Clinical Studies and Evaluation of Health Products (classroom & Asynchronous E-Learning)

This course will provide 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. Participants will also learn about the standards and processes for submitting an application and evaluating the benefit-risk profile of a health product using a structured framework. Upon completion of this course, students would appreciate the contribution of these regulatory controls on the product life cycle and the role in ensuring quality, safety and efficacy of the products.

What You'll Learn

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.

Minimum Entry Requirement

• Bachelor's Degree.
• Relevant experience in the field of health products regulatory affairs