Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory
Liaison to External Organizations/Drug Safety Intelligence
PV Worker Education, Skills, and Profile
Chapter 32How an Individual Case Safety Report (ICSR) is Handled from Start to Finish
AE Sources and Arrival in the Safety Department
Case Distribution and Transmission
15 Calendar Days and Day 0 versus Day 1
Organizational Structure and Site Information
Computer, Forms, Electronic, and Print Resources
Corporate and Drug Safety SOPs, Working Documents, Guidelines, and Manuals
Medical Dictionary for Regulatory Activities (MedDRA®) and Other Dictionaries
Signaling and Pharmacovigilance
Chapter 35Audits and Inspections
The Response to the Inspection or Audit
The Corrective Action Preventive Action Plan (CAPA)
Comments on EMA and MHRA Inspections
Quality Systems and Inspection Preparation in Companies
Chapter 36Pharmacovigilance System Master File
Pharmacovigilance System Master File (Guideline on Good
Pharmacovigilance Practice Module II)
Chapter 37Ethical Issues and Conflicts of Interest