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 forth experts’ forum on May 18, 2018. At this forum, Dr. Chen Qinghua, a reviewer of the Department of Biological Products Pharmacy of the Center for Drug Evaluation, was invited to give a lecture on “Vaccine pharmacy review and on-site inspection”.

Professor Chen Qinghua currently serves as the reviewer of the Department of Biological Product Pharmacy of the Center for Drug Evaluation. She is mainly engaged in the review of vaccines. She worked for the National Institute of Bioscience and Biotechnology of Sinopharm for 10 years and participated in the post-marketing evaluation of influenza A vaccine, registration and clinical research of EV71 inactivated vaccine, etc.

Professor Chen Qinghua introduced the definition of biological products, the classification and development of vaccines, the process flow and quality control requirements for vaccines, and explained the focus of vaccine evaluation from the aspects of raw materials, process, quality research, etc., and in combination with review cases, she explained vaccine process validation and comparability study in detail. Ms. Chen’s lecture provided an insightful understanding of the key points and technical requirements for the review of vaccines and provided a reference for the relevant inspection of vaccines.

The Office of Drug and Cosmetics Registration, the Chinese Pharmacopoeia Commission, CFDI, the Center of Beijing Drug Review, and 23 provincial drugs inspectorates from the whole country synchronously watching through video system participated in the training, totally 350 person participated in the training.