17 October 2025
Event Date(s)/Period(s)
17 Oct 2025
Organised by:
- HKU Clinical Trials Centre
- DIA China
The HKU Clinical Trials Centre, in collaboration with DIA China, hosted a one-day workshop designed to transform regulatory insights into global drug development strategies. The programme explored the logic of the world's most influential drug approval systems, shifting the focus from simple compliance to high-level strategic planning.
The session featured authoritative perspectives from Dr Li Zili and Dr Zou Limin, former reviewers from the U.S. FDA and China NMPA, respectively. They were joined by Dr Antonio Barra Torres, a former President-Director of ANVISA, Brazil's drug regulatory authority, providing a precious tri-continental look at how agencies weigh clinical evidence and assess innovative science. Through comparative case studies, participants gained practical insights into specific clinical reviewer expectations and strategic factors that influence new drug applications across jurisdictions. By demystifying the ‘regulator's mindset’, the workshop provided researchers and industry professionals with hints to better navigate the complex journey from laboratory discovery to international market authorisation.
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