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<p>Acknowledgements ix</p> <p>Foreword x</p> <p>Preface xii<br /><br /><b>Chapter 1 What is pharmacovigilance and how has it developed? 1</b></p> <p>Origins and definition of pharmacovigilance 1</p> <p>Scope and purposes of pharmacovigilance 3</p> <p>Development of pharmacovigilance since the 1960s 5</p> <p>Conclusion 14</p> <p><b>Chapter 2 Basic concepts 15</b></p> <p>Introduction 15</p> <p>Adverse drug reactions 15</p> <p>The concept of safety 21</p> <p>Causation – was the drug responsible? 25</p> <p>Conclusion 29</p> <p><b>Chapter 3 Types and sources of data 30</b></p> <p>Introduction 30</p> <p>Pre-clinical studies 30</p> <p>Human volunteer studies 31</p> <p>Clinical trials 31</p> <p>Post-marketing surveillance 33</p> <p>Systematic reviews and meta-analysis 42</p> <p>Conclusion 43</p> <p><b>Chapter 4 The process of pharmacovigilance 44</b></p> <p>Overview – a risk management process 44</p> <p>Signal detection 44</p> <p>Evaluation and investigation 50</p> <p>Taking action 52</p> <p>Communication 56</p> <p>Crisis management 59</p> <p>Conclusion 60</p> <p><b>Chapter 5 Regulatory aspects of pharmacovigilance 61</b></p> <p>Introduction 61</p> <p>Legislation and guidelines 62</p> <p>Regulatory pharmacovigilance systems 64</p> <p>Obligations of pharmaceutical companies 65</p> <p>Risk management planning 69</p> <p>Conclusion 73</p> <p><b>Chapter 6 International collaboration 74</b></p> <p>Introduction 74</p> <p>World Health Organisation 75</p> <p>Council for the Organisation of Medical Sciences 75</p> <p>International Conference on Harmonisation 78</p> <p>Conclusion 79</p> <p><b>Chapter 7 Ethical and societal considerations 80</b></p> <p>Introduction 80</p> <p>Stakeholders and their perspectives 80</p> <p>Ethical principles 83</p> <p>Ethical safeguards in relation to safety 84</p> <p>Transparency 85</p> <p>Conflicts of interest 86</p> <p>Conclusion 87</p> <p><b>Chapter 8 Future directions 89</b></p> <p>Introduction—current limitations 89</p> <p>Meeting the challenges 90</p> <p>Conclusion 93</p> <p><b>Chapter 9 Learning more about pharmacovigilance 94</b></p> <p>Books 94</p> <p>Journals 95</p> <p>Useful websites 95</p> <p>Courses 96</p> <p>International societies 96</p> <p>Conclusion 96</p> <p>Glossary 98</p> <p>Index 101</p>

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.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. <p>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.</p> <p>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.</p>

GB