April 11-12, 2024,State Food and Drug Administration verification center检查组专家一行3Person-to-person hospitalClinical Pharmacological Research Centerprogressive“He sprayed him with multiple tablets of hydrochloric acidStudy on human bioequivalenceThe project went on for a period of time2Days of on-site verification of drug registration clinical trials。

President of our collegeGu Haitide、Vice President Yuan Zhuojun,Corporate office directorTong Xiaoyun、He Jianchang, director of Clinical Pharmacological Research CenterAnd staff of relevant departments participatedOn the morning of April 11th现场核查First meeting。会上，检查The group leader read out the on-site inspection notice and related disciplines。Dean Gu Haichao对检查The arrival of the group of experts is welcomed, and it is hoped that the verification of experts will further promote the clinical trial of drugs in the hospital的Professional and standardized development。Vice President Yuan Zhuojun read the letter of commitment of the verified unit, and the verified project undertook the director of the professional clinical pharmacological research center He JianchangI made a detailed work report。

Experts focusviewed"Study on Bioequivalence of multiple tablets of Tapenta Hydrochloride in Humans"Project information,The authenticity, completeness, standardization and traceability of the test data were checked through the project data，以及The familiarity of the clinical trial team with the study protocols and procedures等。

On the afternoon of April 12, the on-site verification summary meeting was held in the Clinical Pharmacological Research Center.我院Vice President Wang Yun, organization office主任Tong XiaoyunChairman of the Medical Ethics CommitteeJiang Lijuan、He Jianchang, director of Clinical Pharmacological Research CenterAnd staff of relevant departments participatedSumming-up meeting。

Summary meeting, inspection teamThe experts affirmed the work of drug clinical trial institutions in our hospital, and pointed out the problems that need to be further improved in the work。Finally, our hospital successfully passed the scene核查。Vice President Wang YunThanks to the experts of the Inspection Team for their valuable advice,表示The agency will take this time核查As an opportunity,加强Manage the key links of GCP, ensure that the test process is standardized, the results are scientific and reliable, protect the rights and safety of the subjects, make GCP work as a key work to promote medical scientific research, and carry out clinical trial work more solidly and continuouslyTo improve the quality of drug clinical trials in our hospital,Inject new impetus into the development of the hospital。