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Pharmacovigilance Principles & Practice

Author Name: Pro-career | Format: Paperback | Genre : Educational & Professional | Other Details

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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Pro-career

Pro-career.net is an online site specializing in content, courses and training for professionals. Career oriented online library in all drug safety topics such as MedDra, pharmacovigilance, signal detection, narrative writing, pharmacovigilance database and analytics.

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