智改数转背景下，基于CDIO教学模式的《药品数据管理实务》课程开发与实践

Development and Practice of a CDIO-Based Course in Pharmaceutical Data Management in the Context of Intelligent Transformation and Digitalization

摘要: 在全球第四次工业革命和“智改数转”战略驱动下，我国医药产业正加速向智能化、数字化转型升级，面临人才能力结构与产业现实严重脱节的挑战。为此，本研究基于CDIO (构思–设计–实施–运作)工程教育模式，开发并实践了《药品数据管理实务》课程。通过构建涵盖中药、化学药及无菌制剂的“数字孪生”教学项目，引导学生实际操作LIMS、MES、DCS等生产与管理系统，培养其数据治理、技术应用及合规决策等综合能力，旨在弥合“人才鸿沟”，为医药产业数字化转型提供具备工程思维与创新能力的复合型技术技能人才，并为同类课程改革提供可借鉴的实践路径。

Abstract: Driven by the global Fourth Industrial Revolution and China’s “Intelligent Transformation and Digitalization” strategy, the pharmaceutical industry is accelerating its transition toward intelligent and digital transformation. However, a significant gap persists between the current talent capabilities and industrial demands. To address this challenge, this study developed and implemented the Pharmaceutical Data Management Practice course based on the CDIO (Conceive-Design-Implement-Operate) engineering education model. By constructing “digital twin” teaching projects covering traditional Chinese medicines, chemical drugs, and sterile preparations, students were guided to practically operate production and management systems such as LIMS, MES, and DCS. The course aims to cultivate comprehensive competencies in data governance, technology application, and regulatory compliance, thereby bridging the “talent gap”. It seeks to supply the pharmaceutical industry’s digital transformation with compound technical talents possessing engineering thinking and innovative capabilities, while also providing a replicable practice pathway for similar curriculum reforms.