Pharmacoepidemiology and postauthorisation safety studies

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.

Lecturers
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.