To address the new trends in global regulation of pharmaceuticals and medical devices, promote the upgrading of clinical trial quality systems, and adapt to the high-quality and efficient development of clinical trials under new circumstances, the "The 2025 Training Program on Quality Management (GCP) and Ethical Review Enhancement for Drug and Medical Device Clinical Trials " was successfully held on April 19, 2025, through a hybrid online-offline format. Co-organized by the Chengdu High-tech Zone Health Bureau, Chengdu High-tech Zone Bioindustry Bureau, and Chengdu Medical College, and jointly hosted by the Chengdu High-tech Medical Association, the First Affiliated Hospital of Chengdu Medical College, the Regional GCP Alliance, and the Regional Medical Ethics Review Committee, with support from the Chengdu Tianfu International Bio-Town Management Committee and the In Vitro Diagnostics Industry College of Chengdu Medical College, the event attracted nearly 4,500 participants from medical institutions, pharmaceutical companies, CRO/SMO organizations, and clinical research professionals.
The opening ceremony, chaired by Professor Zhou Peng, Vice President of the First Affiliated Hospital of Chengdu Medical College, featured speeches by distinguished guests including Zhang Tao, Standing Committee Member of the Party Committee, Vice President of Chengdu Medical College, and Dean of the In Vitro Diagnostics Industry College; Liu Gang, President of the First Affiliated Hospital of Chengdu Medical College; and Ai He, Vice Secretary-General of Chengdu High-tech Medical Association.
Dean Zhang Tao emphasized the college’s commitment to fostering interdisciplinary collaboration, deepening a "standards-driven and innovation-oriented" education system, and cultivating versatile professionals with both technical expertise and humanistic values. He highlighted plans to reshape clinical research paradigms and integrate scientific ethics into training programs to fuel innovation in clinical trials.
President Liu Gang underscored the critical role of Good Clinical Practice (GCP) institutional standardization in advancing hospital research capabilities. He advocated for strengthening dual-track mechanisms in ethical review and risk management while fostering researchers’ compliance consciousness. He called for deeper integration of quality management systems with clinical practices to create a virtuous cycle in medical education and research.
Vice Secretary-General Ai He noted that the training established a cross-sector innovation platform, facilitating knowledge sharing and fostering regional clinical research collaboration. He expressed hopes for nurturing GCP talent with both global perspectives and localized expertise.
The conference featured lectures by renowned experts, including Professor Zheng Li from West China Hospital of Sichuan University, Professor Li Su from Sun Yat-sen University Cancer Center, Professor Yu Qin from West China Second Hospital, Professor Zeng Jieping and Professor He Yan from Chengdu University of Traditional Chinese Medicine Affiliated Hospital, and Professor Lu Qi from Renji Hospital, Shanghai Jiao Tong University School of Medicine. Through "theoretical frameworks + case studies," they delivered comprehensive insights on six key topics:’Management System Development and Common Issues in Clinical Trial Institutions; Ethical Challenges and Solutions in Medical Research Proposal Writing; Standardization of Medical Ethics Review Systems; Common Audit Findings and Core Elements of High-Quality Clinical Trials; Performance Evaluation Systems for Clinical Trials; Quality Assurance in Ethics Committee Reviews’.
Two panel discussions were notably conducted: The first explored "Multi-party Collaboration: Building a New Ecosystem for High-Quality Drug and Medical Device Clinical Trials" from perspectives of sponsors, investigators, and institutional offices. The second addressed ethical review system development, covering implementation standards, cross-institutional recognition mechanisms, and comprehensive participant rights protection.
Following the conclusion of the training program, all participants responded enthusiastically and reaped substantial benefits. They not only systematically mastered emerging technologies and regulatory updates in the field of drug and medical device clinical trials, thereby comprehensively refreshing their professional knowledge frameworks, but also deepened their understanding and application of Good Clinical Practice (GCP) guidelines and ethical norms. This broadened the scope of their scientific research perspectives, laying a robust methodological foundation and offering practical guidance for conducting high-level clinical research in the future.
Through this training, clinical trial practitioners effectively strengthened their compliance awareness with GCP standards and ethical literacy, achieving dual advancements in both theoretical expertise and hands-on skills. The program also optimized standardized workflows for drug and medical device trials, propelling the clinical research capabilities of medical institutions toward a structured, progressive development pathway—establishing a standardized foundation, advancing professional competencies, and aligning with global benchmarks.
