THE PHARMACOVIGILANCE INTERVIEW

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ISRHEWs
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2012 EMEA Changes
Spontaneous reports
MedDRA
WHO Drug Dictionary
Causality Assessment
Regulatory Submission – LAREB,FDA,MHLW,BfarM
Unblinding & SUSAR
PBRER
Workflow, Post Treatment and Pre-Treatment Study
The Pharmacovigilance System – Eudravigilance.
EMEA- GVP
FDA: Adjudication and Advisory Panel
Back To The Future: Vioxx, Mediator & Thalidomide
Regulation and Directive on Pharmacovigilance
The Pharmacovigilance Interview
Serious vs Non-Serious: Case study & Thumb Rules

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