A Comprehensive Book of PHARMACOVIGILANCE For Pharmacy, Medical and Other Healthcare Courses | Preeti Singh, Dr. Shekhar Verma | Nirali Prakashan

1. Introduction of Pharmacovigilance
2. Drug Discovery and Safety Data Generation
3. Pharmacovigilance System in India : PvPI
4. Adverse Drug Reaction and its Management
5. Pharmacovigilance Plan
6. Basic Terminologies and Coding used in Pharmacovigilance
7. Basic Drug Information Resources
8. Establishing Pharmacovigilance Program
9. Communication in Pharmacovigilance
10. Council for International Organizations of Medical Sciences (CIOMS)
11. The International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use
12. Vaccine Safety Surveillance
13. The Materiovigilance Program of India
14. The Haemovigilance Program of India
15. Pharmacogenomics
16. Career Opportunities in Pharmacovigilance
Glossary
Index
Pharmacovigilince Reporting Forms

Pharmacovigilance is an exceptionally new topic withinside the healthcare system and pharmaceutical industry. It is a scientific discipline that explicitly focuses on improving patient safety, at the earliest with minimal patient risk and increasing the benefit/risk ratio of pharmaceutical & medical products. So, the principles governing the rational use of drugs should be communicated, learned and practiced by students, doctors, pharmacists, nurses,

other healthcare workers and patients in their daily clinical practice.

ADRs account for 5-10% of all hospital admissions, and ADRs represent the fifth most common cause of death in hospital settings. ADRs still pose many problems for patients and hence the healthcare system. These can be prevented as most of them are predictable through the knowledge of pharmacovigilance. The nation’s wealth can be improved by having a good quality of drug therapy as well as patient safety in all healthcare settings.

Pharmacovigilance is an admirable employment option for pharmacy, nursing, life science, and medical graduates. Pharmacovigilance professionals continuously monitor drug

safety in clinical trials and drugs that are already being marketed.

As a student and a teacher, the authors have gone through numerous books on pharmacovigilance that cover various disciplines with varying depths. Still, these books do not provide an integrated approach to the students that, in turn, lead the students and the teachers to refer to many books to understand overall principles. In order to bridge the existing gap, this book aims to serve as a comprehensive manual for all the

pharmacovigilance activities required during the post-marketing life of the product; and we have attempted to cover each topic thoroughly in one place to save time and workload. This

book Pharmacovigilance: A Comprehensive Approach will serve as a ready reference for Pharmacovigilance related activities.

This book will discuss important concepts related to drug development, various terminologies, guidelines and regulations for establishing pharmacovigilance, the importance of signal detection, ADRs reporting, and data mining. It also covers the different programs running in India like Pharmacovigilance Program of India (PvPI), Materiovigilance Program of India (MvPI), Haemovigilance Program of India (HvPI) and AEFI Surveillance Program.

It is envisioned to impart the basic principles and advancements of pharmacovigilance to students and professionals of Clinical Pharmacology and Pharmacovigilance through this book. It will benefit the undergraduate and postgraduate students of Medicine, Pharmacy, Nursing, and Dentistry.