Pharmacovigilance for B.Pharm VIII Sem is designed specifically for B.Pharm students, and it aligns with the Pharmacy Council of India’s (PCI) curriculum guidelines for the VIII semester an in-depth understanding of pharmacovigilance.
An essential component of pharmaceutical sciences that focuses on monitoring and improving drug safety. This book provides a clear introduction to the development of pharmacovigilance as a scientific field, covering essential concepts such as terminology, global pharmacovigilance frameworks, and various methods of generating safety data and signal detection.
Features
• Comprehensive Coverage – Explores pharmacovigilance history, terminology, and global regulations.
• Practical Insights – Details signal detection, clinical trials, and post-marketing surveillance.
• Structured Approach – Organized into five focused units: Pharmacovigilance, Drug & Disease Classification, Safety Data & ICH Guidelines, Clinical Trials, and Pharmacogenomics & CIOMS.

Whether you are student, educator or industry professional, this book offers a clear, practical guide to drug safety and regulatory practices.

• Introduction
• Introduction to Adverse Drug Reactions
• Basic Terminologies Used in Pharmacovigilance
• Drug and Disease Classification
• Drug Dictionaries and Coding in Pharmacovigilance
• Information Resources in Pharmacovigilance
• Establishing Pharmacovigilance Programme
• Vaccine Safety Surveillance
• Pharmacovigilance Methods
• Communication in Pharmacovigilance
• Safety Data Generation
• ICH Guidelines for Pharmacovigilance
• Pharmacogenomic of ADRs
• Drug Safety Evaluation in Special Population
• CIOMS
• CDSCO (India) and Pharmacovigilance