[Live Broadcast] The Fourth China Forum on Innovative Drugs will be successfully held in 2020
The Fourth China Innovative Drug Forum was successfully held on the morning of October 17, 2020. The forum focuses on the exchange and discussion on the basic ideas of innovative drug R & D in China, such as policies, strategies, scientific laws, risk control and internationalization strategies, and shares and exchanges on the international new progress and prospect prospects of innovative drug R & D. Leaders and experts attending the forum included Director Jiao Hong of China Food and Drug Administration, Yin Yong, Vice Mayor of Beijing, Chairman Liu Jingzhen of China Pharmaceutical Group Co., Ltd., Academician Chen Kaixian of Chinese Academy of Sciences and President Li Bo of National Institutes for Food and Drug Control. In addition, more than 100 editorial board members of Chinese Journal of New Drugs, more than 500 hospitals and enterprise experts and scholars attended the meeting. Dr. Gu Zheming, General Manager of Value Pharmaceutical Services Co., Ltd. and Chief Drug Metabolism Expert of Yeedozencom, was invited to give keynote report and participate in round-table discussion!
Venue Fact
Director Jiao Hong of China Food and Drug Administration attended the forum and delivered a speech pointing out that the pharmaceutical industry is related to people's health. The 19th National Congress of the Communist Party of China has raised the maintenance of people's health to the height of national strategy and made great measures to implement the Healthy China Strategy. Innovation is an important impetus for the healthy and sustainable development of the pharmaceutical industry. Standing at a new historical starting point, CFDA will vigorously carry forward the great spirit of anti-epidemic, always remember the responsibilities and missions to ensure the medication safety of the people, encourage and support the innovative development of the pharmaceutical industry, further improve the regulatory system, consolidate the reform achievements of deepening review and approval, strengthen the ability of whole-life cycle supervision and drug supervision, and vigorously promote the healthy development of the pharmaceutical industry. We hope that the China Forum on Innovative Drugs and the Chinese Journal of New Drugs will continue to play a platform role, pay attention to hot issues in the field of new drug research and development, continuously improve the academic level of journals, and make every effort to promote the innovative development of China's pharmaceutical industry!
Academician Chen Kaixian of the Chinese Academy of Sciences gave a report entitled "Progress in the R & D of Innovative Drugs in China", which mainly introduced the overall trend of life science development, the development of innovative drugs in China over the past decade, new opportunities and new challenges in the development of innovative drugs in China, and the overall goal of new drug R & D from 2021 to 2035.
Wang Tao, Chief Reviewer, Center for Drug Evaluation, CFDA, introduced the background and content of the revision of Good Clinical Practice for Drugs. In the past 30 years, great changes have been made in the design and implementation of drug clinical trials. In this context, China has revised the GCP by referring to the common international practice, ICH-GCP (R2) and combining with China's national conditions. This revision includes: (1) emphasizing stakeholder responsibilities; (2) enhancing subject protection; (3) establishing a quality management system; (4) optimizing safety information reporting processes and requirements; (5) planning the application of new technologies; and (6) referring to international clinical regulatory experience.
Director Wang Jianan of Center for Food and Drug Inspection of CFDA introduced the Verification and Common Problems of Drug Clinical Trial Data, mainly focusing on the revision of verification procedures and key points, on-site verification of drug registration clinical trials and common problems in verification.
The afternoon meeting was chaired by Professor Wei Shuyuan from the General Hospital of China Pharmaceutical Industry Research Institute, and the keynote speeches were made by Professor Liu Yanning from the General Hospital of the Chinese People's Liberation Army, Professor Sun Tieying from Beijing Hospital, General Manager Gong Zhaolong from Xuedi Medicine, Vice General Manager Tao Weikang from Jiangsu Hengrui Medicine Co., Ltd., General Manager Ma Yuan from Zhongji (Beijing) Certification Co., Ltd., and Dr. Gu Zheming from Value Pharmaceutical Services Co., Ltd.
Dr. Gu Zheming, General Manager of Value Pharmaceutical Services Co., Ltd., Chief Drug Metabolism Expert of Yidu Zhengkang, introduced "The Importance of Human Mass Balance Test for Marketing Application of Innovative Small Molecules". The human mass balance test is mainly used for: first, to identify and quantify the circulating parent drug and its metabolites; second, to elucidate the main elimination pathway of the test substance in the human body. Human mass balance test is a clinical pharmacology study that is easily ignored. According to US FDA-MIST and ICH-M3 (R2), it should be carried out as early as possible in the drug development process. The human mass balance test has been used in the study of innovative drugs such as celecoxib, anlotinib, pyrrolizine, and regliptin. Yidu Zhengkang and Jiangsu Wanlue have rich experience in innovative research and registration and participated in the human substance balance test and clinical study of some innovative drugs.
Dr. Zheming Gu attended the on-site round-table discussion
Dr. Zheming Gu attended the on-site round-table discussion
Tomorrow's notice
Tomorrow, Dr. Yang Zhenyu, Chief Scientist of Zhengkang Biostatistics, will report New Thoughts on New Drug R & D and Clinical Application under Real Data Evidence at Sub-forum 2 (Clinical Trial Risk and Quality Management). Attention!
