The Medical Product Lifecycle: Pre- and Post-Market Regulation — Course | CARSP
Follow a medicine, vaccine or device from clinical trial to market to withdrawal, and see every regulatory function at work along the way.
Regulation is often taught function by function. Products, however, live a lifecycle — and a regulator's decisions at each stage depend on what came before and shape what comes after. This course follows that lifecycle.You will cover clinical trial authorisation and good clinical practice, the structure and assessment of a marketing-authorisation dossier, GMP inspection and licensing of establishments, risk-based classification and conformity assessment of medical devices, and the post-market world of pharmacovigilance, market surveillance, variations, recalls and withdrawal. Reliance pathways and the practical realities of African regulatory practice run throughout.Format: five modules, ten lessons with knowledge checks, one final assessment. Completion earns 5 CPD credits and a CARSP certificate. Learning outcomes: Describe the regulatory requirements at each stage of a medical product's lifecycle; Explain how a marketing-authorisation dossier is structured and assessed; Distinguish the regulatory approach to medicines from that for medical devices and diagnostics; Explain how pharmacovigilance and market surveillance detect and act on post-market problems; Apply reliance and risk-based approaches to lifecycle decisions
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