Learning objectives
The course aims to enable the student to know and understand the basic elements related to the Pharmacovigilance system also in order to allow the student the ability to use the knowledge and understanding for the control and surveillance of marketed drugs. The course also aims to provide the knowledge and ability to understand concerning the nature and the mechanisms underlying the adverse effects of drugs.
Prerequisites
None
Course unit content
- The Basics of Pharmacovigilance
- The concept of risk
- Mechanisms of clinically relevant adverse reactions
- Spontaneous reports of ADRs
- Pharmacoepidemiology, general concepts
- The risk menagement
- Legislation in Pharmacovigilance
- The protagonists of Pharmacovigilance and the situation in Italy and Europe
Full programme
- The Basics of Pharmacovigilance
- The concept of risk
- Mechanisms of clinically relevant adverse reactions
- Spontaneous reports of ADRs
- Pharmacoepidemiology, general concepts
- The risk menagement
- Legislation in Pharmacovigilance
- The protagonists of Pharmacovigilance and the situation in Italy and Europe
Bibliography
1) Elementi di Farmacovigilanza
P. Rossi
(Ed. 2009) SEE-Firenze
2) Cobert's Manual of Drug Safety & Pharmacovigilance
(2nd edition, 2011) Jones and Bartlett Learning
Teaching methods
Oral lecture integrated with power point slides. The student at the end of the course, using the knowledge gained will need to demonstrate knowledge and understanding about the rules of Pharmacovigilance, as these are motivated, edited and shown to users.
Assessment methods and criteria
The assessment of the achievement of the objectives of the course consists of a written exam followed by oral examination. Through questions about the contents of the course will be determined whether the student has achieved the goal of knowledge and understanding of the content.
Other information
None
