Regulatory Training Programme Course 6
November 23, 2017
The sixth course of the Regulatory Training Programme, that is jointly organized by the University of Hong Kong and HKAPI, was attended by 75 members and academics.
The four-part lecture focused on clinical trial from a regulatory affairs perspective. Mr. Henry Yau (Managing Director of the HKU Clinical Trial Centre), Ms. Kim Lee (Lead of the HKAPI Clinical Trial Taskforce), Mr. Vincent Chiang (Senior Pharmacist (Drug Import and Export) of the Drug Office) and Mr. Clement Ngai (partner of Baker & McKenzie Shanghai) spoke on such topics as research and regulatory development of clinical trials in Hong Kong and the Mainland China, gave practical case studies on how to submit NCE application using phase 2B clinical data, as well as important notes surrounding the application for Certificate for Clinical Trial/Medicinal Test in Hong Kong.