Learning Outcomes
- Understand the concept of pharmacovigilance and its basic principles. Specifically, issues related to the safety of traditional chemical drugs, biological drugs, and vaccines.
- Understand the process of spontaneous reporting of adverse drug reactions.
- Successfully complete the Yellow Card reporting for drugs.
- Conduct the process of causality assessment of adverse drug reactions using the WHO methodology.
- Understand the benefit/risk ratio in the use of drugs and vaccines.
Course Content (Syllabus)
- Basic principles of pharmacovigilance
- Safety of chemical drugs
- Safety of biological drugs
- Safety of vaccines
- Safety of COVID-19 vaccines
- Placebo effect
- Disproportionality analysis
- The Yellow Card for drugs
- Process of assessing causality of adverse drug reactions