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Drug Clinical Trial Institution Conducted 2016 GCP Training
Source: Posted Date:11-25-2016

The 2016 Good Clinical Practice (GCP) training meeting was held by China-Japan Friendship Hospital (CJFH) in the international conference center of Chunhui Yuan in Beijing on November 19, 2016. This training, organized by the Drug Clinical Trial Institution of CJFH, was hosted by Director Zhang Xianglin. With the theme of the new situation, new requirement and new opportunity of clinical trial, about 300 people from 30 departments of our hospital attended the training, involving 13 specialties, 14 proposed specialties, 5 departments like Pathology Department and Clinical Department for medical devices and reagents.
 
Vice-President Gao Haipeng attended the opening ceremony of the training meetingand delivered the opening address, providing major analysis for the critical requirements for the supervision of the clinical trial and advocating the medical staff of our hospital to clarify situations, specify problems, improve capacities, catch opportunities and respond to challenges.
 
As for the training, we invited experts including Li Jianming, the Deputy Director of China Food and Drug Administration (CFDA), Professor Xiu Qing, the senior expert of drug clinical trial inspections in Shanghai Changzheng Hospital that affiliated to The Second Military Medical School, Professor Li Haiyan, the senior expert of medical ethics in Peking University Third Hospital, and Professor Yao Chen, the senior expert of biostatistics in Peking University First Hospital. They respectively conducted systematic trainings for the great significance, requirements and contents of drug clinical trial inspections, verification points and frequent problems of the multicenter clinical trial, ethical requirements and review points of clinical trial, the scientificalness of clinical trials design for new drugs, and statistical considerations. They especially gave a profound interpretation for the current review situation and requirements from the clinical trial design to the clinical trial process. Wang Qing, the Secretary of GCP Office of our hospital, briefed theverification, inspection and the third party review after the 117 announcement from China Food and Drug Administration (CFDA), and conducted training for thekey elements that clinical trial should focus on strengthening.Yu Zhongguang,the office secretary of the ethics committee in our hospital, carried exchanges and training for matters and common problems of the ethics review and requirements of the national latest biomedical research ethics. 
 
During the conclusion part of the meeting, Vice President Yao Shukun conducted in-depth analysis for the grim situation of theclinical trials, expressed recognition for the active training attitudes of the hospital medical staff, and stressed the need to learn, raise awareness, and understand the true meaning of science. It is expected to strengthen quality control, pay attention to the safety of the trial person, ensure the authenticity and integrity of data, and implement clinical trial accountability, by which to enhance the level of clinical trials in our hospital and make drug, equipment and reagents that with high-quality.
 
The medical staff participating in the training listened attentively to the spirit of the meeting, actively participated in this training. At the end of the training session, GCP training exams were conducted at the conference site. Qualified persons will receive GCP training certificates in the near future. For those who failed to participate in the training for various reasons can learn it from training videos and attend the examinationlater.