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2019 Clinical Trial Biological Sample Analysis Management Training Course (Module C)

In recent years, the rapid development of drug research in China has driven the rapid development of analysis of biological samples in clinical trials industry, and the efficient operation and management of biological sample analysis projects are closely related to the efficiency and data quality of drug research and development. In order to improve the quality and efficiency of clinical trial biological sample analysis project, improve the quality of drug development, ensure the public demand for and safety of clinical medication, clinical trials of biological sample analysis project management training courses was held in Shanghai in July 2019 by National Medical Products Administration Senior Institute and Shanghai Xihua. This course explained and discussed the selection of biological analysis laboratory, and from three dimensions of manpower, time and cost, project management is explained and discussed.

Before the formal start of the training, Ms. Jieqiong Xie of The Institute of China Food and Drug Administration announced the opening of the class. Dr. Xiaohang Shen, general manager of Shanghai Xihua explained the content division of the C module course, and introduced the lecturers who attended the training to more than 50 students engaged in biological sample analysis. At the beginning of the course, Dr. Shen also showed the students' pre-class questionnaires. In response to widespread questions, instructors will also improve the curriculum to focus on the parts of the course that are more interesting to students.

In this Module C course, experts from various sectors of the industry, including senior experts from Xihua Team, were invited for each division of the course. Invited lecturers gave lectures on their respective topics and interact with students in depth.

During the three-day training, the lecturers not only explained the professional knowledge, but also invited the students to have a simulation training. The combination of theory and practice enables the students to better understand and apply the skills learned in vivid cases.

The course content not only involves the key links of the internal management of the laboratory, but also involves the communication and interaction of external cooperation and communication methods, which make CRO and the sponsors know more about each other's ideas, understand more mutually, and communicate more efficiently. Finally, Dr. Shen expressed his expectation for the industry and hoped that the participants of this training would return with full satisfaction.