Construction of Post Competency Evaluation Index System for Drug Registration Specialist / 中国药房

ABSTRACT

OBJECTIVE：To esta blish a sc ientific and objective post competency evaluation index system for the drug registration specialist. METHODS ：By searching the competency model literature of drug registration and registration related documents，combined with Spencer ’s Competency Dictionary and Hay ’s Competency Dictionary ，post competency evaluation index system for drug registration specialist was formulated preliminarily. Through two rounds of Delphi expert consultation ，experts in related fields of drug registration were consulted by letter ，the evaluation indexes were screnned and revised ，and the weight of the indexes was calculated by using the superior order diagram method. Based on questionnaire survey ，232 drug registration personnel were selected as research objects ，and then exploratory factor analysis ，confirmatory factor analysis and internal consistency reliability analysis were used to test the constructed evaluation index system. RESULTS ：The post competency evaluation system of drug registration specialist covered 4 core dimensions （registered professional ability ，relationship management ability ，professional development ability ，personal comprehensive quality ），11 sub-scales，and 41 measurement items ；the weight of the index was confirmed. The establishment process of the evaluation system showed that the expert consultation had high enthusiasm and good coordination；exploratory factor analysis and confirmatory factor analysis had proved the scientific rationality of the index system. CONCLUSIONS：The post competency evaluation index system for drug registration specialist is comprehensive ，integrated and scientific，can provide reference for evaluation and management of the drug registration specialist practice.