Description
Instructor(s)/Supervisor(s)/Coordinator(s): Sunny TAM, Xin DUThe 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.