The first term of senior training class for international inspection abilities of drug inspectors was successfully organized by Department of Human Resources, CFDI and IED of CFDA in Beijing from December 1, 2016 to December 8, 2016, in order to improve international inspection abilities of drug inspectors, broaden their international perspectives, enable them to learn international concept of drug administration and advanced knowledge, and improve professional English level.
Trainees in the training class were 42 national GMP inspectors recommended by 30 provincial drug administration departments nationwide and CFDI and National Institutes for Food and Drug Control of CFDA, who were selected after passing strict English written examination and oral test before class opening, in order to guarantee the training effect. In addition, partial personnel of the drug and cosmetics inspection division and international inspection division of the CFDI also participated in the training.
Deputy Director Sun Jinglin of CFDI and Vice President Liang Lijun of IED participated in the class opening ceremony and made speeches respectively, putting forward study requirements and discipline requirements for the trainees.
The training contents include cGMP regulations and inspection system of USFDA, review regulations and procedure of IND and RND, several guiding principles such as Q8, Q9, Q10 and Q12 of quality management (Q) of ICH. All these mighty and experienced invited instructors have studied abroad or worked for transnational corporations, and most of them have the experience of engaging in long-term drug evaluation and inspection in FDA. In the meantime of explaining the international regulations, these instructors made discussion and research by combining practical cases. In addition, English experts of pharmaceutical specialty were invited to explain the methods of learning English.
It was the first time for these inspectors to take an "All-in-English" class during training, as they shall not only listen to the English class, but also interact with others, make discussion and complete homework, test and examination in English. It arranged a test for each learning unit, and a strict examination for completion of the training. These trainees highly praised the innovative "All-in-English" training method, and expressed that they not only obtained a lot in international regulations and knowledge and professional English, but also recognized their language disparities through the challenge of “All-in-English” teaching. As a result, they would continuously strive for improvement at work.
For applying their knowledge in practice, these trainees participated in the "double-random" tracking inspection on drug manufacturers organized by the CFDI after study in the training class.
