Learning Outcomes
To design a clinical pharmacoepidemiology study
Group working
Improve ADR reporting culture
Minimizing medication errors
Training of the Health Care professional to fill and submit successfully the national reporting form
Educating post-graduate students on PV and developing a positive ADR reporting culture
Training on causality assessment
WHO-UMC causality assessment scale
Course Content (Syllabus)
Introduction into Pharmacoepidemiology
Inspiration by harm in individual patient
Occurrence relation
Causality, counfounding, channeling
Pharmacoepidemiological study design
Group work: design your study
Introduction into Pharmacovigilance
Developing a positive ADR reporting culture
PV methods
Mechanisms of ADR and risk factors
Signal detection
Using real world data to detect safety signals
Logic of causality and single case assessment
Statistical methods in signal detection
The yellow card scheme of EOF (theory and training)
Keywords
pharmacoepidemiology, pharmacovigilance, drug safety, patient safety, adverse drug reactions, clinical study design, yellow card scheme