In view of the ongoing situation for COVID19 and the local measures to further contain the spread, the following modules will be conducted entirely online: GMS5103 Regulation of Cell, Tissue and Gene Therapies (22-26 June 2020) and GMS5105 Generic Medicines (13-17 July 2020).
*Tentative dates of all the modules workshop. Dates will be confirmed at the beginning of each semester
This fundamental module provides the understanding of the contribution of the various stakeholders, functions and guidelines that shape the regulatory environment and impact the healthcare management scene.
This module provides the background to the rise of these biologicals in healthcare, and the defining differences from traditional pharmaceuticals and generics.
This module provides the foundation in understanding the regulatory science behind the development, manufacturing and control of pharmaceuticals, including the global guidances that shape the regulatory processes.
Within this module, the principles, frameworks and processes for pharmacovigilance will be introduced. Various platforms and partnerships among regulatory stakeholders for ensuring adequate and quality pharmacovigilance data will be also covered.
This module provides the understanding for the unique requirements of clinical trials and clinical data meant to support regulatory evaluation and approvals.
Key activities and roles essential for effective post-market control, will be introduced, including managing failures of conformance and compliance. Topics covered will include collaborations and networks for optimising post-market communications, and handling of substandard and falsified pharmaceuticals.
The module will interest students who are keen in global trending regulatory approaches and strengthening the skillsets to accommodate new innovation.
This module aims to equip students with skills to assess the therapeutic equivalence of a generic medicinal product relative to a comparator, specifically with respect to bioavailability (BA) and bioequivalence (BE).