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2018 Clinical Trial Biological Sample Analysis Technology and Quality Management Training Class

With the idea of 'sharing industry experience and making drugs well together', CFDA advanced research institute and Shanghai Xihua held the training course on biological sample analysis technology and quality management of clinical trials (module A) in Shanghai from May 26 to 30, 2018. During the training course, nearly 50 students from all over the country received systematic training on the relevant laws and regulations and professional knowledge of clinical biological sample analysis, and the lecturers guided the trainees to deepen their understanding of GLP and GDP. The trainees completed the training task with high quality and spoke highly of the training class in terms of organization, course arrangement and lecturers.


This training class is the second cooperation between Xihua and CFDA. Founded in 2015, Xihua is a CRO company committed to providing integrated services of pharmaceutical clinical research with bioanalysis as the core. At present, it has established extensive cooperative relationship with more than 50 domestic and international well-known pharmaceutical companies and clinical CRO. The management team has successively worked in international well-known pharmaceutical companies and CRO, and is proficient in the relevant laws and regulations and quality systems of biological analysis in many regulatory departments at home and abroad. It has led the team to pass the inspection and certification of China CFDA, the United States FDA, OECD and the European Union for many times, and the projects it undertook have been generally accepted by Chinese and western drug regulatory agencies. With its rapid development, Xihua has the courage to shoulder its social responsibilities.


Xihua would like to share years of experience in implementing Chinese and western industry norms with domestic insiders and contribute to improving the overall quality level of China's biological analysis industry.

This training class has broken through the traditional teaching-based teaching mode in the past, and adopted the teaching method combining theory and practice. It is composed of three parts: classroom teaching, experimental operation and hot topic discussion. In the class, Dr. Jinsong Xing first explained the importance of bioanalysis in drug development and BE research, and Dr. Xiaohang Shen then introduced the basic knowledge of bioanalysis to the students from both technical and regulatory aspects. In addition, Xihua’s Lanjin Qu, Hao Li, Jia Liu, Lihong Shi, Xuekai Liang gave lectures to the students respectively targeting on laws and regulations, the development and optimization of biological analysis method and the difficulties in biological analysis. At the same time we also invited Jiang Luo from Chinese Academy of Sciences Shanghai, application engineer Ning Liu of Seymour Fly, Fengju Chen from Shanghai Drug Evaluation and Verification Center, and Yin Xiong from Xihua, starting from their own professional field, at the same time of teaching to share their experience in industry for many years engaged in biological analysis, and for the students to answer questions and discussion.


In addition to the one-way teaching mode, the hot topic discussion is also carried out in full swing. Seminar hosted by Dr. Xiaohang Shen and Yin Xiong selected the hot topic in biological analysis combined with the latest laws, regulations and policies at home and abroad, together with the students to explore causes of the problems and solutions to communicate with the trainees, striving for putting forward more solution to the problem in line with the regulations in the process of the biological analysis in the future.


In experimental operation, Li Li with nine years’ experience in biological analysis led nine instructors, including Lanjin Qu, Yin Xiong, to help answer questions, Taking the weighing of standard products, the preparation of reserve liquid and working liquid, and the sample pre-treatment operation as examples, the trainees were instructed how to complete the experimental operation and complete the standardized experimental record under the GLP specification. During the experiment, the instructors pointed out the irregularities and wrong operations of the students one by one. The students asked for advice with an open mind and questioned them reasonably. Under the guidance of the instructors, they made every effort to ensure the authenticity, accuracy and preciseness of the experimental operation.


At the end of this training course, students said that they not only deepened their understanding of biological sample analysis technology and specifications, but also deepened their cognition of how to conduct biological analysis in accordance with CFDA regulations. In the conclusion of the training course, Dr. Jinsong Xing said, 'As a CRO, we hope to share our experience in biological analysis, make progress together, improve the overall quality level of China's biological analysis industry, and make contributions to China's pharmaceutical industry!'


In addition, the successful conclusion of this training class cannot be achieved without the intensive preparation of Xihua's partners. We also want to thank the students for their painstaking participation in the 5-day high-density training. After 20 days, module B will be arranged!