Modules

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 foundation in understanding the regulatory science behind the development, manufacturing and control of pharmaceuticals, including the global guidances that shape the regulatory processes.

This module provides the understanding for the unique requirements of clinical trials and clinical data meant to support regulatory evaluation and approvals.

The module will interest students who are keen in global trending regulatory approaches and strengthening the skillsets to accommodate new innovation.

This module provides the background to the rise of these biologicals in healthcare, and the defining differences from traditional pharmaceuticals and generics.

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).

This module provides the foundation in understanding established standards, guidelines and regulatory principles on conformity assessment of medical device softwares.

This module provides the foundation in IVDs regulatory principles, use in precision medicine and companion diagnostics. It also provides an introduction to standards and guidelines playing a pivotal role in meeting requirements to ensure product safety, quality and performance.

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.

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.

This module introduces the key activities and roles essential for effective post-market vigilance, including adverse events, field safety correcting action and change management.