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 Seventh Experts’ Forum was successfully held at CFDI according to the work plan of CFDI Academic Committee on August 18, 2017. Dr. He Ruyi, the Chief Scientist from the Center for Drug Evaluation, CFDA was invited in this expert forum, and give a lecture on “Evolution of US FDA Regulatory Policy" and "Clinical Trial Application and Related Special Evaluation and Approval Policy”.

Director Ding Jianhua from CFDI attended the forum and gave a speech. Director Ding emphasized the importance of training and learning to inspectors and pointed out that during the six phases of expert forums which have been held, the participants learned new knowledge through each forum and enhanced the comprehensive ability of all aspects, which will benefit the professional and specialized development of inspectors in the future.

Dr. He currently serves as the Chief Scientist from the Center for Drug Evaluation of CFDA (CDE). Combining with the serious drug events happened in last century, Dr. He focused on the interpretation about the whole process of the formulation, establishment, development and perfection of the FDA regulations and particularly introduced the publishing background and main contents of several important bills in the first part of the lecture. In the second part of the lecture, Dr. He introduced the review system of the clinical trial application for investigational new drug (IND) in the United States, including the review procedure, requirements and key contents. In combination with the typical cases, Dr. He introduced the techniques for inspecting the reliability of clinical trial data and the cautious attitude that the inspectors should hold. From Dr. He's lecture, inspectors have extended their expertise, broadened their international perspective, strengthened the regulatory concepts and enhanced the sense of responsibility, and it has an important reference value for our inspection and verification work.

Over 360 people from the Department of CFDI, the Center for Drug Certification of Beijing Food and Drug Administration, and 15 provincial drug inspectorate from the whole country synchronously watching through video system participated in the training.