3. ISBN : 1500738115
Author : Dr Ravi Humbarwadi
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4. 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.
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