Fundamentals of Health Products Regulation (Competence)

'Regulation of health products is controlled by standards, guidelines and legal frameworks. The interactions among these and the stakeholders � industry, regulatory authorities, healthcare professionals and patients � are required for effective governance for timely access and safe, quality and efficacious medicines and medical devices for patients. This 4-unit course provides the understanding of the contribution of the various stakeholders, functions and guidelines that shape the regulatory environment and impact the healthcare management scene. The concept of product life cycle will be also be explored among other contemporary regulatory approaches.'