Drug and Society
- UE code MSBMM115
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Schedule
12Quarter 2
- ECTS Credits 2
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Language
English
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.
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.
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.
No exercises
Lessons ex cathedra
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.
PowerPoint
Training | Study programme | Block | Credits | Mandatory |
---|---|---|---|---|
Master in Biomedical Sciences, Professional focus in Preclinical Research | Standard | 0 | 2 | |
Master in Biomedical Sciences, Professional focus in Preclinical Research | Standard | 1 | 2 |