"China cardiovascular disease clinical research quality management standard (GCP) conference" held successfully

Source: China Council for the promotion of medicine 2016-07-17 July 16-17, 2016 "China Association for the promotion of pharmaceutical innovation, China cardiovascular health alliance, China Pharmaceutical Society Clinical Medicine Professional Committee jointly sponsored the" China clinical research quality management standard (GCP) conference ", which was held in Suzhou, a beautiful Suzhou city The opening ceremony of the conference was presided over by song Ruilin, executive chairman of China Association for the promotion of pharmaceutical innovation The guests attending the conference were Wang Lifeng, director of the pharmaceutical registration department of the State Food and drug administration; Li Jianming, deputy director of the drug audit and inspection center of the State Food and drug administration; Shi Xinli, director of the second evaluation office of the medical device evaluation center of the State Food and drug administration; and Shi Xinli, director of Suzhou Huang Haitao, deputy director of the Management Committee of the industrial park; Jiang Hualiang, President of the China pharmaceutical innovation promotion association; GE Junbo, chairman of the cardiovascular branch of the Chinese Medical Association and chairman of the China Cardiovascular Health Alliance; huoyong, vice chairman of the China Cardiovascular Health Alliance; Han Yaling, chairman designate of the cardiovascular branch of the Chinese Medical Association; national medicine of the first hospital of Peking University Professor Cui Yimin, deputy director and office director of clinical trial organization, and many experts in cardiovascular field, experts in clinical trial organization, clinical research directors of pharmaceutical enterprises, heads of contract research organization (CRO) and doctors in clinical research line attended the opening ceremony of the conference As the first GCP conference focusing on cardiovascular field, there are so many stars in this scale, which is unprecedented! Since the inspection and verification of drug clinical trial data started by CFDA on July 22 last year, there has been a strong vibration in the pharmaceutical industry Now, the aftershock has not stopped According to the statistics of insight database as of June 21, 73.55% of 1622 varieties requiring self-examination have chosen to withdraw voluntarily (including 876 publicly withdrawn and 317 not publicly withdrawn), which is undoubtedly a time Major reform, an important opportunity! For the field of cardiovascular, whether clinical diagnosis and treatment or clinical research management in the field of cardiovascular will be a historic opportunity, which will promote the standardization of clinical research quality management in China and accelerate the integration of clinical research in the field of cardiovascular and international Through this "China cardiovascular disease clinical research quality management standard (GCP) conference", we will explore a new way of thinking that is in line with national conditions and in line with international standards, which will bring opportunities for the development of cardiovascular field in China and benefit more cardiovascular patients The two-day conference was successfully held under the careful organization of all parties There were national CFDA leaders' interpretation of national policies, professional cardiovascular GCP training, and special forums on "clinical research of cardiovascular drugs" and "clinical research of cardiovascular devices" For the first time, we really invited national regulatory agencies, research institutions, bidding agencies and contract research organizations to come together for in-depth discussion in the form of multi-party participation Based on the quality management standards of cardiovascular clinical research in China, we will promote research institutions to share and learn valuable experience of clinical research and management at home and abroad, and jointly improve the quality management system of clinical research and the research and development ecological environment in China It is expected that more clinical trial applicants and researchers will really pay attention to and ensure the authenticity, integrity and standardization of clinical data, while regulators will be able to formulate more scientific, reasonable and efficient measures to promote the level of clinical trial research and evaluation technology system in China to be in line with the international standards, promote the healthy development of the pharmaceutical industry, ensure the safety of public drug use, and finally innovate and research for Chinese drugs To create a healthy and sustainable environment and unremitting efforts! Song Ruilin, executive chairman of China Association for the promotion of pharmaceutical innovation, Jiang Hualiang, chairman of China Association for the promotion of pharmaceutical innovation, Huang Haitao, deputy director of Suzhou Industrial Park Management Committee, academician Ge Junbo, chairman of China Association for cardiovascular health, Wang Lifeng, director of the pharmaceutical registration department of state food and Drug Administration Li Jianming, deputy director of the drug audit and inspection center of the State Food and drug administration, and Cui Yimin, deputy director of the national drug clinical trial organization and director of the office of the first hospital of Peking University