LFU:online

Students understand post-marketing surveillance including pharmacovigilance

•    Pharmacovigilance obligations post-marketing
•    PBRER structure and development
•    Post-Authorization studies: safety and efficacy studies,
•    Medical Safety assessment, literature search, relevant databases (FAERS, EV, WHO),
•    Case Management activities serious vs non-serious ICSR obligations,
•    Risk management plan (RMP): concept, development and maintenance
•    Risk Benefit Assessment in Pharmacovigilance and its impact on the active subsrance as well as class of compounds,
•    Signal Detection activities and methods/Safety Science activitites,
•    QPPV role and oversight, PMSF
•    Pharmacoepidemiology and its relevance for benefit-risk assessments

Lecture with interactive elements involving student participation, audience response systems, online handouts

written exam

Modules 1 and 2