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. 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 successfully participate in this course you will need a medical education or a degree in biomedical or life sciences.

Pharmacoepidemiology & Drug Safety is one of the online medical courses of the MSc Epidemiology Postgraduate Online; the online MSc program in Epidemiology offered by Utrecht University, University Medical Center Utrecht, MSc Epidemiology and Elevate Health.

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

Learning Methods

The whole course will take place online. The following learning methods will be used:

Web lectures
Group assignments

Course Deadlines

Please note that you are required to hand in assignments during some of the learning units in this course:

Week 0
Sunday before start date - introduce yourself

Week 1
Sunday – complete Learning Units 1, 2 and 3

Week 2
Monday – submit short report 3.4
Sunday – complete Learning Units 4, 5 and 6

Week 3
Friday – submit the final draft report
Sunday – complete Learning Units 7, 8 and 9

Week 4
Friday – submit the final assignment


As Pharmacoepidemiologic and Drug Safety is a university course, it is covered by academic accreditation. Upon successful completion of this course, you will receive a recognized certificate from Utrecht University and the UMC Utrecht.

Entry Requirements

To enroll 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

Please note
As this is an online course, you do need access to an internet connection in order to be able to follow lectures, complete assignments and communicate with fellow participants.

This course is also available offline.

The course is offered by


As part of the following program

Program taught in:
  • English (US)

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This course is Online
Start Date
3 weeks
785 EUR
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