In order to promote the capacity of inspectorate, and improve the professional skills and comprehensive quality of the inspectors, CFDI held the forth experts’ forum on December 4, 2020. Leng Xiaomei, professor of Peking Union Medical College Hospital, was invited to give a lecture on “Application of biological agents and biological analogues in rheumatic diseases”.
Professor Leng introduced the concept of biological agents and rheumatic disease and the current situation of the related treatment products, detailed explained the TNF α , IL - 6, CTLA - 4 - Ig fusion protein, IL - 17 inhibitors, Belimumab monoclonal antibody and so on 5 kinds of biological agents for targeting therapy rheumatoid disease. She compared the biological similar medicines and biological original development preparation in the aspects of molecular structure, manufacturing process, treatment efficacy, drug safety, patient acceptance, special populations and so on in treatment of the rheumatic diseases. Professor Leng's lecture was comprehensive and rich in content, with profound explanation in simple words and strong enlightening, which expanded the knowledge reserve of inspectors and provided references for inspectors to carry out relevant inspections.
Professor Leng Xiaomei is the chief physician of the Department of Rheumatology, Peking Union Medical College Hospital, and an expert of drug GCP inspection of National Medicine Product Administration. She has rich experience in the field of medical practice, academic research and drug inspection of rheumatic diseases.
CFDI and 22 provincial drugs inspectorates synchronously watching through video system participated in the training, totally more than 300 person participated in the training.