Foundations of Medical Products Regulation — Course | CARSP
Why medical products are regulated, what a regulator does, and the principles that make regulation credible — the grounding every regulatory professional needs.
Every medicine, vaccine and medical device reaching a patient has passed through a regulatory system — or has evaded one. This course explains what that system is for, how it is organised, and what separates a credible regulator from a nominal one.You will work through the public-health rationale for regulation, the core regulatory functions recognised by the WHO Global Benchmarking Tool, the actors and their responsibilities, and the good regulatory practices — legality, independence, proportionality, transparency — that underpin trust. The African regulatory landscape is used throughout as the reference context.Format: five modules, ten lessons with knowledge checks, one final assessment. Completion earns 4 CPD credits and a CARSP certificate. Learning outcomes: Explain the public-health and economic rationale for regulating medical products; Describe the core regulatory functions and how they fit together as a system; Identify the actors in a regulatory system and their responsibilities; Apply the principles of good regulatory practice to everyday regulatory decisions; Situate national regulatory systems within the African and global context
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