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 succesfully 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
  • Self-tests

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 final draft report
Sunday – complete Learning Units 7, 8 and 9

Week 4
Friday – submit final assignment


To successfully complete this pharmacoepidemiologic and drug safety course, you need to participate actively in the discussion forums and complete the final assignment. The deadline for the final assignment will be announced as soon as possible. You will be able to redo the final assignment once. 


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 enrol in this course, you need:

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 face to face. For more information about this option, please visit the website of the Utrecht Summer School

Course staff

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Pick a date for this course:
(Enrollment deadline: 26 August 2019 - 23:59 CET)
72 days left.

Quick overview

  • 2 Sep 2019 – 22 Sep 2019
  • 3 weeks
  • 13 hrs/wk
  • Academic Certificate
  • 1.5 EC
  • Online
  • English
  • Weblectures, exercises, group discussions
  • Desktop, Laptop, Smartphone, Tablet
  • 785

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