An Introduction to Pharmacovigilance [NOOK Book]

Overview

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...

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An Introduction to Pharmacovigilance

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Overview

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 as well as for pharmaceutical medicine students.

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Product Details

  • ISBN-13: 9781444359213
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 8/24/2011
  • Sold by: Barnes & Noble
  • Format: eBook
  • Edition number: 5
  • Pages: 120
  • File size: 763 KB

Meet the Author

Dr Patrick Waller has been an independent consultant in pharmacovigilance and pharmacoepidemiology based in Southampton since 2002. He also holds honorary academic appointments at the London School of Hygiene and Tropical Medicine and the University of Dundee.  From 1998-2004 he was Visiting Professor in the Department of Pharmacological Sciences at the University of Newcastle-upon-Tyne.  From 1990-2002 he worked in the field of pharmacovigilance for the Medicines Control Agency in London. From 1998-2000 he was one of the UK delegates to the Committee for Proprietary Medicinal Products and Chairman of its Pharmacovigilance Working Party.
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Table of Contents

Ch. 1 What is pharmacovigilance and how has it developed? 1

Ch. 2 Basic concepts 15

Ch. 3 Types and sources of data 30

Ch. 4 The process of pharmacovigilance 44

Ch. 5 Regulatory aspects of pharmacovigilance 61

Ch. 6 International collaboration 74

Ch. 7 Ethical and societal considerations 80

Ch. 9 Learning more about pharmacovigilance 94

Glossary 98

Index 101

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