6-month Program: Pharmacovigilance & Patient Safety

Month 1 - Foundations of Pharmacovigilance | Focus: PV systems, history, definitions, global framework

Month 2 - ICSR Management & Safety Reporting | Focus: Case processing, seriousness, expectedness, timelines

Month 3 - Signal Detection & Safety Assessment | Focus: Signal methods, causality, safety evaluation

Month 4 - Risk Management Plans & Risk Minimization | Focus: RMPs, aRMMs, effectiveness evaluation

Month 5 - Patient Safety, Medication Errors & Quality Systems | Focus: patient safety, root cause analysis, CAPA

Month 6 - Regulatory Strategy, Benefit–Risk & Capstone | Focus: Health Canada/FDA/EMA, final applied project