Pharmacoepidemiology and Drug Safety

Pharmacoepidemiology and drug safety: a current issue. With the prospect that even more innovative drug therapies will be introduced in the coming years, society is demanding new approaches to comparative risk/benefit evaluation, as well as new concepts. Such evaluations are usually carried out only once the relevant therapies have been used widely in daily practice.

Prof. dr. O.H. (Olaf) Klungel
Professor of Pharmacoepidemiology Methods
  • 3 weeks - 14 hrs / wk
  • Academic Certificate
  • 1.5 EC
  • Online
  • English
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Inschrijving sluit op 26/08/2024 44 dagen tot einde inschrijving
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Course description

The safety and risk management assessment of different drug therapies is then performed within the framework of observational epidemiological studies (e.g. to establish proof of ‘safety’ and proof of ‘effectiveness’). This is the logical next step after randomized clinical trials, which are designed to provide evidence of a drug’s ‘efficacy’.

During this Pharmacoepidemiology and Drug Safety course, you will learn about typical problems, (such as confounding by indication, or rare side effects) and various pharmacoepidemiologic approaches to dealing with these problems.

The course will cover key issues in pharmacoepidemiologic and drug safety research. Special topics you will discuss include adjustment for confounding, risk detection and management, molecular pharmacoepidemiology and public health. To succesfully participate in this course you will need a medical education, or a degree in biomedical or life sciences.

Learning objectives

By the end of this pharmacoepidemiologic and drug safety course, you will be able to:

• Broaden your understanding of pharmacological study design issues and methods
• Explain confounding and other biases, including the indication-related methods of adjusting for confounding
• Distinguish between different methods of drug safety research
• Describe the principles of drug safety and risk management
• Have an overview of the role of pharmacoepidemiological databases
• Understand the essence of molecular pharmacoepidemiology
• Have insight into drug utilization research

Course topics

• Cohort and case-control study designs
• Confounding and other biases – introduction/new approaches
• Critical appraisal of publications
• Overview and application of pharmacoepidemiologic databases
• The future of electronic health record database research
• The value of individual patient observations in drug safety research
• Continuous evaluation of harm/benefit
• Molecular pharmacoepidemiology


To successfully complete this pharmacoepidemiology and drug safety course, you need to participate actively in the discussion forums and complete the final assignment. You will be able to redo the final assignment once.


To enrol in this course, you need:

• A BSc or Master’s degree in (Bio)medical or Life Sciences
• Preferably to already have taken the course Introduction to Epidemiology
• Preferably to already have taken the course Study Design in Etiologic Research
• Preferably to already have taken the course Clinical Epidemiology
• Sufficient proficiency in English reading and writing

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