Learning outcomes

This course covers the different regulatory statuses that current therapeutic approaches may have. It also addresses the role of pharmacovigilance.


The courses are structured to encourage interaction with students. They aim to familiarize students with the regulatory environment for drugs and health products.

 

Goals

Understand how the different statuses (medical devices, drugs, advanced therapies, in vitro diagnostic devices) fit together.

Understand the main characteristics and advantages/disadvantages of each status.

Raise students' awareness of the importance of vigilance in terms of public health, using drugs as an example.

Content

The course consists of four sessions. The first session focuses on the various regulatory aspects of medicines. The second session focuses on medical devices and in vitro diagnostics. The third session addresses the specific status of biological medicines, with a particular focus on advanced therapies. Finally, the fourth session addresses the various aspects of pharmacovigilance.

 

Exercices

No exercises

 

Teaching methods

Lessons ex cathedra

 

Assessment method

The written exam in the form of open-ended questions takes place at the end of the year.


The exact modalities of the evaluation are likely to be modified during the preparation of the examination schedules, depending on the practical constraints with which the faculty administration may be confronted, or in the event of illness / force majeure / encroachment with an internship.

Sources, references and any support material

PowerPoint

 

Language of instruction

English