Center for Food and Drug Inspection (CFDI), CFDA successfully held the 5th training class for drug clinical trial data inspectors in Beijing from December 7 to 9, 2016.

Ding Jianhua, the Director of CFDI, attended the opening ceremony and delivered a speech, which emphasized the importance of clinical trial data inspection and inspector training work, and raised requests to the students participated in the training. Six domestic senior experts of drug clinical trial and GCP inspectors made detailed interpretation and analysis in terms of the trial scheme design of GCP and statistical requirements, data verification focus, standards, inspection key points, methods and technologies of BE and I-III phases of clinical trials, and shared their experience with the students. The responsible person of the Division of Research Inspection and Administrative Office of CFDI introduced the procedures, requirements and integrity of the discipline of the data verification.

More than 130 students from the provincial drug regulatory authorities, inspectorates and the clinical trial and the representatives of the Division of Research Inspection and the Division of International Inspection, CFDI participated in the training.

Through this training, the participants comprehensively and clearly understood the inspection standards, key points and requirements of clinical trial data inspection, and the experts shared their experiences in GCP site inspection accumulated over the years, which achieve the desired results of the training, the students reacted strongly, and said that they have abundant harvests.