On October 17, 2021, the annual conference of the Hainan Provincial Key Laboratory of Real World Data Research and Evaluation of the State Food and Drug Administration and the Scientific Summit of Clinical Research, Evaluation and Translational Supervision [Boao Lecheng Real World Clinical Data Application and Research] Training Course] Held in Hainan. Haikou was successfully held, attracting more than 450 scholars and business representatives to report.

The theme of the training course is "Related Policies of Boao Lecheng Real World Data and Application Practice of Real World Data", including 6 reports, and a total of 9 experts participated in speeches and discussions.

Sun Xin, Director of the State Food and Drug Administration Hainan Key Laboratory of Real-World Data Research and Evaluation and Professor of West China Hospital of Sichuan University, said in his speech that real-world research has become a hot academic topic in China. In recent years, it has also received full attention from the State Food and Drug Administration. On the occasion of the establishment of the key laboratory, the training class invited experts and researchers represented by speakers to conduct a comprehensive presentation and discussion around the real-world research topics of Boao Lecheng, promoting the application of Boao Lecheng real-world data in clinical research and clinical research. in clinical research. The application practice in the transformation, I hope all participants can return with fruitful results.

Fu Zhu, member of the party committee and deputy director of the Lecheng Pilot Area Administration, gave a report on the topic of "speeding up the construction of a free trade port and creating a new highland for medical openness". Deputy Director Fu Zhu introduced the overall planning and development goals of the Lecheng Pilot Zone, the licensed use of global innovative pharmaceutical devices, system integration innovation, innovative supervision models, Lecheng global special drug insurance, and clinical real-world data application pilots. "Bright" results.

The country's unique licensing policy of urgently needed imported medical devices has made the Lecheng Pioneer Zone an important test field for the national drug regulatory authorities to conduct real-world data research and application. Since the launch of the pilot work of clinical real-world data application, Lecheng has made continuous breakthroughs. In the next step, the Hainan Real World Data Research Institute will further draw on wisdom and leverage to strengthen the base’s scientific research capabilities, promote the clinical application of pilot varieties and real-world research, complete the construction of a real-world research platform in Hainan Province, and train high-end talents with master’s and doctoral degree programs. The first Boao International Conference on Real World Research on Pharmaceutical Devices will be successfully held, and Lecheng will be built into a real world research highland with international advanced level.

The second report is "Real-World Data Clinical Evaluation Research under Scientific Supervision" by Li Yaohua, Director of the Medical Device Technology Evaluation Center of the State Food and Drug Administration. Minister Li Yaohua reviewed the support policies and substantive progress of the Boao Lecheng Pilot Zone, pointed out the application scenarios of real-world data in the field of drugs and medical devices, and put forward corresponding compliance by analyzing the core issues of real-world data under scientific supervision Recommendations, providing valuable regulatory input for conducting real-world research.

Lin Kai, director of the Adverse Drug Reaction Monitoring Center in Boao Lecheng Pioneer District, delivered a report titled "Thinking of the Safety Monitoring and Evaluation of Licensed Drug Devices Based on Real World Data". From the perspective of regulatory agencies, Director Lin Kai reviewed a number of policies supporting RWD, introduced the current status of safety monitoring of Boao Lecheng licensed medicinal devices, and proposed that safety monitoring is a necessary measure to ensure the safety of licensed medicinal devices. He said that under the characteristics of licensed medical device monitoring of "implementing main responsibilities, carrying out active testing, and training professional foreign languages", Lecheng has formed a complete framework for conducting real-world research.

Chen Wei, vice president of the Ophthalmology and Optometry Hospital Affiliated to Wenzhou Medical University, introduced the "exploratory practice of real-world research on eye diseases in Boao Lecheng". Vice President Chen Wei, focusing on ophthalmology, reviewed the franchise policy and development process of Boao Lecheng Pioneer Zone, analyzed the application characteristics, data sources, design types and overall process of RWS in the Pioneer Zone, and emphasized the development of RWS in the Pioneer Zone. The key factors provide important guidance for the development of high-quality RWS.

The fifth speaker was Mao Lei, General Manager of Hainan Boyan Medical Research Co., Ltd. The title of the report was "Project Implementation and Management of Real World Data Research in Boao Lecheng". Starting from the policy of real-world research, General Manager Mao Lei focused on Boao Lecheng, formulated the overall process for the landing of licensed pharmaceutical equipment, and refined all aspects of project implementation and management, so that researchers such as enterprises can use real-world data to conduct exploration and research set an example.

Li Yanlong, a lawyer from Haotianxin and Law Firm, explained the "Analysis of 'Data Compliance' in the Process of Real-World Data Research". Starting from laws and regulations, lawyer Li Yanlong analyzed the special considerations for the application of real-world data in Boao Lecheng, explained in detail the compliance requirements for the collection of personal information and data use in real-world research, and carried out research for the reasonable, compliant and legal application of real-world data. Provides solid legal protection.

After each session of the report, the hosts of the training class, Professor Sun Xin, Director Lin Kai, Professor Tan Jing, and Dean Li Xiaotuo, will briefly condense the themes of the report experts, and make wonderful comments to drive the experts and scholars on the scene. Think deeply. Finally, Dean Li Xiaotuo made a brief summary.

The conference gathered leaders from the State Food and Drug Administration, the Hainan Provincial Drug and Medical Device Evaluation Center, the Boao Lecheng Pilot Area Administration, the Boao Pilot Area Adverse Drug Reaction Monitoring Center and other departments, as well as real-world research and its methodology Experts from the Institute have closely discussed the application practice, method and technology of real-world data research, promoting the clinical research and transformation of real-world data, and assisting the integrated development of "government-industry-academy-research-application".