation port Exhibition" suitable for small and medium-sized new-type R & D enterprises 1 opening ceremony: May 22 is the first day and official opening day of 2017 China International Drug Information Conference and the 9th dia China Annual Conference At 1:30 p.m., Zhu Lihong, general manager of dia China, thanked all the guests on behalf of dia Later, Ms Barbara Lopez Kunz, Global CEO of DIA, Xu Ning, executive vice president of zaiding pharmaceutical, CO chairman of the conference, and Xue bin, director of China food and drug International Exchange Center delivered speeches successively In his speech, director Yuan Lin of the Department of international cooperation of the State Food and Drug Administration positively affirmed the work of dia in the field of drug research and development This annual meeting of dia is themed by "adhering to the clinical value orientation and leading the new trend of drug research and development", and a series of academic discussions and CFDA encouraged innovation and promoting the supply system structure under the background of the reform of China's drug review and approval system The direction of the reform is fully in line, so as to better meet the public's drug demand and accelerate the construction of a healthy China 2 In May, CFDA, the Diamond Classic branch, issued four drafts for comments in the name of reform: the General Administration said in the announcement that the purpose of issuing the four drafts was "to further deepen the reform of the review and approval system, promote the structural adjustment and technological innovation of the pharmaceutical and medical device industry, improve the industrial competitiveness and meet the clinical needs of the public" The "draft for comments" will be open to the public for comments On the afternoon of May 23, as one of the special sessions of this year's Diamond Classic branch, CFDA will focus on the following main contents: 3 wonderful review: pre meeting on May 21 In accordance with the Convention, the sponsor held a pre conference Symposium on May 21, with five topics in total: the industrial upgrading of generic drugs under the new policy and new situation, the consideration of risk management in clinical trials, the verification of data flow, becoming the most statistical medical affairs expert, and the joint seminar of CFDA / dia on ICH Among the five symposiums that China has submitted for conditional admission to ICH, the most interesting one is the CFDA / dia Joint Seminar on ICH jointly organized by CFDA and dia Yuan Lin, director of CFDA's International Cooperation Department, reviewed CFDA's active participation in ICH activities in recent years, made great contributions to the formulation and revision of some international standards related to ICH, and actively transformed and referred to more than 20 ICH technical guidelines, becoming an important part of China's technical approval Through a series of reforms, CFDA promotes the listing of safer and more effective products to better meet the needs of the public He said that the time for China to join the ICH is basically ripe, and China has submitted an application to join the ICH conditionally The speakers and participants discussed the latest progress of the technical guidelines, CFDA's technical guidelines and implementation of ICH, the expectation of the pharmaceutical industry to join ICH, and the direction and Prospect of implementing ICH in China Participants said that under the global trend of innovation, China's participation in ich will speed up the research and development of innovative drugs, which will help new drugs to be applied in clinical practice faster and benefit patients The market of generic drugs will move closer to Europe and the United States At present, the market share of generic drugs in China's listed drugs is more than 95%, which is an important basis of the national basic medical security system The consistency evaluation of generic drugs implemented last year is a huge challenge for many pharmaceutical companies Therefore, the Symposium on generic drugs has attracted much attention Dr Li Yuannian, senior vice president of Jiangsu Haosen Pharmaceutical Co., Ltd., Dr Yang Jianhong from Yihong Business School of Shenyang Pharmaceutical University, Dr Liu Ping from Pfizer, Dr Lei Jifeng from abison pharmaceutical, Dr Daoyuan Xiaosi from Japan, Dr Dale Conner from FDA, Dr Alexander from the inspectors network consulting and training services, served as the chairman of the symposium A number of Chinese and foreign experts, such as hoel, Dr Yang Yongjian from Shanghai food and Drug Inspection Institute, Li Xuening from Fudan University School of pharmacy, and Dr Xie Yuli, who occasionally leads biomedicine in Suzhou, made speeches Risk management is needed in clinical trials The special discussion on "risk management is needed in clinical trials" is organized by Beijing people and Dr Zhao Zixian of mozxiaoyao of Guangtong and AstraZeneca This workshop discusses how to conduct risk management in the process of clinical research design and implementation The risk management in the implementation of clinical research includes the following aspects: known risk-based monitoring, evaluation, evaluation and mitigation measures, identification, evaluation and management of new safety signals, management of emergency safety events, and update of research program flow due to new risks in clinical trials Dr Chen Xiaoxiang and Dr Li Zhi, Dr Guo Xiang and Wei Fang of bringer Ingelheim jointly served as members of the Organizing Committee of the Symposium on "becoming the most statistical medical affairs expert" In the meeting, how to identify statistical deviation, hypothesis test, sample size estimation, etc in the statistical data will be shared, which will help the medical affairs personnel to find the deficiencies in the research design and correctly interpret the statistical problems in the medical literature Dr Sun Hualong, general manager of MEDA clinical data Technology Co., Ltd., is the chairman of this topic The quality and credibility of the database is the key to the success of clinical trials At present, there are still some deficiencies in database construction, programming and some data management processes The topic of data process verification shares the data management plan and how to apply data process management in different electronic data collection systems.