| Drug safety is a major basic livelihood and public safety issue.All countries in the world attach great importance to drug safety.China’s drug regulatory agencies have been reformed,and the regulatory system has gradually improved,but the situation of drug safety hazards and drug-related crimes is still serious and complex,the poison capsule drug incident,the Changsheng biological vaccine incident and other fake drugs and poison events have caused widespread concern.At the same time with the rapid development of China’s socialist market economy,the pharmaceutical industry is growing,the emergence of new products and new technologies has led to a mismatch between regulatory resources and regulatory objects and other issues,it can be seen that the increasingly complex regulatory situation to the drug regulatory authorities under great pressure,which also put forward higher requirements for the quality of drug inspection team capabilities.At present,China’s professional and specialized drug inspection team is in the construction period,the lack of professional team capacity,the uneven level of supervision and other issues are more prominent,so to enhance the competence of drug inspectors has become an urgent concern.Based on the Mc Clelland competency theory model,this paper firstly compares the competency elements of drug inspectors through literature analysis,job analysis and key event interview method to form a pool of competency indicators,and then forms a questionnaire on the competency elements of drug inspectors in L province after two rounds of expert consultation.Finally,the model of 19 competency factors under 5 dimensions was constructed and validated.Finally,based on the constructed competency model and combined with the actual team management in L province,we propose the application of selection system,training system and evaluation mechanism,in order to provide reference for the improvement of drug inspectors’ inspection ability and level in L province. |
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