Activities
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10/30/2025
USC-NTU Seminar on Regulatory Science
本平台於2025年10月29日舉辦「USC-NTU Seminar on Regulatory Science」，旨在深化臺大與美國南加州大學 (USC) 之學術夥伴關係，並促進法規科學領域之實務經驗交流。本次活動由USC Department of Regulatory and Quality Sciences之Chair and Associate Professor, Dr. Eunjoo Pacifici與Regulatory Consulting Center Director and Assistant Professor, Dr. C. Benson Kuo兩位老師，帶領九位法規科學博士生 (Doctoral Candidates) 來訪，與本院師生進行深度對談；透過此一交流平台，不僅強化了兩校在法規科學教育課程與人才培育上的實質連結，更展現了學術單位推動國際合作之積極作為。
會議議題緊扣當前國際醫藥法規之最新趨勢，廣泛涵蓋藥物開發之動物試驗替代方案、人工智慧與機器學習於醫療器材之應用風險管理，以及再生醫療療法之加速審查途徑等前瞻領域。透過分享美國業界的實務觀點與最新法規思維，有效提升了與會師生對國際法規科學發展的視野，並為未來持續的學術互動奠定良好基礎。詳細議程內容請參見下方。
活動剪影
本平台於2025年10月29日舉辦「USC-NTU Seminar on Regulatory Science」，旨在深化臺大與美國南加州大學 (USC) 之學術夥伴關係，並促進法規科學領域之實務經驗交流。本次活動由USC Department of Regulatory and Quality Sciences之Chair and Associate Professor, Dr. Eunjoo Pacifici與Regulatory Consulting Center Director and Assistant Professor, Dr. C. Benson Kuo兩位老師，帶領九位法規科學博士生 (Doctoral Candidates) 來訪，與本院師生進行深度對談；透過此一交流平台，不僅強化了兩校在法規科學教育課程與人才培育上的實質連結，更展現了學術單位推動國際合作之積極作為。
會議議題緊扣當前國際醫藥法規之最新趨勢，廣泛涵蓋藥物開發之動物試驗替代方案、人工智慧與機器學習於醫療器材之應用風險管理，以及再生醫療療法之加速審查途徑等前瞻領域。透過分享美國業界的實務觀點與最新法規思維，有效提升了與會師生對國際法規科學發展的視野，並為未來持續的學術互動奠定良好基礎。詳細議程內容請參見下方。
| Time | Topic | Speaker |
| 10:00-10:15 | Opening Remarks | Churn-Shiouh Gau, PhD Adjunct Professor/Principal Investigator of the PRIRS, School of Pharmacy, College of Medicine, NTU Eunjoo Pacifici, PharmD, PhD Chair and Associate Professor Department of Regulatory and Quality Sciences Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, USC |
| 10:15-10:30 | NTU Regulatory Science: Program Updates and Research Highlights | Lin-Chau Chang, PhD Associate Professor/Co-Principal Investigator of the PRIRS, Director of the Preparatory Office for the Master's Degree Program in Regulatory Science for Medicine, School of Pharmacy, College of Medicine, NTU |
| 10:30-11:00 | Innovative Approaches to Drug Development: FDA's Move to Phase Out Animal Testing and Its Global Regulatory Impact | Erika Fernandez, BPharm, MSc, RAC DRSc Doctoral Student, USC Associate Director of Global Regulatory Affairs at Gilead Sciences |
| 11:00-11:30 | Balancing Innovation and Safety: A Comprehensive Risk-Management Framework for AI/ML-Enabled Medical Devices | Nicholas Sarif DRSc Doctoral Student, USC Principal at Genentech |
| 11:30-12:00 | The RMAT Designation Accelerates the Development of Regenerative Medicine Therapies in the U.S. | Weiwei (Vivien) Hua, MBA, MS DRSc Doctoral Student, USC Vice President of CMC at Humphries Pharmaceutical Consulting |
| 12:00-13:00 | Lunch and Discussion |
Speech photos
活動剪影