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Pharmacoepidemiology and Drug Safety

Organizing institution
Utrecht University - Faculty of Science
Course code
Course fee (excl. housing)
€ 975.00
Advanced Master
The course will provide insight in study design and analysis in pharmacoepidemiologic and drug safety research. Methodological issues are presented in the context of decision making on medicines. The course takes a multi-stakeholder perspective and applies educational approaches to facilitate interaction between these stakeholders among the participants. It is an intensive programme which covers many relevant topics concerning pharmacoepidemiology.

With the prospect that innovative drug therapies will be introduced in the coming years, society demands new approaches and concepts for comparative risk/benefit evaluation. Assessment of safety and risk management of different drug therapies is done in the framework of observational epidemiological studies (proof of ‘safety’, proof of ‘effectiveness’). This is the logical next step after randomized clinical trials, which are designed to provide evidence of a drugs ‘efficacy’.

The course will cover key issues in pharmacoepidemiologic and drug safety research. Students will learn about the typical problems (e.g. confounding by indication, rare side effects) and approaches to deal with these problems in the practice of pharmacoepidemiology. Special topics include databases, advanced exposure ascertainment, propensity scores, and instrumental variables. 

You will experience an intensive programme covering the following topics: Study Design and Methods; Confounding and other biases; Methods in drug safety research; Drug Safety and Risk Management; Overview of Pharmacoepidemiological databases; Drug utilization research; Synthesis, case studies & public health.

Download the day-to-day programme (PDF) Apply online now!

Course director

Prof. dr. O.H. Klungel


Prof. S. Suissa, Prof. H.G.M. Leufkens, Prof. A. de Boer, Prof. A.C.G., Egberts, Prof. O.H. Klungel, Prof. T.P. van Staa, Dr. H. Gardarsdottir, Dr. F. de Vries

Course aim

Students will learn about the typical problems and approaches to deal with these problems in the practice of pharmacoepidemiology.

Study load

1 week fulltime


Course + course materials + lunch € 975.00
Housing € 200.00 , through Utrecht Summer School

The course can be combined with the courses M7 - Pharmaceutical Policy Analysis, M14 - Pharmacoeconomics and/or M34 Future Medicines: Gene & Cell Therapies to receive a discount. When combined with one of the other courses, the discount will be € 200.00 per course. When combined with two of the other courses, the discount will be € 300.00 per course.

More information

Prof. dr. Olaf Klungel
E: O.H.Klungel@uu.nl
P: +31 6 288 31 313

For summer school participants interested in the topic of Pharmacoepidemiology and Drug Safety this Elevate course by Prof. dr. Olaf Klungel could be interesting as well: Go to Elevate website .
Recommended combinations
Pharmaceutical Policy Analysis


Application deadline: 25 June 2018