Pharmacovigilance and Pharmacoepidemiology

Recommended Prerequisites

Not applicable.

Teaching Methods

Theoretical lectures.

Learning Outcomes

Give students the skills to understand the drug safety evaluation throughout its entire life cycle. Provide students the skills to interpret pharmacoepidemiological studies with different designs in order to determine which therapeutic option has the best benefit/risk ratio. In addition, this course aims to instruct students about Pharmacovigilance and Pharmacoepidemiology 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. Measures occurrence (frequency) of disease; Accuracy measures; Measures of association; Survival analysis; Study designs in Pharmacoepidemiology; Bradford-Hill criteria for causality assessment.

Head Lecturer(s)

Francisco Jorge Batel Marques

Assessment Methods

Assessment
Exam: 100.0%

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.