Main description:

All the chapters have been updated in this second edition and new chapters like Pharmacoepidemiology and Pharmacovigilance, Hospitalization due to Adverse Drug Reactions and its Economic Burden, and Vigilance Systems for Medical Devices have been added.

This book will be useful for the healthcare professionals, postgraduate students, industry professionals and those engaged in clinical research at academia and the pharmaceutical industry.

Contents:

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