1. Key Definitions in Pharmacovigilance 2. Pharmacovigilance: Historical Perspective 3. Pharmacovigilance: Need and Objectives 4. Current Methods of Pharmacovigilance 5. Adverse Drug Reactions: Classification, Mechanism and Interaction 6. Signal Detection in Pharmacovigilance 7. Postmarketing Surveillance 8.

Setting up of a Pharmacovigilance Centre 9. Benefit-Risk Assessment in Pharmacovigilance 10. Crisis Management in Pharmacovigilance 11. WHO Pharmacovigilance: Programme for Global Drug Monitoring 12. Pharmacovigilance of Herbal Drugs 13. Medical Dictionary for Regulatory Activities: An Overview 14. Pharmacogenetics and Pharmacovigilance 15. Pharmacovigilance Regulations in Various Countries 16.

Pharmacoepidemiology and Pharmacovigilance 17. Hospitalization due to Adverse Drug Reactions and its Economic Burden 18. Vigilance Systems for Medical Devices 19. Data Mangement in Pharmacovigilance Annexures Index.