In order to implement the drug registration inspection after the carrying out of the new Measures on Drug Registration Administration , the second joint inspection training course for drug registration was held by CFDI of NMPA in Nanjing of Jiangsu province on December 9 to 10, 2020.
This course mainly focuses on the implementation of pharmaceutical research and production site verification after the implementation of the new Measures for the Administration of Drug Registration . Jiang Wei, vice director of drug administration of Jiangsu province, give an opening speech, Dong Jiangping, deputy director of CFDI, give the first lecture titled "drug registration inspection work ideas under the new regulatory framework", Liu Xiaogang, the section chief of drug supervision office of NMPA explained the pharmaceutical records and data management requirements carried out from December 1. Other training contents will be explained by key inspectors of the CFDI, mainly including inspection procedures, inspection key points and judgment principles, inspection implementation strategies, inspection plan formulation key points and inspection report writing considerations, overall requirements and matters to note during inspection organization, etc. In addition, combined with the inspector's high pressure and intensity, the conference also invited Shen Yongjian, associate professor of Nanjing University of Chinese Medicine, to explain the content of "mental health elements and Mental health training", so as to provide the inspectors attending the conference with ways to reduce pressure.
Participants said that the course closely followed the work requirements with the implementation of the new law, the content is comprehensive and enrichment, the teachers are rich experience, the benefits are very rich.
Nearly 280 national and provincial inspectors from 12 provinces and cities including Beijing, Tianjin, Hebei, Shanxi, Liaoning, Jilin, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui and Shandong participated in the training, which was strongly supported by Jiangsu Food and Drug Administration.
The third Joint Inspection Training Course for Drug Registration will be held in Guangzhou this month.
