Lecture

Regulation of Therapeutic Products

Description

This lecture covers the regulation of therapeutic products, including the classification, manufacturing requirements, market placement conditions, and enforcement authorities. It delves into the distinction between therapeutic products, foodstuffs, and cosmetics, emphasizing the importance of proper authorization for medicines. The instructor explains the legal framework governing health protection in Switzerland, detailing laws on medicines, food, narcotics, and dangerous substances. The lecture also explores the authorization process for therapeutic products, from manufacturing to distribution, highlighting the significance of Swissmedic approvals. Additionally, it discusses the lifecycle of a human-use drug, from research to post-marketing surveillance, and the pharmacovigilance obligations. The session concludes with insights on advertising regulations, inspections, administrative measures, and sanctions in the pharmaceutical sector.

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