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Pharmacoepidemiology and drug safety

Course Description: This course covers the fundamental concepts of pharmacoepidemiology and its applications in drug safety assessment and monitoring. The course includes the study of epidemiological research designs, data sources, measures of disease frequency and drug risk, as well as concepts of pharmacovigilance and adverse event reporting systems. Students will also be introduced to medication use review, risk analysis and management, and drug safety systems at national and international levels, with a focus on practical application in healthcare settings.
Credits: 1
Prerequisites: MATH135
Objectives of the course :

The course aims to introduce students to:

 

Core Concepts and Theory in Pharmacoepidemiology.
Roles and Responsibilities of Specialists in the Field
Prerequisites for conducting pharmacoepidemiological assessments and procedures.
Commonly used study designs.
Strengths and weaknesses of those designs
Rules and equations used in epidemiological calculations.
Practical application on typical scenarios and cases.

Course outputs :

Learning Outcomes (CLOs):
Explain the role of outcome research in pharmacoeconomics.
1.2 Description of different types of outcomes research.
1.3 Description of methods and steps required to conduct pharmacoepidemiological assessments.
1.4 Describe the concept of pharmacoepidemiology and its application in pharmaceutical practice.
1.5 Describe the concept of post-marketing surveillance and its limits and ethical considerations.
2.1 Application of Pharmacological Epidemiology Concepts to Clinical Practice.
2.2 Differentiating between different types of pharmacoepidemiological methods.
2.3 Application of Concepts in the Monitoring, Evaluation, and Approval of New Drugs.
2.4 Conduct pharmacoepidemiological research and analysis.
2.5 Reporting adverse drug reaction risks to regulatory authorities.

Additional information:
  • Last updated: 2026-05-12

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