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Pharmacovigilance and Pharmacoepidemiology. MedDRA Coding, ICSR, Types of reports, Causality, SUSAR, EMEA, GVP, Eudravigilance, FDA, MedWATCH, Signal Detection, List of IME, and Narrative Writing. NIS (Non interventional study), PASS (Post authorisation safety study). Role of epidemiology in RMP (Risk Management Plan), CER (Competitive Efectiveness research), Post Marketing risk profile and Post marketing Signals. Cohort, Case control and study designs. EuPAS, Good Pharmacoepidemiology Practice (GPP), STROBE, EnCePP, Protocol and Guidelines.
