In order to promote the capacity of inspectorate, and improve the professional skills and comprehensive quality of the inspectors, CFDI held the first experts’ forum on January 28, 2019. Before the lecture, Li Jianming, the deputy director of CFDI, attended and spoke. Director Li emphasized that CFDI in 2019 will be guided by the party group of NMPA, "adhere to one orientation, strengthen two goals, and consolidate the three foundations", and closely unite around the Party Central Committee with General Secretary Xi Jinping as the core, and practice the people-oriented development, work hard, innovate, and write a new chapter in the drug inspection.
Dong Jiangping, the deputy director of CFDI, summarized the holding of the expert forum of CFDI in 2018. In 2018, CFDI held 12 expert forums and invited 15 experts to teach. They invited famous authoritative experts and scholars from the CDE, Chinese Pharmacopoeia Commission, Center for Drug Reevaluation, foreign regulatory agencies, and international and domestic pharmaceutical companies. She lectured the key points for review and approval of chemical drugs, preparation of Chinese Pharmacopoeia, monitoring and evaluation of adverse reactions in China, new measures for FDA drug review and approval, requirements for inspectorate by PIC/S, testing techniques for blood products, the guidance of ICH Q7 and Q9, the inspection points of new technology and pharmaceutical products, and the review and prospects of China's pharmaceutical industry, a total of more than 4,400 person-times intra-industry to listen to the lectures, the expert forum has received positive response and high appraise from the provincial inspectorate. CFDI will continue to maintain this national drug inspector training and communication platform in 2019.
This forum invited Mrs. Huo Xiumin, the former drug evaluation expert of CED of NMPA, to give a lecture. Mrs. Huo was a senior reviewer of CDE. She has been engaged in the CMC review of chemical drugs for more than 20 years and was responsible for drafting a number of technical guidelines such as the Technical Guidelines for the Standardization Process of Chemical Drug Quality Standards . And she is a member of the ICH Q3D expert group. With the theme of “Chemical Drug Research Evaluation”, Mrs. Huo introduced the definition, scope and quality control strategy of chemical drugs, expounded the requirements of pharmaceutical declaration materials, and detailed the pharmaceutical research contents and evaluation points of APIs and preparations. In combination with the characteristics of injections, she emphasized the development and imitation of injections, and analyzed the focus of injections on-site inspection from the perspective of review. Mrs. Huo’s lectures are informative and clear in level. With his deep and solid professional knowledge and in-depth introduction, the participants have a clearer understanding of the identification and control of chemical drug quality risks, and it also provides important guidance in injecting products inspection for inspectors.
The Office of Drug Registration of NMPA, the Chinese Pharmacopoeia Commission, CFDI, the Center of Beijing Drug Certification, the Center of Beijing Drug Review, and 24 provincial drugs inspectorates from the whole country synchronously watching through video system participated in the training, totally more than 470 person participated in the training.
