The Seventh Experts' Forum Was Successfully Held at CFDI in 2019
In order 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 2, 2019. Dr. Ma Jing, from National Shanghai Center for New Drug Safety Evaluation and Research, was invited to give a lecture on “Risk control in the evaluation and inspection of cell therapy varieties”.
Dr. Ma systematically introduced the current situation of cell therapy products, introduced relevant laws and regulations at home and abroad, explained in detail the key points and risk factors of cell therapy pharmaceutical research, non-clinical research and clinical research, and shared the key points of on-site inspection of cell therapy varieties. Dr. Ma's lecture was rich in content and detailed in cases, which deepened inspectors' understanding of cell therapy products and provided important references for relevant inspections.
Dr. Ma owns more than 30 years’ experience in the pharmacology, drug toxicology teaching and scientific research, a former researcher at National Shanghai Center for New Drug Safety Evaluation and Research, the general counsel of Shanghai InnoStar Biotech, LTD., the director of drug toxicology professional committee of Chinese Pharmacological Society, concurrently hold the position of the National Medical Products Administration drug evaluation and GLP experts.
The Office of Drug Registration of NMPA, CFDI, the Center of Beijing Drug Certification, the Center of Beijing Drug Evaluation and 23 provincial drugs inspectorates from the whole country synchronously watching through video system participated in the training, totally more than 350 person participated in the training.