The curriculum of this Program is structured around the practical operational framework of regulatory science. It emphasizes a science-based approach that integrates scientific evidence with regulatory formulation, policy decision-making, and practical implementation. The curriculum is systematically designed to align with students’ learning progression, beginning with foundational core courses, advancing to interdisciplinary coursework, and extending to research-oriented seminars and thesis training. Internship opportunities that integrate industry, government, and academia are also incorporated, enabling students to establish a clear linkage between theory and practice.
In terms of course content, required courses begin with regulatory science principles and institutional frameworks established by stringent regulatory authorities. Topics encompass regulatory issues related to drugs, medical devices, and advanced therapies, followed by critical examination of Taiwan’s existing regulatory framework and institutional characteristics. Course discussions span scientific evaluation, regulatory practice, legal foundations, intellectual property, and patent strategy, guiding students to understand how scientific evidence is translated into regulatory decision-making.
To address the rapid advancement of biomedical innovation, the Program places particular emphasis on advanced therapies (such as cell and gene therapies) and artificial intelligence (AI)-assisted drugs and medical devices. Through international case analyses, students explore global development trends while examining Taiwan’s opportunities and challenges. Course content is continuously reviewed and updated in response to evolving developments and practical needs in the field of regulatory science.
In addition to lecture-based instruction, the Program extensively adopts case-based discussions, role-playing exercises, and group project presentations to simulate real-world regulatory communication and decision-making scenarios. These approaches are designed to enhance interaction, communication, and critical thinking skills among students from diverse academic backgrounds. Elective courses related to industry, government, and academia are also offered, allowing students to tailor their training according to individual career development paths and to further strengthen their professional expertise. Through this flexible and practice-oriented curriculum, the Program aims to cultivate regulatory science professionals with global perspectives, forward-looking thinking, and leadership capabilities.