The inaugural “Regulatory Functional Training,” a core module of the “CREATInG Initiative” (China Regulatory Excellence and Training for In-vitro Diagnostics Global Initiative), successfully concluded at Duke Kunshan University from November 10th to 12th. This marks the third major activity under the initiative, following an international roundtable and an executive workshop.
The intensive three-day training brought together key regulatory affairs professionals from leading In Vitro Diagnostics (IVD) companies in China and South Korea. Taught by a distinguished faculty of top global regulatory experts and industrial consultants with facilitation by the Duke-NUS faculty members, Asst Prof James Leong and Asst Prof Wei Chuen Tan-Koi, using the “Team-based pedagogy”, the program served as a vital bridge, empowering Asian IVD innovations to reach global markets.
The training curriculum delved into international market regulatory frameworks and offered hands-on training in regulatory skills. Topics included total product lifecycle management, risk classification, and market access strategies for IVD products. Highlights of the training featured the global markets’ regulatory landscapes and regulatory requirements of the US FDA, the European Union, and ASEAN as well as reliance mechanisms for facilitating IVD approvals. Mr. Andrew Ho, Co-founder of DH RegSys, offered clear strategic guidance on navigating international regulatory shifts, especially the latest updates to the EU’s IVDR.
Other topics included Singapore’s IVD Registration Process by Ms. Shuhui Liu from the Health Sciences Authority (HSA) of Singapore, the Role of academia in supporting global IVD clinical development by Professor Yao Chen from Peking University First Hospital, and the WHO prequalification processes of IVDs.
A significant practical component was led by Ms. Tan Hwee Ee, Founder of DH RegSys, who brought over 30 years of experience in quality assurance and regulatory affairs. Through case studies, she guided participants in practicing risk assessment and control processes within IVD lifecycle management. Furthermore, an interactive “Asset Building” for IVD product registration exercise allowed attendees to apply their newfound knowledge, solidifying their understanding of regulatory requirements through peer sharing and expert feedback.
Jointly launched by the Centre of Regulatory Excellence (CoRE) of Duke-NUS Medical School and Duke Kunshan University, the CREATInG Initiative aims to enhance global market access capabilities. The program convenes global experts and industry leaders to strengthen regulatory and market access for affordable IVD solutions in low- and middle-income countries through international conferences, executive training, and capacity-building programs.
The resounding success of this first Regulatory Functional Training session lays a solid foundation for future programs. The CREATInG Initiative remains committed to leveraging global expertise and regulatory networks, effectively accelerating the IVD companies’ global journey and paving ways for the access of affordable IVD solutions in low- and middle-income countries.
2026 Regulatory Functional Training
The CREATInG Initiative plans to launch its second core training session on IVD ISO 13485 Quality Management Systems, from May 21 to 23, 2026. This session will focus on key topics, including the implementation of ISO 13485 standards, optimizing risk-based quality management systems, and preparing for local inspections. The training will be held at Duke Kunshan University, employing the Duke-NUS Team-based Learning (TBL) teaching model. Conducted as a small-group-based and closed-door workshop, the training will facilitate the exchange of experiences and the sharing of practical knowledge among participants. (For more information, please contact Cici Yan mengxi.yan@dukekunshan.edu.cn )
About the CREATInG Initiative
Launched in 2024, the CREATInG Initiative is a joint effort of Duke-NUS Medical School’s Centre of Regulatory Excellence (CoRE) and Duke Kunshan University. The program convenes global experts and industry leaders to strengthen regulatory and market access for affordable IVD solutions in low- and middle-income countries through international conferences, executive training, and capacity-building programs. Learn more: https://www.duke-nus.edu.sg/core/think-tank/gates-core-and-duke-kunshan-regulatory-strengthening-project
