Pharmaceutical legislation and ethics [MPHAM210]

Learning outcomes

Understand and assimilate the main texts concerning the different pharmaceutical activities and the different stakeholders, as well as the administrative and economic steps involved in the drug from its development to its marketing, post-marketing follow-up and delivery to the patient.

Objectives

The objectives of this course are to raise awareness of the responsibility (legal, professional, social and moral) of those who exercise a profession in the field of medicine. The exercise of this responsibility is linked to the practice of pharmaceutical laws and regulations. The obligations of the various parties involved: pharmacists, those responsible for placing a medicine on the market, manufacturers, wholesalers and authorities are reviewed. Emphasis is placed on the purpose of this legislation.

Content

Introduction to pharmaceutical law, definition of a medicine, obligations of the dispensing pharmacist, legislation on the manufacture, distribution, wholesale and marketing of medicines, pharmacovigilance, advertising and information, role of the authorities. Pharmacovigilance will be discussed from different angles (causality principle, spontaneous notification system) and different international databases will be presented as well as the regulatory tools for monitoring post-marketing safety. A part of the course will deal with the development of the drug from its development to its marketing through the different stages of registration and the marketing of the finished product. Finally, the concept of Quality will be presented to you as well as the different tools to be used in the context of FAMHP inspections.