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Our Hospital Successfully Completed the Clinical On-site Verification of the Bioequivalence Project of "Flunarizine Hydrochloride Capsule" by the National Bureau Which Greatly Improved the Quality

 Hits: 3460 Time: 2021-05-05

From April 14 to 16, 2021, the expert group of the Audit and Inspection Center of the State Drug Administration conducted a clinical on-site verification on the Bioequivalence Project of "Flunarizine Hydrochloride Capsule" undertaken by our hospital.


The first meeting was held on the morning of 14th. Yan Jing, the secretary of the Party Committee of our hospital, the director of drug clinical trial institution and head of phase I clinical trial laboratory; Shou Xiaoling, the deputy director of Science and Education Department and the director of institutional office; Zhang Wanggang, the deputy director of institutional office and the director of Phase I Clinical Trial Operation; the secretary of Ethics Committee - Zhang Lingxi; enterprise representatives attended the meeting and reported on the implementation of the project.


During the verification, the expert group checked the authenticity and compliance of the project references and original data in all aspects. Based on the rigorous verification style, the expert group put forward valuable opinions to our institute. The institutional leaders and research team of our institute attach great importance to the problems found in the verification, carefully verify and give detailed answers.


At the final meeting, the expert group first affirmed the work of the organization and the completion of the project, and reported and exchanged the problems found in the on-site verification. On behalf of the hospital, Vice President Jin Xiaoqing expressed heartfelt thanks to the Inspection Team for their hard work and guidance to the clinical trial project of our hospital. In the follow-up, we will learn from experience, complete the clinical trial project more rigorously, continuously improve the quality and strive for a higher level.