Elements of Pharmacovigilance by Raman Sehgal, Dr. Rajat Sethi and Dr. Shobha Rani Hiremath


The book is written by national and international team of outstanding contributors who have an excellent standing within the Pharmacovigilance community. It includes the latest theoretical and practical aspects of Pharmacovigilance and provides an exemplary coverage of all the relevant issues on drug safety. Some of the key topics discussed are:

  • Spontaneous Reporting - Dr. Shobha Rani R Hiremath (Bangalore, India)

  • Introductory Pharmacoepidemiology - Dr. Robert A Freeman & Dr. Rajat Sethi (Texas, USA)

  • Pharmacoeconomics and Outcomes Research: An Overview - Dr. Robert A Freeman & Dr. Rajat Sethi (Texas, USA)

  • Pharmacovigilance and Postmarket Surveillance in the United States: The Role of the USFDA - Dr. Laura M. Plunkett (Houston, USA)

  • Pharmacovigilance in Unani Medicine A Challenge -   Dr. Syed Zia Ur-Rahman (Aligarh, India)

  • Pharmacovigilance of Over the Counter Drugs - Dr. Sandeep Kaushal (Ludhiana, India)

  • The Current Scenario of Herbal Pharmacovigilance - Dr. P. Bigoniya (Bhopal, India)

  • Vaccine Pharmacovigilance - Dr. Mandeep Singh Dhingra (Hyderabad, India)

  • Pharmacovigilance: A Dental Perspective - Sohil A  Khan (Sydney, Australia)

  • Postmarketing Surveillance and PSURs - R. K. Rishi (Kolkata, India)

  • Medical Dictionary for Regulatory Activities - Raman Sehgal (New Delhi, India)

  • Biostatistical Aspects in Pharmacovigilance - Dr. Vrijesh Tripathi (Trinidad & Tobago, West Indies)

  • Medication Errors and Safe Use of Drugs - Dr. H. P. Tipnis (Mumbai, India)

  • Teaching in Pharmacovigilance - Dr. P. R. Shankar (Lalitpur, Nepal)

  • Teaching Pharmacovigilance: Therapeutic Drug Monitoring in the Curriculum Dr. Barry Bleidt and Dr. C. David Matthew (Texas, USA)

  • Hazards of Blood Transfusion - Dr. R.N. Makroo (New Delhi, India)

  • Risk Assessment & Management - Dr. Bikas Medhi (Chandigarh, India)

  • ADRs and Anti-Epileptic Drugs Dr. Nidhi Agarwal (New Delhi, India)

  • Integrated Safety Platform - Role of Information Technology - Partha Chakraborty (Bangalore, India)


Some Comments from around the World


"This book examines the many elements of phamacovigilance in a very methodical and comprehensive manner. It is an accessible textbook which is perfect for beginners as it starts with the basics. Inclusion of new chapters including Pharmacovigilance of vaccines and Unani medicines, hazard of blood transfusion, safety of dental products makes it even more interesting. It will serve as an excellent resource for any professional, new or experienced, working in drug safety” Dr. Yatin Shivkar, Pharmacovigilance Physician, United Kingdom.


“This book provides perspectives in phamacovigilance in a concise manner and is a recommended read for all aspiring phamacovigilance professionals.” Dr. Vishal Goyal, Clinical Specialist, Medical Affairs, Baxter India Pvt. Ltd.


“Easy to read and informative!!” Suhail Ali, Global Study Manager, GlaxoSmithKline Pte. Ltd., Singapore


“With the proliferation and use of drugs across the world, this timely book is of great educational value to a national and international audience that is concerned about maintaining the quality of patient care in today's world and eliminating the risks of drug use in the treatment and control of diseases. I recommend the Elements of Pharmacovigilance as a must read!” Dr. Guadalupe Reyes, Jr., Director of the Texas A&M Health Science Center, Coastal Bend Health Education Center, USA.

"The much awaited and worth reading.It will serve a good reference for both novice and experienced phamacovigilance professionals" Irshad-Ul-Haque, Associate Director, Medpace Clinical Research India Pvt. Ltd.


“This is a must read for anyone involved in the field of pharmacovigilance. The book does an excellent job in reviewing the current developments in this field”. Dr. Thomas Alexander, Medical Director, CHRISTUS Spohn Hospital, Shoreline Chest Pain Center and Chair of Corpus Christi Cardiovascular Management for the Health System, USA.



Foreword By:

Dr. Mansoor Khan (CDER, USFDA)
Mr. Kapil Bhargava (Ex-Deputy Drugs Controller, India)



Messages By:

Dr. Harpal Buttar (Health Canada)
Dr. Nilima Kshirsagar (Acting Vice Chancellor, MUHS, Nashik)
Dr. Gamal Hussein (Loma Linda University, USA)
Dr. Richard Kennedy (Loyola University Medical Center, USA)



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