17 June 2024

Pharmacoepidemiology and postauthorisation safety studies

Learn the principles of pharmacoepidemiology, data sources, post-approval safety studies (PASS) and related international legislation and guidelines.

Pharmacoepidemiology og postauthorisation safety studies

During this course, you will get a thorough insight into the principles of pharmacoepidemiology, data sources and the regulations, practice and processes related to post-approval safety studies (PASS)  This deals with both the regulatory authorities, the pharmaceutical industry and other partners involved in PASS.

The aim of the course is to give you knowledge about the principles of pharmacoepidemiology and the scientific and regulatory aspects of post-approval safety studies, PASS.

This course guides you through the different types of evidence produced by pharmacoepidemiological studies of adverse drug effects. We will go through the strengths and weaknesses of different study designs and methods.

You will learn to choose design and data sources that best fit the purpose of study, and to critically evaluate published literature on drug safety. 

Lectures are supplemented with group discussions based on real and simulated safety scenarios and scientific literature.

Prior to the course commencement, you may take part of some voluntary online theory exercises.


The topics of the course are many, and cover the entire area of pharmacoepidemiology:

Pharmacoepidemiological methods

  • Measures of occurrence and effect
  • Cohort and case-control study designs
  • Sources of error, bias and confounding
  • Basic statistical concepts in epidemiology
  • Analysis of epidemiological studies
  • Drug utilisation studies and quality indicators of drug use
  • Interpretation of study results, strengths and limitations

Data sources for post-approval studies

  • Primary and secondary data collection (healthcare databases)
  • Completeness, quality and validity of data
  • Choice of data for randomized clinical trials, low- and non-interventional studies
  • Data protection regulation, ethics and confidentiality

Post-approval safety studies (PASS)

  • The role of pharmacoepidemiological studies in pharmacovigilance and risk management
  • Regulatory processes and decisions involving PASS including the role of regulatory bodies (EMA, PRAC and CHMP, FDA)
  • Legislation, guidelines and methodological standards of PASS
  • Planning and conducting a PASS
  • The study protocol and the study report


After completion of the course, you will be able to:

  • Describe, analyse and interpret the results of pharmacoepidemiological studies
  • Describe and assess the limitations of data and methods in published literature and safety reports
  • Summarise and prioritise safety information obtained with different methods in a structured way
  • Independently develop a protocol and plan for a post-authorisation safety study applying the gained knowledge
  • Review, interpret and assess safety data obtained in pharmacoepidemiological studies
  • Assess benefit/risk, integrating results from post-approval safety studies (PASS) and other safety information



























Participants must meet the following criteria

  • Hold a relevant bachelor degree or equivalent
  • Have a minimum 2 years of relevant job experience
  • Be proficient in English

Find detailed information about the admission criteria.


























Course responsible
Morten Andersen, Professor, Department of Drug Design and Pharmacology, University of Copenhagen.

Morten Andersen, Professor, Department of Drug Design and Pharmacology, University of Copenhagen.
Maurizio Sessa, Assistant professor, Department of Drug Design and Pharmacology, University of Copenhagen.

Other guest lecturers
Professionals from safety / epidemiology / pharmacovigilance departments in the pharmaceutical industry and
regulatory agencies.

























This course is offered as an elective course in Master of Industrial Drug Development and Master of Medicines Regulatory Affairs.

Priority is given to students enrolled on Master of Industrial Drug Development or Master of Medicines Regulatory Affairs.

Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.













Course details

Duration: 5 days
Dates: 17-21 June 2024
Place: Atrium, Copenhagen, Denmark
Course fee:
Early Bird: Register by 27 March 2024, and save 3,000 DKK on the original prices stated below.
EU/EEA citizens: 30,000 DKK
Non-EU/EEA citizens: 33,555 DKK
The fee includes lunch/coffee.
Level and credit: Master course; 5 ECTS
Examination date: Please consult the exam schedule
Application deadline: 6 May 2024
Admission: To be admitted, you must meet the admission criteria for Master of Industrial Drug Development

Course dates and application deadlines are announced via the programme newsletter.
Download course curriculum