국내 의약품 규제업무(RA) 전문인력 양성에 필요한 역량과 지식에 대한 산업체의 교육요구도 분석

Abstract

Education in regulatory affairs for pharmaceuticals is crucial in order to equip experts with the necessarycompetency and knowledge to navigate the legal and scientific regulations involved in managing the drug lifecycle. Inorder to develop the framework which ensures the competency and knowledge, 6 competency requirements and 48knowledge items were derived from the previous studies. These were then reviewed by 16 experts in three rounds of aDelphi process to assess their validity and reliability in terms of both present and required levels. The Wilcoxon SignedRanked Test was subsequently conducted to determine whether there was a statistically significant difference between therequired and present levels. and Borich's educational needs and the Locus for Focus Model were used to confirm the 12knowledge and 1 competency areas that were identified as having high priority. Based on the findings of this study, asystematic educational program focusing on the necessary competencies and knowledge required for professionals inregulatory affairs of pharmaceuticals should be developed and established.