Pharmacoepidemiology and Drug Safety

Course code
Course fee (excl. housing)
Course Level
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.

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.

Day-to-day programme (PDF)
Course director
Prof. dr. O.H. Klungel


Prof. dr. S. Suissa, Prof. Dr. A de Boer, Prof. Dr. A.C.G. Egberts, Prof. Dr. O.H. Klungel, Prof. Dr. T.P. van Staa, Dr. H. Gardarsdottir, Dr. D. Weir and others.

Target audience

(Post)graduates and professionals within governments, NGOs, industry, universities with a basic knowledge of public health/medicine, who have an interest in the policy aspects of pharmaceuticals and/or pharmacoepidemiology.

Aim of the course

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 fee:
Fee covers
Course + course materials + lunch
Housing fee:
Housing cost
Housing provider:
Utrecht Summer School
Extra information about the fee

The course can be combined with the course M07 Pharmaceutical policy analysis running from 11-15 July 2022. The combination fee is €1550,- when you participate in both courses. 

More information

Prof. dr. Olaf Klungel | E: | T: +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 .


Application deadline: 
Registration deadline
01 June 2022