Preface

The book "Pharmacovigilance" describes the pathway to understand that pharmacovigilance plays a specialized and pivotal role in ensuring ongoing safety of medicinal products. Written in plain English, the book is concise, jargon-free, facilitates an understanding of the fundamentals of pharmacovigilance, and explores regulatory aspects involved in pharmacovigilance.

Consuming a drug is equivalent to consuming a risk. It is only when the benefit associated with the drug is more than the risk, that the consumption of a drug is justified. Thus, it is the benefit versus risk ratio of the drug that decides whether a drug is to be taken or not. The next question is how to measure risks and how to measure benefits. Due to individualization of drugs to patients, it is the clinical judgment of the physician to identify what will benefit the observations related to Pharmacovigilance. The studies related to Pharmacovigilance indicate the possible risks associated with the drug.

Pharmacovigilance is an emerging area for employment in recent years. Information and in-depth knowledge of drugs is an advantage for anybody who wants to make career in this field. Hence, pharmacists are well suited to exploit the opportunity. The job potential is both local as well as global. Opportunities are enormous, one only has to make a commitment for the career.

Authors have tried to make the contents of the book more informative and inclusive; however, for an ever-changing field such as Pharmacovigilance, updates are probably a daily affair. Authors have attempted to make the content inclusive; however, comments are welcome.

> **Charmy Kothari** Institute of Pharmacy, Nirma University, Ahmedabad

> **Manan Shah** Institute of Pharmacy, Nirma University, India

> **Rajvi Manthan Patel** Institute of Pharmacy, Nirma University, India

**1**

Section 1

Basics of

Pharmacovigilance

Section 1
