On June 17, 2021, the Lecheng International Medical Tourism Pilot Zone Administration, the China Clinical Research Community, and the Hainan Real World Data Research Institute jointly held the "2021 Clinical Research Lecheng Closed-door Seminar" in the Lecheng Pilot Zone. The purpose of this symposium is to promote the development of the Lecheng Pioneer District in areas such as clinical research and real-world research. The participants discussed in depth how to better gather the strengths of all parties, establish a benign interaction between the Lecheng Pioneer Zone and outside the province in terms of scientific research cooperation and industrial collaboration, and explore innovative clinical research models to promote the development of real-world research and help Promote the landing of international advanced medical equipment in the Hainan Lecheng Pilot Zone and other topics.

The symposium was attended by Han Wenxin, co-convener and secretary general of China Clinical Research Community, Professor Weng Jianping, co-convener of China Clinical Research Community and Executive Director of Clinical Research Hospital of Chinese Academy of Sciences (Hefei), and General Global, the sponsor of China Clinical Research Community. Feng Qingming, Chief Medical Officer of the Medical Group, Yuan Peng, National Head of China Life Jiayuan, China Life Insurance Group, a member of the China Clinical Research Community, Dr. Fan Xiaodong, former Executive Deputy Director of the Device Review Center of the State Food and Drug Administration, and Zeng Zeng, President of Hainan Nanhai Health Industry Research Institute Professor Yu, Senior Partner of Beijing Bairui Law Firm Gong Nan, Director of Global Health Industry Innovation Center (GHIC) Wang Jingjing and other guests discussed "Relevant Policies for Clinical Research and Real World Research", "The Key to Carrying out Clinical Research and Real World Research" Issues", "cooperation and support in clinical trial research and real-world research", and "pharmaceutical and device enterprises' needs for clinical trial research and exploration of cooperation models between parties and enterprises" were shared and discussed.

The Lecheng International Medical Tourism Pilot Zone is the first place for real-world research in my country. In November 2020, the State Food and Drug Administration issued the "Technical Guidelines for the Use of Real-World Evidence for Clinical Evaluation of Medical Devices (Trial) (2020 No. 77)" Text)", which proves that the time to carry out the pilot application of clinical real-world data for medical devices is gradually ripe. At the end of November 2020, the National Medical Products Administration’s Drug and Medical Device Regulatory Scientific Research Base established in the Lecheng Pioneer Zone was unveiled and the Hainan Real World Data Research Institute was established. The Lecheng Pioneer Zone will focus on real-world research and further promote real-world research. World evidence for drug and medical device registration and regulatory decisions. At this discussion meeting, the participants generally believed that the Lecheng Pioneer District has inherent policy advantages and technical advantages in carrying out real-world data research, but more participants are required to import resources to jointly promote the Lecheng Pioneer District in real-world data research. development of.

Liu Zhefeng, member of the party committee and deputy director of the Lecheng Pilot Area Administration, attended the seminar and delivered a speech. Yao Chen, deputy director of the Hainan Real World Data Research Institute, introduced the relevant policies of real world data research and the project situation of Lecheng real world data research.

At this seminar, the China Clinical Research Community and the Hainan Real World Data Research Institute discussed the cooperation model between the two parties and reached a cooperation intention - the China Clinical Research Community will give full play to its advantages in experts, scientific research, transformation, and industrial implementation, combined with Hainan With the professional advantages of the Real World Data Research Institute in the field of real world data research and the location advantages of Hainan Free Trade Port, the two parties will work together to strengthen the exchanges and interactions between the Lecheng Pioneer Zone and other provinces in the field of scientific research and industrial development to help more Many advanced pharmaceutical and device companies have landed in the Lecheng Pioneer Zone, accelerated clinical development, and accelerated the transformation of results. In addition, the two parties will work together to promote more advanced medical equipment projects to carry out real-world data research in the Lecheng Pilot Area, and publicize the results of the real-world data research in the Lecheng Pilot Area.  

This seminar is organized by the China Clinical Research Community from the end of 2020 by the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, the Clinical Research Hospital of the Chinese Academy of Sciences (Hefei), General Global Medical Group, CCD Strategy Group, Health Industry, Boao Medical Innovation Research The hospital and other six parties jointly initiated the initiative, and after the first batch of member units were determined in the first quarter of 2021, similar activities were held in the Lecheng Pioneer Area for the first time. The China Clinical Research Community is currently the only national ecosystem in the field of clinical research in China that is jointly built by government, medicine, industry, academia, research, and finance. In addition to the three organizers, the co-organizers of this closed-door meeting are Yiling Hospital Management Group and Boao Yiling Life Care Center, and participating companies include Hainan Boao Lecheng Clinical Research Center, Danaher, Bayer, Astellas and other multinational pharmaceutical equipment. The company and the organizer Hainan Triangle Health Management Co., Ltd. jointly proposed to fully support the first Boao International Conference on Real World Research on Pharmaceutical Devices.