4 Units
The advent of biotherapeutics and biosimilars highlighted the need for regulatory affairs to accommodate the rapidly evolving medical sciences, necessitating timely revisions in policies, processes and the technical knowledge in managing these new innovations and facilitating access to meet medical needs.
This course provides the background to the rise of these biologicals in healthcare, and the defining differences from traditional pharmaceuticals and generics. There is a focus on post-market activities which serve as the main guards for ensuring the safe use of these products.