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 new edition of a clear and succinct yet comprehensive guide to the field provides exactly the right introduction for those new to the challenges and the excitement of pharmacovigilance. It conveys the importance to public health protection of an effective safety net to pick up new information, and the need for well-planned strategies to generate new evidence as an enabler of innovation." -From the Foreword by Dr June Raine CBE, Director of Vigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UK and Chair of the EU Pharmacovigilance Risk Assessment Committee. Praise for the first edition
"The book is small in size, attractively produced, and... accessible to all. It does not assume any prior knowledge, yet it also manages to be informative for those who are already familiar with pharmacovigilance. I strongly recommend anyone involved with any type of post-marketing medication research, or any epidemiological study which includes medication use, to read this interesting little book." -C. Ineke Neutel, University of Ottawa (Annals of Epidemiology, December 2010)
Inhaltsverzeichnis
Foreword ix
Preface to the Second Edition xi
Preface to the First Edition xiii
Acknowledgements xv
List of Abbreviations xvii
1 What is Pharmacovigilance and How Has it Developed? 1
2 Basic Concepts 19
3 Types and Sources of Data 37
4 The Process of Pharmacovigilance 55
5 Regulatory Aspects of Pharmacovigilance 75
6 International Collaboration 95
7 Clinical Aspects of Adverse Drug Reactions 109
8 Ethical and Societal Considerations 123
9 Future Directions 135
10 Learning More About Pharmacovigilance 145
Glossary 151
Index 157
