Aims and Fit of Module

To provide students with fundamental knowledge in pharmaceutical analysis and analytical instrumentation involved.

Learning outcomes

A Demonstrate a critical understanding of regulatory affairs, both NMPA and FDA B Evaluate potential drug products from preclinical trials, to clinical trial (Phases I to III), IND and NDA filing, plus Phase IV. C Fully understand the complete process from lab to bed (GMP, CMC, contamination, PAT and validation).

Method of teaching and learning

Course content will be delivered by standard lectures and two field trips to local R&D pharma or CRO for preclinical services.