In order to deeply implement the guideline of the third meeting of the leading group for the pilot program of medical product real-world data application in 2021, fully unleash the role of NMPA Drug and Medical Device Regulatory Science Research Base in leading research and integrating resources and promote the real-world studies in Lecheng at a faster pace, on January 15, Hainan Institute of Real World Data organized and held an expert seminar on real-world studies in Beijing.

Aiming to address actual problems, the seminar invited experts and scholars from related areas such as pharmacology, ethics, methodology, law and big data management to have an in-depth discussion on related issues to be urgently addressed in real-world study such as human genetic resources, ethics and informed consent review, and related work of Hainan Real-world Study Platform such as data security and ownership, privacy protection, data sharing and running mechanism.

Based on their rich professional knowledge and practical experience and the actual conditions and characteristics of the pilot program of real-world data application in Lecheng, under the precondition of guaranteeing the patients’ rights and benefits and data security, the attendees put forward many constructive ideas and suggestions on how to improve the quality and usage efficiency of real-world data and promote the real-world studies in a compliant and efficient manner.

The seminar also solicited opinions on the research projects and postgraduate program to be launched by Hainan Institute of Real World Data in 2022. Entrusted by Gu Gang, the Party committee secretary and director of the Lecheng Administration, Fu Zhu, deputy director of the Lecheng Administration and vice president of Hainan Institute of Real World Data, said, in 2022, the Lecheng Administration will fully implement the spirit and deployment of the third meeting of the leading group for the pilot program of medical product real-world data application in 2021, further increase the funding for scientific research programs of real-world study, welcome and encourage experts and scholars from related fields to be actively involved in related research topics of real-world study and the postgraduate program in the orientation of real-world study application.

Finally, the seminar reached a consensus on the work planning of Hainan Institute of Real World Data in the next step. In 2022, the Institute will insist on systematic planning and overall resource planning and integrate the strengths and resources of each related party such as regulatory authorities, clinical research institutions, colleges and universities, research institutes and pharmaceutical developers according to the deployment of the aforesaid third meeting to establish and perfect the mechanisms for project management, talent cultivation and international exchange of the Institute, promote the completion of regulatory science research programs, further perfect the functions and operating mechanism of Hainan Real-world Data Platform, so as to build the Lecheng Pilot Zone into a new clinical research focus and a real-world study highland in China and contribute the “scheme of Lecheng” and “strength of Hainan” to the development of the national regulatory science cause.