Pharmacoepidemiology, Post-authorisation Safety Studies, and Real-World Data

Summary

Developed with the University of Copenhagen, this course covers the principles of pharmacoepidemiology, data sources, post-approval safety studies (PASS) and related international legislation and guidelines. The regulations, practices and processes related to PASS are also included, covering both the pharmaceutical industry and the role of the regulatory authorities (EMA, PRAC and CHMP, FDA).

At this five day course, you will acquire an understanding of the different types of evidence produced by pharmacoepidemiological studies of adverse drug effects, and of the strengths and weaknesses of different study designs and methods. Additionally, you get a basic understanding of how to apply these skills in pharmacovigilance and risk management.

After completing the course, you will be able to choose the design and data sources that best fit the purpose of a given study and to critically evaluate published literature on drug safety. You will also know how to integrate results from drug safety surveillance.

At the course, lectures are supplemented with group discussions based on real and simulated safety scenarios and scientific literature. Prior to the course there will be some online theory exercises.

This course is an elective course for students at University of Copenhagen's Master of Industrial Drug Development (MIND). The course is open to single course students and students from other master's programmes. 
 

Keywords

• Pharmacoepidemiology
• Risk management
• Healthcare databases
• Evidence
• Post-authorisation safety studies (PASS)
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Please note:

As this course is offered in collaboration with the University of Copenhagen, you apply via the joint Atrium and University of Copenhagen application form. This means that you will be enrolled at both Atrium and the University of Copenhagen, and that your data will be registered at both institutions. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

Course fee includes examination. By default, you pay the full amount to the University of Copenhagen regardless of whether you take the exam or not. If you decide not to take the exam, you can apply for a refund of the exam fee by contacting Atrium – please see contact details below. You must apply for a refund no later than two weeks after completion of the course.