In recent years, the registration of drugs and medical devices in China has entered the era of globalization, which puts forward higher requirements for the clinical trial process of drugs and medical devices.In order to further promote the standardized development of clinical trials, improve the quality of clinical trial implementation, and adapt to the high-quality and efficient development of clinical trials in new forms, help applicants, CRO, SMO and clinical trial institutions to deeply study and understand the work requirements of current laws and regulations, and effectively protect the safety and rights and interests of subjects.The "2024 Quality Management Training Course for Clinical Trials of Drugs and Medical Devices" co-sponsored by the Chengdu High-tech Zone Regional GCP Alliance, the First Affiliated Hospital of Chengdu Medical College and the Chengdu High-tech Medical Association was successfully held on June 15, 2024, from colleagues from medical institutions, pharmaceutical enterprises and in-hospital medical care inside and outside the province. 21,000 people online and offline participated in the training.
The opening ceremony of the meeting was presided over by Professor Zheng Lingli of the First Affiliated Hospital of Chengdu Medical College. Xiao Jiangwei, Vice President of the First Affiliated Hospital of Chengdu Medical College, and Ai He, Vice President and Deputy Secretary-General of Chengdu High-tech Medical Association, attended the meeting and delivered speeches.
Vice President Xiao Jiangwei said that the construction of GCP in medical institutions is not only a requirement for the performance appraisal and grade evaluation of national third-level public hospitals, but also an important step in the hospital's strategy and high-quality development.
Vice President Ai He said that through this training, it not only enlivened the academic atmosphere, but also increased cohesion and opened up popularity. I hope that more colleagues will participate in GCP, improve the overall level of GCP, and contribute more to the research and development of new drugs.
The meeting invited Professor Chen Tao of Chengdu Second People's Hospital, Professor Yu Qin of West China Second Hospital of Sichuan University, Professor Xiang Li of the Affiliated Hospital of Southwest Medical University, Professor Zhang Qing of Ai Kunwei Medical Technology (Shanghai) Co., Ltd., Professor Jiang Hui of Zhangzhou Hospital Affiliated to Fujian Medical University, Professor Zhang Xudong of Sichuan Cancer Hospital, Professor Zheng Shuli of AstraZeneca Global R&D Center and Professor He Qingling of Yibin Second People's Hospital gave lectures.Experts combined the terms of laws and regulations and the "practice" experience in clinical trial practice, management and verification respectively, for the Construction and Practice of Clinical Trial Performance Evaluation System, Learning Experience of Supervision and Inspection Points and Judgment Principles, GCP Project Management Construction Based on the Perspective of Departments, and Clinical Trial Center Selection Points and GCP Industry Development, Analysis of Clinical Trial Ethics On-site Verification Points, Clinical Trial Contract Review and Funding Management Points, Solutions for Exploring Patients' Participation in Early Strategies for Clinical Trials, and Analysis of Clinical Trial Data On-site Verification Points have been carried out with multi-angle, all-round and systematic training.
After this training, the students said that they had benefited a lot and were deeply inspired. They not only learned the new policies and requirements of clinical trials, updated the new technologies and knowledge of drug/medical device clinical trials, but also improved GCP and ethical awareness, broadened clinical research ideas, and carried out various clinical practices in the future. The examination and clinical research have provided guidance and help.
Through this training, the GCP awareness, ethics and moral awareness of hospital clinical laboratory personnel have been further strengthened, the theoretical level and clinical trial technology level of clinical trial personnel have been improved, the clinical trial process of drug/medical device clinical trials has been standardized, and the hospital clinical trial work has been promoted to a higher quality development.
