Pharmacovigilance: Principles & Practice

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ISRHEWs
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Spontaneous Reports
 Time Frames For Regulatory Reporting
MedDRA
WHO Drug Dictionary
 Action Taken, DC and RC
Causality Assessment
Unblinding @ SUSAR
Post Treatment and Pre-Treatment Study
Eudravigilance.
 EMEA – GVP VI
 FDA: Adjudication and Advisory Panel
 Vioxx, Mediator; Thalidomide
Signal Detection
 ARGUS
Narrative Writing – Rules & Format .
 Important Medical Event List
 Serious vs Non-Serious: Thumb Rules

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