The Provincial Drug Administration launches laws and regulations to strengthen the construction of medical device clinical trial inspection teams in our province
From February 27th to March 1st, the pre-job training course for professional and specialized medical device clinical trial inspectors (inspection experts) in Guangdong Province and the publicity and implementation meeting of the newly revised “Quality Management Standards for Clinical Trials of Medical Devices” were held in Guangzhou , to further improve the inspection ability and comprehensive quality of medical device clinical trial inspectors (inspection experts) in the province, and promote the promotion and implementation of the newly revised medical device clinical trial quality management regulations in our province. Su Shengfeng, the first-level inspector of the Provincial Drug Administration, attended the training class and gave a mobilization speech.
The meeting pointed out that the construction of a team of professional and professional inspectors is a major issue related to drug quality and people’s health. Innovating the working mechanism of clinical trial inspection of medical devices is one of the key tasks of the province’s comprehensive reform of drug supervision in 2023. We must further strengthen the quality of medical devices. The construction of the team of clinical trial inspectors has continuously strengthened the supervision of medical device clinical trial institutions and test projects by the provincial drug regulatory department. The meeting emphasized: first, to improve the political position and fully understand the significance of clinical trial inspection; second, to strengthen professional learning, so as to develop the true ability to take on the mission; third, to strictly abide by the bottom line and be a clean and self-disciplined inspector and inspection expert.
The training was carefully planned and carefully arranged in terms of course design, teacher selection, teaching content, etc., and invited authoritative experts from clinical trial institutions, the Medical Device Registration Management Department of the State Food and Drug Administration, and the Food and Drug Inspection Center of the State Food and Drug Administration. , as well as the relevant departments of the Provincial Drug Administration and the business backbone of the Provincial Drug Inspection Center to give lectures. The training content covers the interpretation of the newly revised “Quality Management Standards for Clinical Trials of Medical Devices”, key points of on-site inspection of medical device clinical trials and case analysis, analysis of key points of clinical trial contracts and ethical review, and introduction of key points of clinical trial protocol design, etc. The training teachers are authoritative, the teaching knowledge is professional, and the course content is rich. The combination of on-site lectures and exchanges and interactions has won unanimous praise from the students.
This pre-job training plays an important role in strengthening our province’s medical device clinical trial inspection capabilities, building a professional and professional medical device clinical trial inspector team with excellent business skills and excellent quality in the province, and will further improve our province’s medical device The inspection work related to clinical trials has laid a good foundation.
More than 300 business backbones of the province’s medical device supervision system, representatives of clinical trial institutions and university experts participated in the on-site training, and a total of 1,582 units and individuals participated in the online publicity and implementation meeting of the newly revised medical device clinical trial quality management standards. (Contributed by the Provincial Drug Inspection Center)
