Lecture

Regulation of Therapeutic Products

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In course

BIO-455: Introduction to law and ethics

The aim of this course is to introduce students to the basic legal and ethical concepts relevant to research in the life sciences and its translational application, and to provide them with the essential tools to identify legal and ethical issues in their ...

Description

This lecture covers the regulation of therapeutic products, including pharmaceuticals, cosmetics, and food items, emphasizing the importance of product classification. It discusses the legal requirements for manufacturing, storage, distribution, labeling, marketing, and market access. The course objectives include defining therapeutic products, understanding the regulatory framework, exploring the lifecycle of a drug, identifying authorization steps, and presenting advertising rules for medications. It also delves into Swiss Federal Constitution provisions related to health protection, formal laws safeguarding health, and the roles of various authorities in enforcing regulations. The lecture concludes with insights into the authorization process, distribution, prescription guidelines, pharmacovigilance, and enforcement measures.

Official source

Ontological neighbourhood

Statistics

Statistical inference: Mathematical statistics

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