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 ninth experts’ forum on September 17. At this forum, Dr. Thomas Schultz from Janssen Pharmaceutical Companies of Johnson and Johnson and Dr. Li Lei from Eli Lilly and Company were invited to give a lecture on “Quality Risk Management”.

The subject of Dr. Thomas Schultz's lecture was the overview of quality risk management of ICH Q9, which explained in detail the history of the generation of ICH Q9 guiding principles, the main elements contained in the Q9 guiding principles, and the work needed to be carried out in the implementation and application of the Q9 guiding principles. Dr. Li Lei introduced the quality risk management system, concept, thinking and method in the process of drug development. He explained the application practice of the method based on science and risk in different stages of drug process prescription design, clinical trial and commercial production through the case of "bispecific antibody development". The lectures of the two experts gave participants an in-depth understanding of the ICH Q9 guidelines, enhanced the inspectors' awareness of quality risk management, and expanded their knowledge of quality risk management.

CFDI, the Center of Beijing Drug Certification, the Center of Beijing Drug Review and 22 provincial drugs inspectorates from the whole country synchronously watching through video system participated in the training, totally 320 person participated in the training.