In order to implement the requirements of “carrying out skills training around professional inspector team construction”, to promote the capacity of inspectorate, and improve the professional skills and comprehensive quality of the inspectors, CFDI held the seventh experts’ forum on August 16. At this forum, Yang Wei, the director of the Center for Drug Reevaluation of the former CFDA, was invited to give a lecture on “A Brief Introduction on the Monitoring and Evaluation of National Adverse Drug Reaction”.
Director Yang Wei, first introduced the basis of big three working which are laws and regulations, monitoring system and information network in our national adverse drug reaction monitoring and reevaluation. And then, he explained the present situation and the development of adverse drug reaction monitoring and reevaluation through four aspects on the quantity lay equal stress on quality, monitoring and reevaluation develop simultaneously, active and passive complementary and exchanges and cooperation all win. Finally he introduced the future direction of national adverse drug reaction monitoring and reevaluation through the four aspects on direct report system of drug marketing authorization holder, transformation ICH guidelines, in-depth research and information disclosure. Director Yang presented the work of national adverse drug reaction monitoring and reevaluation with detailed data and examples, which made benefit a lot for the participants and provided an important reference for inspectors to carry out their work.
Director Yang Wei served as the director of the drug administration office, the director of drug registration division, the director of drug safety division in Jilin province, the deputy director and audit commissioners of the office of drug registration of the former CFDA. He served as the director of the Center for Food and Drug Inspection of the former CFDA from October, 2012 to May, 2015 and he has high drug regulatory theory level and rich practical experience.
The CDE, CFDI of the former CFDA, the Center of Beijing Drug Certification, the Center of Beijing Drug Review, and 21 provincial drugs inspectorates from the whole country synchronously watching through video system participated in the training, totally 380 person participated in the training.
