2024-25 Fall - DRAP5101 - Global Pharmaceutical Policy: Rationales and Stakeholders

Course

Description

The course aims to introduce the various regulatory policies and procedures in drug development across multiple jurisdictions globally, such as Food and Drug Administration (FDA), National Medical Products Administration (NMPA), European Medicines Agency (EMA), and International Conference on Harmonization (ICH). Current regulatory policies covering pre-clinical safety, manufacturing, clinical trials, and marketing authorizations will be examined during the drug development process.
Course period1/09/2431/12/24
Course levelPG
Course formatLecture