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1.
China Pharmacy ; (12): 911-916, 2023.
Article in Chinese | WPRIM | ID: wpr-972259

ABSTRACT

OBJECTIVE To provide scientific basis for establishing the evaluation index system of professional and specialized drug inspectors in China. METHODS Through the method of literature research, group discussions and behavioral event interview, combined with the practice situation of drug inspection at home and abroad, in accordance with the requirements of Chinese laws and regulations and department rules, the evaluation indexes for drug inspectors were extracted and screened. In addition, the Delphi method was used to conduct correspondence with experts in relevant fields so as to determine the evaluation index system of drug inspectors. RESULTS & CONCLUSIONS Finally, 62 experts completed two rounds of anonymous online questionnaires, including 29 experts in the first round and 33 experts in the second round. The questionnaire recovery rates were 96.67% and 94.29% respectively, and the expert authority coefficients were 0.81 and 0.79, indicating a high level of authority among experts. After expert consultation, evaluation index system for professional and specialized drug inspectors had been constructed, including five first-level indexes (personal characteristics, professional knowledge, professional skills, professional behavior and professional ethics) and their corresponding 27 second-level indexes. The average score of the importance of second-level indexes was 4.224- 4.879, the full score ratio was 81.8%-100%, the coefficient of variation was 0.067-0.177, and Kendall’s W was 0.643 (P<0.001). It indicates that this evaluation index system is relatively reliable and is expected to become a management tool for promoting the construction of professional and specialized drug inspector team and ensuring the quality of drug inspection.

2.
Chinese Pharmaceutical Journal ; (24): 338-342, 2019.
Article in Chinese | WPRIM | ID: wpr-858076

ABSTRACT

OBJECTIVE: To explore ways and paths to strengthen team building of China's drug inspectors. METHODS: By analyzing and summarizing the experience and enlightenment of the US FDA's drug inspector team, a series of research are launched considering current situation of drug inspectors, and problems in the China's drug inspector team building are analyzed in depth. RESULTS: It is to provide approaches and methods for the construction of China's drug inspection team. CONCLUSION: The construction of China's drug inspection team should combine both long-term and short-term considerations and solve problems step by step. In the long run, professionalism is the orientation. In the near future, before realization of professionalism, the construction of drug inspectors should focus on specialization and develop full-time and part-time inspectors. At the same time, it is necessary to highlight the professional and technical characteristics of drug inspection, reflect the "high-precision" technical level of drugs, and build a team of professional inspectors at the national and provincial levels. In the consideration of the source of the inspectors, it is recommended that the inspectors to be hired from the third party outside the supervision system, and let local pharmaceutical vocational colleges play great roles to develop potential teams of inspectors.

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