NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
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The training session on real world data research of medical devices was held in Lecheng pilot zone

2021-04-12 270

In order to implement the strategic deployment of the State Drug Administration and Hainan Province, and better provide services for enterprises in the Lecheng Pioneer Zone to conduct real-world research on licensed medical devices, the real-world data of medical devices hosted by the Hainan Provincial Real-World Data Research Institute The research training meeting will be held on April 12, 2021 in the Lecheng Pioneer Zone of Boao, Hainan. The purpose of the conference is to further strengthen the medical device companies' in-depth understanding of the policies, regulations, procedures, and research environment for conducting real-world research in the Lecheng Pioneer Zone, and jointly promote the compliant and efficient development of real-world research in the Lecheng Pioneer Zone.

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Fu Zhu, member of the Party Committee, Deputy Director of the Lecheng Pioneer District Administration, and Vice President of the Hainan Real World Data Research Institute (hereinafter referred to as the Zhenyan Institute) attended the meeting and delivered a speech.

Yao Chen, Professor of Peking University First Hospital and Vice President of Provincial Institute of True Research, Sun Xin, Professor of West China Hospital of Sichuan University and Vice President of Provincial Institute of True Research, Professor Tan Jing of West China Hospital of Sichuan University, and President of Hainan Boao International Optometry and Ophthalmology Hospital Prof. Chen Wei and Prof. Gao Pei, School of Public Health, Peking University, respectively, on "Design of Automated Collection Processes for Real-World Data", "Guidelines for Clinical Evaluation of Devices Supported by Real-World Evidence", "Research on Real-World Data Based on Special Diseases", and "Real-World Research". In-depth policy interpretation and academic exchanges were conducted in Exploratory Practice of Boao Lecheng Ophthalmology and Statistical Analysis of Evaluation of Treatment Outcomes Based on Real-World Data, which further improved the trainees' understanding and understanding of real-world data research.

Yao Chen, professor of Peking University First Hospital and vice president of the Provincial Institute of True Research, gave a special report titled "Design of Automatic Collection Process for Real-World Data"

Sun Xin, Professor of West China Hospital of Sichuan University and Vice President of the Provincial Institute of True Research, gave a special report on "Real World Evidence Supporting the Guiding Principles of Clinical Evaluation of Devices"

Professor Tan Jing from West China Hospital of Sichuan University gave a special report on "Real-World Data Research Based on Specialized Diseases"

Professor Chen Wei, President of Hainan Boao International Optometry and Ophthalmology Hospital, gave a special report entitled "Exploratory Practice of Real World Research in Boao Lecheng Ophthalmology"

Professor Gao Pei from the School of Public Health of Peking University gave a special report entitled "Statistical Analysis of Evaluation of Treatment Outcomes Based on Real World Data"

Wu Huabing, director of the Hainan Provincial Drug Administration, Li Yaohua, director of the Provincial Drug Evaluation Service Center, and Lin Youhai, director of the Provincial Drug Evaluation and Certification Center, participated in this training activity. There are also about 100 relevant staff from the Provincial Food and Drug Administration and medical institutions in the park who participated in the training.