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We offer the most professional and efficient medical device registration services in the country
We offer the most professional and efficient medical device registration services in the country
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On June 17, Shanghai Jiao Tong University (SJTU) hosted the 7th "Laboratory Safety and Standardized Management" Forum of the Shanghai Jiao Tong University (SJTU) Yangtze River Delta Innovative Medical Device Registration Research and Clinical Translation Series (YMRC), which was organized by SJTU Institute of Translational Medicine, Analytical Testing Center and Michigan College. The meeting was held in Shanghai, China.
The meeting was firstly introduced by Prof. Wang Jinwu, Director of the National Major Science and Technology Infrastructure for Translational Medicine (Shanghai) Innovative Medical Device Registration and Clinical Translation Service Center (NFTM-MRC), who suggested that the forum would focus on the theme of the 21st National Safety Production Month, "Comply with the Safety Production Law, Be the First Responsible Person", and introduced the participating experts. He also introduced the participating experts. The forum was attended by Mr. Peng Huasong, Deputy Director of Shanghai Jiao Tong University Laboratory Safety and Environmental Protection Center, Mr. Zhang Xianming and Mr. Zhu Shunying, Secretary of Shanghai Jiao Tong University Institute of Translational Medicine, Mr. Chen Feng, Director of Shanghai Jiao Tong University Analytical Testing Center, Mr. Zhang Zhaoguo and Mr. Zhang Yuping, Deputy Director of Shanghai Jiao Tong University Analytical Testing Center, Mr. Xu Hongyong, Director of East China University of Science and Technology Safety and Environmental Protection Office, Professor Liu Yang of Shanghai Jiao Tong University Michigan College, Mr. Duan Jiyi, Director of Quality Assurance Department of Suzhou WuXi AppTec New Drug Development Co. Ltd. The forum was hosted by Guo Shuyang from the Institute of Translational Medicine, Shanghai Jiao Tong University.
Deputy Director Peng Huasong said in his speech that June this year is the 21st national production safety month, to carry out in-depth study of General Secretary Xi Jinping's important remarks on production safety, and to carry out education and training activities on the production safety law. 2021, the Center for Laboratory Safety and Environmental Protection developed the Shanghai Jiao Tong University safety management approach, students and faculty entering the laboratory must go through comprehensive safety education training and assessment, and sign a The initiative further enhances the safety awareness and prevention ability of teachers and students. In addition, he especially emphasized the need to enhance the safety foundation support and guarantee ability, the need to strengthen the safety quality education, carry out a large number of scientific lectures and practical activities, and continuously promote the laboratory safety education work.
Secretary Zhang Xianming said that since the establishment of the Safety Office, he and the relevant responsible personnel have carried out laboratory restart and other safety management, emphasizing that laboratory safety management should be implemented into the daily routine. He introduced that this meeting would provide valuable experience for the participants from multiple perspectives, such as management of hazardous materials, details of test operations, and good test practices. Laboratory safety is an order that teachers and students need to maintain together, and it is a common value and the basis of the whole safety guarantee.
Secretary Zhang Xianming introduced the "National Major Science and Technology Infrastructure for Translational Medicine (Shanghai)", which is one of the key areas of the 12th Five-Year Plan and is designed and built with the goal of translational application of key common technologies for large-scale high-end medical equipment. It is a large-scale, integrated, systematic and comprehensive research facility, focusing on three major diseases, such as tumor, metabolic diseases and cardiovascular diseases, to carry out translational research and validation of drugs, reagents and devices, and has carried out a series of cross-research practices focusing on health needs and clinical problems. From laboratory to clinical application, the translational medicine team proposes ideas and concepts based on clinical needs, carries out research programs on various disease treatment technologies and devices with the support of a series of technical platforms, and constructs technical pathways that in turn obtain feedback through clinical validation, forming a complete medical translational system capability.
Director Xu Hongyong gave a course on "Cross Talk Laboratory Chemical Safety", sharing his personal experience of typical accident cases in laboratories of universities and enterprises, and he suggested that most of the hidden dangers of experimental safety are caused by irregular behaviors. Director Xu Hongyong explained the methods of laboratory risk management, including risk identification, risk assessment, risk reduction and emergency response, and introduced the specific measures of reagent safety management and the correct use of protective equipment in laboratories. He suggested the need to be aware of hazards in the laboratory and familiar with SDS while doing personal protection, and recommended relevant query websites and laboratory safety books for the participants.
Prof. Liu Yang presented "Examples of Laboratory Safety Operations in Medical Device Research", introducing the characteristics of cross-disciplinary laboratories and sharing the relevant management experience of foreign laboratories. He firstly introduced the layout of integrated laboratories in the intersection of engineering and biology, which need to have functional areas such as dry and wet separation of protective articles, mechanical facilities, and biological materials. Secondly, he suggested that biological laboratories need to strictly comply with biosafety classification requirements, should have standardized sanitary inspection and safety protection, and explained the basic methods of using and handling dangerous drugs. Finally, he shared the standard operation specification in the laboratory, and SOPs should be written for all basic operations to achieve the purpose of standardizing and unifying the operation and recording behavior among different operators, so as to reduce the probability of danger.
As the director of Quality Assurance Department of Suzhou Yao Ming Kang De New Drug Development Co., Ltd, Jiyi Duan is familiar with laboratory safety regulations and development quality supervision, and brings the participants concrete suggestions on the implementation of Good Laboratory Practices (GLP). The basic requirements of GLP include resources and organizational personnel, facilities and equipment, experimental protocols and standard operating procedures, samples and test systems, and results and quality assurance, and Director Jiyi Duan provided management methods and suggestions for each aspect.
Finally, Chen Feng, Secretary of Shanghai Jiaotong University Analytical Testing Center, summarized the meeting around safety and management. This forum was organized by several colleges of Shanghai Jiaotong University and the center, aiming to further improve safety management, standardize the experimental process and avoid safety accidents. He also expressed his gratitude to the experts for their excellent lectures and sharing.
The course attracted hundreds of attendees, and the lecture content was effectively matched with the theme of the 21st National Safety Production Month, aiming at solidly promoting the three-year action of national safety production special rectification, and striving to create a strong atmosphere of attaching importance to safety production and participating in safety development. In the near future, Shanghai Jiaotong University Innovative Medical Device Registration and Transformation Service Center will also continue to provide quality online courses. All online participants can apply to become members of Shanghai Jiaotong University Translation and Registration Center and become members of Shanghai Jiaotong University Registration and Transformation Family and get the opportunity of future academic notification and biomedical industry transformation services for free!