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    Home > Medical News > Medical World News > What are the gods-level figures of the Experts outside the CDE?

    What are the gods-level figures of the Experts outside the CDE?

    • Last Update: 2020-07-09
    • Source: Internet
    • Author: User
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    CDE this time under the "big effort", the external 626 experts, of which 35 are academicians! On 5 June, the CDE website updated a circular on the publication of the Measures for the Administration of External Experts in drug review centres and the list of the first batch of external experts from the Drug Review Centre (No4 of 2020)In order to ensure scientific justice in drug review, enhance transparency in drug review, improve the quality control system for review, and give full play to the important role of experts in drug registration review decision-making, the first batch of 626 experts was selected in accordance with the prescribed procedures to provide technical support and decision-making recommendations for the drug technical review process, the circular saidCDE's message has two points that need attentionFirst, this is the first time that CDE has implemented "external experts" measures, and with the publication of the first batch of lists, the second batch of external experts is expected to be on the agendaSecond, CDE published a list of 626 experts, there is no shortage of industry, a total of 35 academiciansThe stronger lineup and the larger scale also highlight the increased importance That CDE attaches to the review of pharmaceutical scienceCDE is the national food and drug regulatory agency drug registration technical review agency, to provide technical support for drug registration, is also a key part of the new drug from research and development to marketFor quite some time in the past, the couts were short of reviewers, the pace of reviews was slow, and the rules of the review scored a number of times on CDEBy the end of 2015, the backlog of CDE registration reviews had reached 23,000, reaching the "peak backlog"At that time, the State Council issued the Opinions on Reforming the Review and Approval System for Medical Devices of Pharmaceuticals (Statefa (2015) No44), which called for strict control of the approval of drugs in the market for over-demandStrive to digest the backlog by the end of 2016, as soon as possible to achieve the registration application and review of the number of annual access balance, 2018 to achieve the required time limit approvalAddressing the backlog of registration applications is one of the five main objectivesCDE has also embarked on a series of radical reforms: expanding the team of reviewers to speed up reviews, review clinical trial data, raise filing thresholds to reduce filings, and a significant improvement in the backlog of drug reviewsAccording to the 2018 Drug Review Report issued by CDE, the number of registration applications queued for review and approval at the end of 2018 has dropped from nearly 22,000 at the peak of September 2015 to nearly 3,440 (excluding registration applications that have been completed pending the applicant's response to supplementary information due to defects in the reporting information), which has largely eliminated the backlog of registrations but CDE also noted that although some progress has been made in the 2018 drug review process, there are still some problems First, how to further improve the review management system and standard system, improve the quality and efficiency of the review, improve the people's satisfaction and sense of acquisition, need to think deeply Second, the approval of talent structure and reform requirements are not suitable, the review capacity needs to be improved Third, the reform of the drug review and approval system has a long way to go, and some reform measures have not yet been fully implemented it is not difficult to guess that the selection of 626 experts, perhaps also one of the initiatives that CDE considers to address the above-mentioned issues, the main responsibilities of the external experts are mainly focused on participating in drug review consultation, demonstration, decision-making work organized by the Drug Review Centre, and providing operational advice and technical support for the technical review of drugs The specific way of working is divided into letter consultation, expert consultation and expert public demonstration meeting three notable, 35 academicians are among the 626 external experts As the highest level of experts in the country, academicians are the highest academic titles in science and technology established by the state E drug managers query the official website found that the current Chinese Academy of Sciences 823 academicians, 912 Chinese Academy of Engineering academicians, distributed in various fields, if the population of 1.4 billion people in China, these 1735 academicians, accounting for less than 0.01 percent of the proportion, but bear the most advanced scientific and technological forces E drug managers note that the 35 external academicians on the CDE list have made great achievements in their respective professional fields, and many are important figures who have made great contributions to the new crown outbreak, and have received more attention Zhang Boli Professor of Tianjin University of Traditional Chinese Medicine
    Zhang Boli has been engaged in clinical, educational and scientific research work in Chinese medicine for more than 40 years In the prevention and treatment of chinese medicine coronary heart disease, stroke, dementia and other major diseases have extensive experience He has presided over the systematic research of vascular dementia (VD), for the first time formulated the criteria for vascular dementia evidence type distype standards and by platform, fluctuation, and downward three-phase evidence treatment plan, and the creation of cerebrospinal fluid pharmacology method, which revealed the mechanism of the role of Traditional Chinese medicine on the protection of nerve cells, won the second prize of the national scientific and technological progress He conducted the first evidence-based study on secondary prevention of myocardial infarction in Chinese medicine, established a series of methods and key technologies for evidence-based evaluation of Chinese medicine, and promoted the overall improvement of the quality of clinical research in Chinese medicine Continuously undertake three national "973" projects, carried out a systematic study of the law of prescription agent distribution, created a new way to group distribution of Wu to create modern Chinese medicine, and developed a number of modern Chinese medicine Opened up the famous Chinese medicine secondary development field, set up a series of key technologies, improve the quality of Chinese medicine products and scientific and technological connotation, promote the upgrading of the Chinese medicine industry, won the first prize of national scientific and technological progress the outbreak of Wuhan, as a member of the central guidance group expert group, Zhang Boli came to Wuhan on the third day of the new year, has been fighting at the forefront Because of many days of fatigue, he did gallbladder removal surgery in Wuhan, after the 3rd day of surgery and put into work, he also humorously said: "liver and bile photo, I left the bile here." may 22, the plenary meeting of the Tianjin delegation to review the government work report, referring to the history of the Wuhan epidemic, the National People's Congress representative, Zhang Boli academician once choked down tears, the relevant video also spread widely on social media "I'm a normal person, I'm a normal person, I'm not a hero, " he says At the moment, doctors have to rush to the front, and that's the job , a researcher at the Institute of Biological Engineering at the Institute of Military Medicine of the , graduated from the Academy of Military Medical Sciences He is currently the director of the Institute of Biological Engineering of the Academy of Military Medical Sciences, researcher, doctoral tutor, professional and technical 5, major general rank her long-term commitment to the research of new vaccines and therapeutic drugs for highly pathogenic pathogenic microorganisms In 2003, she led a team that developed a new type of interferon, becoming the first drug to "block" SARS, and played an important role in the fight against SARS In addition, the recombinant Ebola vaccine it led to has broken through the world's challenges and allowed China's fully developed vaccine to go abroad also during the outbreak, Chen Wei quickly into the new crown vaccine research On May 22nd, at 21:00, the international academic journal The Lancet published online the results of the world's first phase I clinical trial of the new crown vaccine, led by Chen Wei's team, showing that the vaccine is safe and capable of producing an immune response to SARS-CoV-2 in humans Gaofu, researcher of the Chinese Center for Disease Control and Prevention, , academician of Chinese Academy of Sciences, fellow of the Academy of Sciences of developing countries, fellow of the American Academy of Microbiology, foreign academician of the European Molecular Biology Organization, fellow of the American Association for the Advancement of Science, foreign fellow of the Royal Society of Edinburgh, and fellow of the African Academy of Sciences Director of the China Center for Disease Control and Prevention, Deputy Director of the National Natural Science Foundation of China Gaofu's main research direction is the inter-species transmission mechanism of pathogenic microorganisms and molecular immunology, mainly engaged in T-cell identification, influenza virus and other cystic virus invasion molecular mechanism, avian influenza and other animal-derived pathogenic diseases inter-species transmission mechanism research , a researcher at the Shanghai Institute of Pharmaceutical Research, Chinese Academy of Sciences, was born in Chongqing on August 28, 1945, in Nanjing, Jiangsu Province He graduated from Fudan University in 1967 In 1982 and 1985, he received master's and doctorate degrees from the Shanghai Institute of Pharmaceutical Research of the Chinese Academy of Sciences Researcher, Institute of Medicine, Shanghai Institute of Medicine, Chinese Academy of Sciences, Director of the Academic Committee, Chief Scientist of the "973" Project He was the director of shanghai Drug Research Institute He was elected a member of the Chinese Academy of Sciences in 1999 and is mainly engaged in drug chemistry and innovative drug research Shi, a professor at Westlake University in , graduated from Tsinghua University and received his Ph.D from Johns Hopkins University in the United States in 1995 Structural biologist, Professor of Tsinghua University, Fellow of the Chinese Academy of Sciences, Fellow of the European Society of Molecular Biology, Foreign Fellow of the National Academy of Sciences, Foreign Fellow of the American Academy of Humanities and Sciences, was awarded the "Life Science Award" of the 2nd Future Science Award in 2017 He was vice president of Tsinghua University Good at the study of apoptosis and membrane protein The West Lake University, founded by the west lake, is a non-profit new higher education institutions organized by social forces and supported by the state, adhering to the "high starting point, small and refined, research-oriented" school positioning, focusing on science, life and health, cutting-edge technology and other directions to set up a first-level discipline Wang Chen , a member of the Chinese Academy of Engineering, graduated from the Department of Medicine of Capital Medical University in 1985 with a bachelor's degree in medicine He received his Doctor of Medicine degree in 1991 Postdoctoral research at the University of Texas School of Medicine in 1994 Since 1993, he has served as Deputy Director, Vice President and Dean of Respiratory Medicine department of Chaoyang Hospital in Beijing, affiliated with Capital Medical University, Deputy Director of the Beijing Respiratory Disease Research Institute, Vice President of Beijing Hospital of the Ministry of Health, and Director of the Respiratory Center In February 2013, he was appointed Deputy Director of the Science and Technology Education Department of the Ministry of Health and Family Planning of the National Health And Family Planning Commission, and promoted the work of national medical education and medical research From September 2014 to January 2018, he was the Director of the Sino-Japanese Friendship Hospital Wang Chen has been engaged in clinical, research and teaching of respiratory diseases for a long time, and has achieved many important innovations and entered the international guidelines for diagnosis and treatment To undertake national scientific and technological support, 863, 973 programs and the National Natural Science Foundation of key projects, the Ministry of Health industry research projects and other state-level scientific research projects More than 100 articles have been published in international authoritative medical journals such as the New England Journal of Medicine, the Lancet and the Ann Ann Med of Internal Medicine Won the first prize of the National Science and Technology Progress Award 1, the National Science and Technology Progress Award 2nd prize 3
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