In order to implement the requirements of “carrying out skills training around professional inspector team construction” of leading Party group of the CFDA, to promote the capacity of inspectorate, and improve the professional skills and comprehensive quality of the inspectors, the Fifth Experts’ Forum of CFDI was held successfully according to the work plan of CFDI Academic Committee on June 16, 2017. Dr. Wang Gang, Chief Scientist of Center for Drug Evaluation of CFDA was invited in this expert forum, and made the lecture entitled “Update on FDA’s Drug Inspection program”. Director Ding Jianhua of CFDI hosted the meeting.

As the Chief Scientist of Center for Drug Evaluation (CDE), Dr. Wang is mainly responsible for establishing, implementing and improving the work in terms of conformance and inspection related to drug evaluation of CDE. Before joining CDE, Dr. Wang had worked for nearly 12 years in FDA. He has rich practical experience in biological product evaluation and international GMP conformance inspection. It is recognized that Dr. Wang is an expert in the field of biological medicine evaluation and inspection at home and abroad.

In this Experts’ Forum, Dr. Wang Gang mainly interpreted the advanced concept of new drug pre-approval inspection (PAI) and inspection system of FDA, including history, inspection program, result handling and other aspects, and briefly introduced two enforcement actions of FDA in the matter of drug inspection, including program alignment in the Office of Regulatory Affairs and mutual recognition agreement on international inspections. The lecture was comprehensive, detailed, informative, and has great reference value for national drug inspection.

Over 350 representatives of the Department of Drug and Cosmetics Registration, CFDI, Beijing Center for Certification of Drug and 16 provincial drug inspectorate from the whole country synchronously watching through video system participated in the training.