The advent of biotherapeutics and biosimilars highlighted the need for regulatory affairs to accommodate the 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, the defining differences from traditional pharmaceuticals and generics, and the regulatory processes for managing these health products. There is a focus on post-market activities which serve as the main guard for ensuring the safe use of these innovations.
- Explain the principles underlying the current regulatory guidelines as applicable to
the development and evaluation of biologics.
- Identify the quality and CMC attributes critical for characterization of
biotherapeutics and comparability of biosimilars.
- Describe the key regulatory requirements in the nonclinical and clinical
development of biosimilars and evaluate the adequacy of data as applicable to
marketing authorization application.
- Identify the common areas of concerns in the regulation of biotherapeutics and
biosimilars, in the context of pharmacovigilance and product life cycle
- Explain the importance of the recent trends in biologics that play an important role
in the access of these products to patients.