Pharmacovigilance/ Drug Safety theory :-
• History and overview of Pharmacovigilance
• Regulatory Authorities country wise
• Pharmacovigilance in India
• Spontaneous reporting
• Active pharmacovigilance
• Cohort Event Monitoring
• Adverse Events and its types
• Drug Safety in clinical trials and post marketed drugs
• Different sources of Adverse Events reporting
• Different types of AE Reporting Forms
• Expedited reporting and its timelines
• Aggregate reporting
• Different departments working on Pharmacovigilance
• Business workflow of Pharmacovigilance
• Minimum criteria for the case
• Causality assessment of the adverse event
• Expectedness assessment of the adverse event
• Seriousness assessment of the adverse event
• MedDRA and WHODD coding
• SAE narrative writing and Templates
• PBRER/PSUR and its submission timelines
• E2A-E2F Guidelines
• PADAR
• Explanation of Safety Signals, Signal Detection at UMC
• Signal publication and communicating signal
• Risk management