Pharmacovigilance
3
2023-2024
01550981
HEALTH SCIENCES AND TECHNOLOGIES
Portuguese
Face-to-face
SEMESTRIAL
4.0
Compulsory
1st Cycle Studies
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. Língua
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)
NoSyllabus
The National Pharmacovigilance System, causality assessment, safety signals generation and confirmation, spontaneous reporting procedures, risk ratio estimate based on spontaneous reporting data, risk minimization measures, drugs under additional monitoring, pharmacovigilance in clinical trials.
Head Lecturer(s)
Francisco Jorge Batel Marques
Assessment Methods
Assessment
Synthesis work: 25.0%
Exam: 75.0%
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