Pharmacovigilance

Key Concepts Covered:

• What is Pharmacovigilance?
• Importance of Drug Safety
• Objectives of Pharmacovigilance
• Pre-Marketing vs Post-Marketing Safety
• Pharmacovigilance Lifecycle

Key Concepts Covered:

• Adverse Event (AE)
• Adverse Drug Reaction (ADR)
• Suspected Adverse Reactions
• Medication Errors & Special Situations
• AE vs ADR

Key Concepts Covered:

• Spontaneous Reports
• Clinical Trial Safety Data
• Literature Sources
• Consumer & Healthcare Professional Reports
• Post-Marketing Safety Sources

Key Concepts Covered:

• What is an ICSR?
• Four Minimum Criteria for a Valid Case
• Case Identification
• Case Intake
• Initial Case Assessment

Key Concepts Covered:

• Case Receipt & Data Entry
• Duplicate Case Identification
• Data Review
• Case Follow-Up
• Case Closure Concepts

Key Concepts Covered:

• Serious vs Non-Serious Cases
• Seriousness Criteria
• Severity Assessment
• Expected vs Unexpected Events
• Assessment Examples

Key Concepts Covered:

• What is Causality?
• Drug-Event Relationship
• Temporal Relationship
• Alternative Causes
• Causality Assessment Approaches

Key Concepts Covered:

• What is MedDRA?
• MedDRA Hierarchy
• System Organ Class
• Preferred Terms & Lowest Level Terms
• Medical Coding Concepts

Key Concepts Covered:

• Purpose of Case Narratives
• Patient & Event Information
• Drug & Medical History
• Clinical Course & Outcome
• Writing a Clear Safety Narrative

Key Concepts Covered:

• Pregnancy & Lactation Cases
• Medication Errors
• Overdose & Misuse
• Lack of Efficacy & Other Special Situations
• Follow-Up Information

Key Concepts Covered:

• Safety Database Fundamentals
• Case Entry & Data Fields
• Workflow & Case Status
• Quality Review
• Safety Database Concepts

Key Concepts Covered:

• What is a Safety Signal?
• Signal Detection Fundamentals
• Signal Validation
• Signal Assessment
• Signal Management Concepts

Key Concepts Covered:

• Aggregate Safety Reports
• Periodic Safety Reporting Concepts
• Benefit-Risk Assessment
• Safety Data Analysis
• Aggregate Report Structure
• Keep this at conceptual level in a 16-hour course rather than attempting detailed regulatory report preparation.

Key Concepts Covered:

• Pharmacovigilance Regulatory Framework
• Regulatory Authorities
• Expedited Reporting Concepts
• Reporting Timelines
• Good Pharmacovigilance Practices

Key Concepts Covered:

• End-to-End PV Workflow Review
• ICSR Case Processing Assessment
• Pharmacovigilance Documentation
• Common PV Interview Questions
• Pharmacovigilance Career Pathways