SMIM25001U Pharmacoepidemiology, post-authorisation safety studies and real-world data

Volume 2026/2027
Education

Master of Industrial Drug Development (MIND) - elective

The course is preapproved as an elective in the   Master Medicines Regulatory Affairs (MRA) programme. It is also open to single course students who meet the admission criteria.

Content

The course covers the principles of pharmacoepidemiology, data sources, post-approval safety studies (PASS) and related international legislation and guidelines. The regulations, practice and processes related to PASS are also included. This deals with both the regulatory authorities, the pharmaceutical industry and other partners involved in PASS. Lectures are supplemented with group discussions based on real and simulated safety scenarios and scientific literature. Topics are:

  • 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 (real-world 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
  • 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
Learning Outcome

The aim of the course is to give students knowledge about the principles of pharmacoepidemiology, the scientific and regulatory aspects of PASS, and the use of real-world data. Additionally, to provide students with 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. The students should be able to choose design and data sources that best fit the purpose of study, and to critically evaluate published literature on drug safety. They should further be able to integrate results from safety surveillance and post-approval studies with other preclinical and clinical safety information.

After completing the course the student is expected to be able to:


Knowledge

  • explain and discuss pharmacoepidemiological methods used to generate evidence on drug safety
  • explain central pharmacoepidemiological concepts.
  • explain and discuss the role of PASS in pharmacovigilance and risk management
  • explain and discuss relevant legislation and guidelines covering PASS
  • explain and discuss the obligations of the pharmaceutical industry and the basis for regulatory decisions related to PASS
  • identify and summarise the limitations of pharmacoepidemiological studies

 

Skills

  • 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


Competencies

  • Independently develop a protocol and plan for a post-authorisation safety study using real-world data, applying the gained knowledge
  • Review, interpret and assess safety data obtained in pharmacoepidemiological studies
  • Assess benefit/risk, integrating results from PASS and other safety information

The syllabus comprises selected chapters from Strom’s Pharmacoepidemiology, 6th edition, relevant legislation (including EU directives, EMA guidelines), good pharmacoepidemiology practice guidelines, other book chapters, scientific papers and review papers.

During the course further material consisting of lecture handouts, notes, articles, and case studies will be distributed.

A list of reading material will be distributed electronically before the course with recommendations for reading before the course and as preparation for the examination.

Applicants must meet the following criteria:
• A bachelor's degree, a professional bachelor’s degree, a diploma degree, a master’s degree or equivalent within chemistry, biochemistry, pharmacy, medicine, biomedicine, human biology, molecular biology, veterinary sciences, health sciences, nursing, engineering or equivalent.
• At least two years of relevant work experience related to development of medicines
• Proficiency in English
Lectures, practical exercises and group work. Pre-course web theory exercises.
  • Category
  • Hours
  • Lectures
  • 20
  • Preparation
  • 100
  • Theory exercises
  • 15
  • Exam
  • 3
  • Total
  • 138
Oral
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
Credit
5 ECTS
Type of assessment
Home assignment, 3 hours
Type of assessment details
Define an action plan on the basis of a case study (40%). The case study concerns a drug safety problem presented with a short description, data from case reports, a study report and/or a scientific publication. The student is expected to write a brief assessment of the safety problem and present an action plan including a protocol synopsis for a post-authorisation study.
Short descriptive questions (60%)
The set exam assessment is based on the combined evaluations of case study and questions.

The examination will be held on Digital Exam - The online platform for examination at the University of Copenhagen - approximately two weeks after completion of the course.
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
No external censorship
Exam period

See exam schedule. 

Re-exam

Same as ordinary.

Criteria for exam assesment

To achieve a grade of 12, the student must be able to:

Knowledge

  • explain and discuss pharmacoepidemiological methods used to generate evidence on drug safety
  • explain central pharmacoepidemiological concepts.
  • explain and discuss the role of PASS in pharmacovigilance and risk management
  • explain and discuss relevant legislation and guidelines covering PASS
  • explain and discuss the obligations of the pharmaceutical industry and the basis for regulatory decisions related to PASS
  • identify and summarise the limitations of pharmacoepidemiological studies

 

Skills

  • 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


Competencies

  • 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 PASS and other safety information