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Municipal Health Commission Held a Training on Preparation Management of Stem Cell Clinical Research Preparations
From:Beijing Municipal Health Commission
Date:12/19/2018

 

On November 28th, the Municipal Health Commission held a training course on preparation management of stem cell clinical research preparations. More than 120 people including chiefs of the Beijing Recording Organization of Clinical Research on Stem Cell and the relevant scientific research institutions, leaders of the projects on stem cell clinical research and the preparations production, the quality management personnel, and the relevant personnel of the Tianjin and Hebei recording organizations participated in the training.

For the first time, the training course issued the “Guidelines for Quality Management of Stem Cell Preparation in Stem Cell Clinical Research by Medical Institutions”, which was developed by the Beijing Municipal Health Commission, and was interpreted by the researcher Meng Shufang, Cell Department of China Food and Drug Administration. Zhang Fengmei from the Drug Production and Supervision Department of the Beijing Municipal Drug Administration introduced the GMP system. Secretary-General Wu Zhaohui of China Pharmaceutical Biotechnology Association explained the "self-discipline inspection of quality management of stem cell preparation production". Director Yuan Baozhu of the Cell Resource Storage and Research Center of National Institutes for Food and Drug Control gave a special lecture on "Quality Control Standards and Testing Methods for Stem Cell Preparation Production".

Director Wang Jinqian of the Planning and Evaluation Division of the National Health Commission came for guidance and put forward specific requirements for the institutional record of stem cell clinical research, project recording, and construction of quality management system of stem cell preparation, emphasizing the main responsibility of the institution. The institutions should uphold the awareness of law, bottom line and responsibility, strengthening post-event supervision, ensuring the standardization and orderly development of clinical research on stem cell.