In order to implement the requirements “carrying out skills training around professional inspector team construction ”of leading Party group of the CFDA, promote capacity of inspectorate, and continuously improve professional skill and comprehensive quality of the inspectors, Academic Committee of the CFDI will held “Experts’ Forum” monthly under the support of the leaders of the CFDI, and invite domestic and foreign senior experts to explain international drugs research & development, review, approval, inspection, test, detection and other relevant comprehensive knowledge. Besides requiring the inspectors from the CFDI to participate in it, the forum will invite all provincial inspectorates to share the lecture content in the way of video conference.

The 1 ^st “Experts’ Forum” was successfully held at the CFDI on February 28, 2017. Firstly, the CFDI’s Deputy Director Dong Jiangping made a speech. Director Dong emphasized significance and starting point of holding of the forum, and introduced the way of holding of the forum. Then, Professor Chen Zhen from School of Pharmaceutical Sciences at Zhengzhou University and Senior Engineer Chen Huiping from the CFDI respectively gave an explanation regarding the two titles including “Q part of ICH M4 guidelines” and “skills of an effective lecture”.

Professor Chen Zhen firstly briefly introduced establishment background and relevant work of ICH, and then emphatically introduced the Q part of ICH M4 guidelines, namely, requirements of drug registration on CTD of APIs and reagents. Professor Chen not only introduced the requirements of international regulations, but also combined them with relevant requirements on CTD in our country. His lecture showed not only forward looking of the international standard but also practicability of the domestic requirements.

Senior Engineer Chen Huiping explained the methods and skills to delivery an effective lecture at a seminar or on a training course to the representatives present at the forum by combining her experience in undertaking the task of teaching as a drug inspector for several years. The knowledge she taught was very instructive to the inspectors undertaking not only the task of inspection but also the task of teaching.

More than 50 staffs from the CFDI and 11 representatives from Beijing Drug Certification Center and Beijing Medical Device Evaluation Center participated in the lecture. At the same time, 13 provincial inspectorate including Shanghai Drug Evaluation and Inspection Center watched it through video system, and gave a positive feedback.