Pharmacovigilance

Recommended Prerequisites

All courses taught in the 1st, 2nd and 3rd years of the LFB are important for the understanding of matter taught in class. Students must have English language skills.

Teaching Methods

Theoretical and theoretical-practical lectures with the participation of students in the analysis and comments to the topics that are being taught.

Learning Outcomes

Give students the skills to understand the drug safety evaluation throughout its entire life cycle. In addition, this course aims to instruct students about Pharmacovigilance regulatory, the responsibilities the stakeholders in the drug safety monitoring and to understand the National Pharmacovigilance System.

Work Placement(s)

No

Syllabus

The National Pharmacovigilance System, causality assessment, safety signals generation and confirmation, spontaneous reporting procedures, risk ratio estimate based on spontaneous reporting data, the clinical course of adverse drug reactions, Pharmacovigilance in clinical trials, Dictionary MedDRA: terminology.

Head Lecturer(s)

Francisco Jorge Batel Marques

Assessment Methods

Assessment
Other: 20.0%
Exam: 80.0%

Bibliography

ANDREWS, Elizabeth, MOORE, Nicholas - Pharmacovigilance. 3rd ed. Wiley-Blackwell, 2013
Textbook of pharmacoepidemiology

John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex PO19 8SQ, England.