Banner Image for GMS5108 Clinical Studies and Evaluation of Health Products

GMS5108 Clinical Studies and Evaluation of Health Products


4 Units
 

The effective regulation of pharmaceuticals and medical devices for safety and efficacy depends on the availability, understanding and appropriate implementation of relevant guidelines and the processes designed to ensure quality in decision-making. The requirements are frequently different from traditional clinical trials and specific to regulatory affairs.

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

Learning Outcomes

  • Explain an overview of the design and phases of human clinical trials, as well as the regulatory requirements to support market approvals of pharmaceuticals, medical devices and technologies. 
  • Understand the standards and processes for submitting an application and evaluating the benefit-risk profile of a health product using a structured framework. 
  • Appreciate the contribution of these regulatory controls on the product life cycle and the role in ensuring quality, safety and efficacy of the products.