Pharmacovigilance (2022/2023)

Faculteit Science and Engineering
Jaar 2022/23
Vakcode WMMP011-05
Vaknaam Pharmacovigilance (2022/2023)
Niveau(s) master
Voertaal Engels
Periode semester II a (Biennial course, runs in 2022/2023)
ECTS 5
Rooster rooster.rug.nl

Uitgebreide vaknaam Pharmacovigilance (2022/2023)
Leerdoelen 1.The students can describe the way the pharmacovigilance is organized.
2.The student can argue in which context the national and European rules and regulations for drug safety are being applied.
3.The students can interpret the scientific methods that are being used for discovering and analysis of hitherto unknown adverse drug reactions in the pre- and post marketing phase.
4.The students can judge on the use of scientific arguments and ethical considerations on topics of risks and the safety of drugs and vaccines.
5.The students can apply pathophysiological principles in the assessment of adverse drug reactions (ADRs).
6.The students have knowledge of the clinical presentation and occurrence of ADRs.
7.The students can assess the causal relationship between drugs and potential ADRs.
8.The students can argue which patients are at risk for developing ADRs.
9.The students can decide which actions to take when ADRs occur, both on an individual an population level.
Omschrijving Drug safety takes place on the intersection of clinical practice, pharmaceutical sciences and drug regulation. In this course, clinical, scientific and organizational aspects of pharmacovigilance will be discussed. This course aims to provide a broad insight in various aspects of drug safety.
Attention is paid to the clinical presentation of frequently occurring or serious adverse drug reactions (ADRs) and ways to assess the causal relationship between the use of drugs and possible ADRs. In addition, ways in which new adverse drug reactions are detected once drugs are available on the market will be presented.
Uren per week
Onderwijsvorm Hoorcollege (LC), Opdracht (ASM), Practisch werk (PRC)
Toetsvorm Meerkeuze toets (MC), Opdracht (AST)
(The final mark of the course unit is determined by: • Multiple Choice Exam, accounting for 55% • Written assignment accounting for 45%. If more than 55 % of the possible points have been obtained the student passes the exam.)
Vaksoort master
Coördinator prof. dr. E.P. van Puijenbroek
Docent(en) R. van Eekeren-Buiten ,prof. dr. E.P. van Puijenbroek
Verplichte literatuur
Titel Auteur ISBN Prijs
Hand outs of the lectures
Articles will be made available on NESTOR
List of relevant websites (EMA,FDA,Lareb, CBG/MEB) is provided
Entreevoorwaarden The course unit assumes prior knowledge acquired in the bachelor phase Medical and Pharmaceutical Sciences.
Opmerkingen Approx. 6 to 10 4-year students from the master programme(s) are participating in the course unit. The course unit is an elective, for instance in the pharmacoepidemiology track

Biennial course, runs in 2022/2023
Opgenomen in
Opleiding Jaar Periode Type
MSc Medical Pharmaceutical Sciences: Drug Toxicology & Translational Technology  ( Track choice) - semester II a keuze
MSc Medical Pharmaceutical Sciences: Pharmaceutical Design and Engineering  (Other possible Electives) - semester II a keuze
MSc Medical Pharmaceutical Sciences: Pharmacoepidemiology & Pharmacoeconomics  ( Track choice) - semester II a keuze
MSc Medical Pharmaceutical Sciences: Research  (Electives) - semester II a keuze
MSc Medical Pharmaceutical Sciences: Science, Business and Policy  (Electives ) - semester II a keuze