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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.
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
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...