MODULE 1

Introduction to Pharmacovigilance

• Definition and Scope of Pharmacovigilance
• History and Importance of Pharmacovigilance

MODULE 2

Regulatory Aspects in Pharmacovigilance

• International Pharmacovigilance Guidelines (ICH, WHO)
• Regulatory Requirements in the US, EU, and globally

MODULE 3

Adverse Drug Reactions (ADRs)

• Types and Mechanisms of ADRs
• Detection and Reporting of ADRs

MODULE 4

Pharmacovigilance Systems and Processes

• Data Collection and Management
• Signal Detection and Management

MODULE 5

Risk Assessment and Mitigation

• Risk Management Plans
• Strategies for Minimizing Drug Risks

MODULE 6

Pharmacovigilance and Public Health

• Role in Public Health
• Vaccine Safety and Pharmacovigilance

MODULE 7

Quality Assurance in Pharmacovigilance

• Auditing and Inspections
• Best Practices in Pharmacovigilance

MODULE 8

Case Studies and Real-world Pharmacovigilance

• Discussing Real-world Scenarios
• Lessons Learned from Past Drug Safety Issues