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 fifth experts’ forum on June 7, 2018. At this forum, Dr. Robert Tribe, the GMP expert of International cooperation Project, was invited to give a lecture on “The requirements of PIC/S for drug inspectorates”.

Robert Tribe who is from Australia is experienced on international agencies working. He has held the post of the director of drug inspectorates of Therapeutic Goods Administration (TGA) in Australia for many years. He was hold the former chairman of PIC/S from 2000 to 2001.

Robert introduced the developing history, operation mode, GMP guideline and inspector training program of PIC/S comprehensively, explained the history of quality system documents of PIC/S and the requirements of PIC/S for drug inspectorates on quality system, and shared the design of quality manual of TGA. Robert dwelled on the requirements of PIC/S for drug inspection combining his work experience and taking inspection program for example. The lecture of Dr. Robert Tribe is rich and detailed, so the conferee have a comprehensively understanding about PIC/S and the requirements of PIC/S for drug inspectorates and inspection work, and it is provided a significantly reference for promoting the construction of drug inspectorates of our country and improving the inspection ability comprehensively.

The Office of Drug and Cosmetics Registration, the Office of Drug and Cosmetics supervision, the Chinese Pharmacopoeia Commission, the Center of Drug Review, CFDI, the Center of Beijing Drug Certification and 22 provincial drugs inspectorates from the whole country synchronously watching through video system participated in the training, totally 380 person participated in the training.