On August 30, the training class of real-world studies of drugs was opened at Lecheng Pilot Zone, co-hosted by Hainan Institute of Real World Data and Lecheng Clinical Research Center. The opening ceremony was presided over by Fu Zhu, a Party committee member and deputy director of Lecheng Administration and vice president of Hainan Institute of Real World Data. Yao Chen, a professor with Peking University First Hospital and vice president of Hainan Institute of Real World Data, delivered a speech.

The training aimed to promote the construction of clinical trial institutions of drugs, strengthen the mastery of knowledge such as GCP by clinical research staff of drugs, ensure that clinical research of drugs go smoothly, cultivate first-class research teams and hospitals, and accelerate the real-world studies.

The training this time has been supported by a strong faculty, with lecturers including renowned experts and scholars such as Professor Yao Chen with Peking University First Hospital and vice president of Hainan Institute of Real World Data, professor Xu Zhongyuan with Southern Medical University, Shen Yifeng, office director of Shanghai Mental Health Center, Su Yuju, deputy dean of the Institute of Marxism, Hainan Medical University, and executives of enterprises such as Xie Xingwang, chairman of Beijing Corregene Biotech Co., Ltd., and He Yan, deputy director in charge of audit and training of Talent Medical Consultation.

The training covered a rich variety of contents, including development and commercialization of medical products, the new edition of GCP of China and international regulatory comparison, filing of clinical trial institutions of medical products and construction of the research system, statistical considerations in the clinical research design, quality control system for clinical researches of the sponsor, data management and source data tracing of clinical researches, ethical review of clinical research schemes.

Affected by the pandemic, the training was held online, which was participated in by more than 100 trainees from posts such as clinical research, GCP declaration and ethical review of medical institutions, drug manufacturers and developers, and CRO companies.

Yao Chen, a professor with Peking University First Hospital and vice president of Hainan Institute of Real World Data, interprets the statistical considerations in clinical research design, data management and tracing of clinical researches.

Xie Xingwang, chairman of Beijing Corregene Biotech Co., Ltd. and a member of the Specialized Committee of Clinical Application of Medical Biotechnology, explains the R&D and clinical commercialization of medical products.

Xu Zhongyuan, office director of the National Drug Clinical Trial Institution, Southern Hospital, Southern Medical University, explains the filing of clinical trial institutions of medical products and the construction of research system.

Shen Yifeng, office director and ethics committee member of Shanghai Mental Health Center, and a researcher and doctor certified by the US Association of Clinical Research Professionals (ACRP), introduces the latest edition of GCP of China and international regulatory comparison.

 He Yan, deputy director in charge of audit and training of Talent Medical Consultation, explains the duties of each party and the sponsor in the clinical trials, and the quality activities of monitoring and auditing performed by the sponsor in clinical trials.