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

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.

Course topics

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.

For more details about the course, please refer to the course curriculum.

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Master of Industrial Drug Development