Required Courses：必修课程 DRAP 5001 Introduction to Drug Regulatory Science with Quality by Design：介绍药物监管科学与质量设计 Drugs, Biologics and Medical Devices Development: Leadership Role：药物、生物制剂和医疗器械开发: 领导角色 Safety of Medicines: From Non-clinical Development to Pharmacovigilance：药物安全性: 从非临床开发到药物警戒 China/USA/EU Regulatory Environment: Procedures and Applications：中国/美国/欧盟监管环境: 程序和应用 Elective Courses：选修课程 Business Operations of Biotechnology：生物技术业务 Biomarkers and Medical Devices：生物标志物和医疗器械 Drug Discovery and Development：药物发现和开发 Nutraceuticals and Transgenic Products：营养保健品和转基因产品 Global Pharmaceutical Policy: Rationales and Stakeholders：全球药品政策: 基本原理和利益相关者 Biopharmaceuticals: Quality Development and Documentation：生物制药: 质量开发和文档 Big Data, Artificial Intelligence and Machine Learning in Drug Safety：药物安全中的大数据、人工智能和机器学习 Digital Health：数字健康 Market Access for Pharmaceutical Products: Trends and Challenges：医药产品的市场准入: 趋势和挑战 Clinical Pharmacology and Biostatistics：临床药理学和生物统计学 Industrial Internship：工业实习 Regulatory Affairs Capstone Project：法规事务Capstone项目 Product Development Management：产品开发管理