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2023-24 Spring - BIEN4110 - Regulatory Affairs in the Healthcare Industry

Course

Description

Instructor(s)/Supervisor(s)/Coordinator(s): Wing Kit Donald CHONG
This course aims to introduce basic concepts of regulatory science, while familiarizing students with product development, manufacturing, medical and engineering operations, and quality control / quality assurance processes in the pharmaceutical and medical device industry. Students will also be introduced to the associated regulatory requirements, with an emphasis on Hong Kong, Great Bay Area, China and beyond, in topics such as Good Manufacturing Practice (GMP), pharmaceutical product registration, pharmacovigilance, and clinical trials.
Course period1/02/2430/06/24
Course levelUG
Course formatLecture