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An Introduction to Pharmacovigilance
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance.
Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.
This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance.
Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.
192 pages, ebook
First published September 22, 2009
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August 5, 2017
A good review of fundamental concepts in public health--particularly epidemiology--as they apply to pharmacovigilance.
The best parts of the book were the chapters on basic concepts, types and sources of data, the process of PV, and clinical aspects of PV. Found it especially interesting and useful to read about statistical methods applied to various strategies, ranging from meta analyses and prescription event monitoring, to signal detection using disproportionality approaches.
Did a good job of communicating clearly that signal detection is a screening function, requiring confirmation via subsequent drill down due diligence. Also enjoyed the discussions on communications and risk management planning.
The book would have benefited from having a glossary of acronyms, particularly for the chapter on regulatory aspects of pharmacovigilance. Too often, I found myself trying to track down what the acronym stood for, without recalling the page it's defined on.
Chapter on ethics and future direction were ok. The former was a bit trite and the latter offered little value added. Missed opportunities to truly highlight the cath-22 of the Helsinki declaration steering research away from vulnerable populations for safety reasons (i.e., pediatrics, pregnant patients) on the one hand, and on the other hand, the fact that the medical community is increasingly protesting the information disadvantage that we face wrt adverse drug events because clinical trials exclude these populations.
The best parts of the book were the chapters on basic concepts, types and sources of data, the process of PV, and clinical aspects of PV. Found it especially interesting and useful to read about statistical methods applied to various strategies, ranging from meta analyses and prescription event monitoring, to signal detection using disproportionality approaches.
Did a good job of communicating clearly that signal detection is a screening function, requiring confirmation via subsequent drill down due diligence. Also enjoyed the discussions on communications and risk management planning.
The book would have benefited from having a glossary of acronyms, particularly for the chapter on regulatory aspects of pharmacovigilance. Too often, I found myself trying to track down what the acronym stood for, without recalling the page it's defined on.
Chapter on ethics and future direction were ok. The former was a bit trite and the latter offered little value added. Missed opportunities to truly highlight the cath-22 of the Helsinki declaration steering research away from vulnerable populations for safety reasons (i.e., pediatrics, pregnant patients) on the one hand, and on the other hand, the fact that the medical community is increasingly protesting the information disadvantage that we face wrt adverse drug events because clinical trials exclude these populations.
Displaying 1 of 1 review