Pharmacoepidemiology and Drug Safety

About

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.

Course leader

Prof. dr. O.H. Klungel & Dr. D.L. Weir

Fee info