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Pharmacovigilance
About This Course
Content
COMMUNITY
Schedule
Introduction
Overview
Good PV practice
Evolution of PV
Quiz 1
Pharmacosystem 1
Overview
Inspection
Risk management
Quiz 2
Pharmacosystem 2
Periodic safety update reports
Post-authorization safety studies
Clinical trials
Quiz 3
Reporting
Overview about reporting
Unsolicited reports
Follow up report
Quiz 4
Risk management
Overview
Risk management plan
risk minimisation measures
Quiz 5
Adverse events
Overview
AE severity
Patient case examples
Quiz 6
How to detect AE
Overview
Methods of AE detection
Involuntary manuals
Quiz 7
How to document AE
Overview
AE Reporting by the Registry
Grades of AE
Quiz 8
Local authorities
Overview
SFDA
Marketing Authorization Holders
Quiz 9
Global authorities
Overview
Post marketing safety monitoring
Risk and crisis management
Quiz 10
