Pharmacovigilance and Pharmacoepidemiology

Recommended Prerequisites

All courses taught in the Pharmaceutical Sciences master course are important for the understanding of matter taught in class. Students must have English language skills

Teaching Methods

Theoretical lectures with the participation of students in the analysis and comments to the topics that are being taught. Problems' solving.

Learning Outcomes

Provide students the skills to interpret pharmacoepidemiological studies with different designs in order to determine which therapeutic option has the best benefit/risk ratio. 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 and Pharmacoepidemiology regulatory, the responsibilities the stakeholders in the drug safety monitoring and to understand the National Pharmacovigilance System.

Work Placement(s)

No

Syllabus

Measures occurrence (frequency) of disease; Accuracy measures; Measures of association; Survival analysis; Study designs in Pharmacoepidemiology; Bradford-Hill criteria for causality assessment. 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

Head Lecturer(s)

Carlos Miguel Costa Alves

Assessment Methods

Final assessment
Exam: 100.0%

Bibliography

Pharmacoepidemiology, Sixth Edition (B. Strom, S.E. Kimmel, S. Hennessy, Wiley, 2019)

Bate A. (2018). Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects. Humana Press: New York.

Mann's Pharmacovigilance, Third Edition (EB Andrews, N Moore, Editors, Wiley-Blackwell, 2014)

European Medicines Agency. Good pharmacovigilance practices. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices