Justina (Director, Acadustri (Medical Writing) Ltd and Visiting Lecturer, University of Hertfordshire, UK) Orleans-Lindsay
Meer over de auteurs
Justina (Director, Acadustri (Medical Writing) Ltd and Visiting Lecturer, University of Hertfordshire, UK) Orleans-Lindsay,
J Orleans–Lindsay
John Wiley & Sons
e druk, 2012
9781119967262
Pharmacovigilance Medical Writing – A Good Practice Guide
A Good Practice Guide
Specificaties
Paperback, 286 blz.
|
Engels
John Wiley & Sons |
e druk, 2012
ISBN13: 9781119967262
Rubricering
Levertijd ongeveer 8 werkdagen
Samenvatting
Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post–marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.
Specificaties
Inhoudsopgave
<p>Preface Pharmacovigilance Medical Writing Comes of Age ix</p>
<p>Acknowledgements xiii</p>
<p>Abbreviations xv</p>
<p>1 Pharmacovigilance Medical Writing An Overview Across the Drug Development Process 1</p>
<p>2 Pharmacovigilance Medical Writing for Clinical Trials 5</p>
<p>2.1 Introduction 5</p>
<p>2.2 The EU Annual Safety Report and US IND Annual Report A Historical Look at Reporting from Clinical Studies 6</p>
<p>2.3 The Development Safety Update Report 9</p>
<p>2.4 References 30</p>
<p>3 Pharmacovigilance Medical Writing for Marketing Authorization 33</p>
<p>3.1 Introduction 33</p>
<p>3.2 The Summary of Clinical Safety 34</p>
<p>3.3 The Integrated Summary of Safety 60</p>
<p>3.4 The 120–Day Safety Update Report 73</p>
<p>3.5 References 74</p>
<p>4 Pharmacovigilance Medical Writing in Risk Evaluation and Management 75</p>
<p>4.1 Introduction 75</p>
<p>4.2 The EU Risk Management Plan 76</p>
<p>4.3 The Risk Evaluation and Mitigation Strategies Report 96</p>
<p>4.4 The Benefit–Risk Evaluation Report 106</p>
<p>4.5 References 114</p>
<p>5 Pharmacovigilance Medical Writing for Marketed Products 117</p>
<p>5.1 Introduction 117</p>
<p>5.2 The EU Periodic Safety Update Report 119</p>
<p>5.3 The US Periodic Adverse Drug Experience Report 147</p>
<p>5.4 The PSUR Addendum Report 157</p>
<p>5.5 The Summary Bridging Report 163</p>
<p>5.6 References 169</p>
<p>6 The Ad–Hoc Safety Review and Response to Questions Document 171</p>
<p>6.1 Introduction 171</p>
<p>6.2 The Ad–Hoc Safety Review 172</p>
<p>6.3 The Response to Questions Document 179</p>
<p>7 The Rest of the World 185</p>
<p>7.1 Introduction 185</p>
<p>7.2 Japan 186</p>
<p>7.3 Canada 188</p>
<p>7.4 Australia and New Zealand 188</p>
<p>7.5 India 189</p>
<p>7.6 Singapore and Taiwan 190</p>
<p>7.7 References 191</p>
<p>Appendices</p>
<p>Appendix 1: Sample Line Listing 193</p>
<p>Appendix 2: Sample Summary Tabulation 197</p>
<p>Appendix 3: Another Look at the US IND Annual Report 199</p>
<p>Appendix 4: The New Pharmacovigilance Legislation in the EU 211</p>
<p>Appendix 5: The New EU Risk Management Plan 215</p>
<p>Appendix 6: The New EU Periodic Safety Update Report/Periodic Benefit–Risk Evaluation Report 227</p>
<p>Glossary 253</p>
<p>Index 259</p>
<p>Acknowledgements xiii</p>
<p>Abbreviations xv</p>
<p>1 Pharmacovigilance Medical Writing An Overview Across the Drug Development Process 1</p>
<p>2 Pharmacovigilance Medical Writing for Clinical Trials 5</p>
<p>2.1 Introduction 5</p>
<p>2.2 The EU Annual Safety Report and US IND Annual Report A Historical Look at Reporting from Clinical Studies 6</p>
<p>2.3 The Development Safety Update Report 9</p>
<p>2.4 References 30</p>
<p>3 Pharmacovigilance Medical Writing for Marketing Authorization 33</p>
<p>3.1 Introduction 33</p>
<p>3.2 The Summary of Clinical Safety 34</p>
<p>3.3 The Integrated Summary of Safety 60</p>
<p>3.4 The 120–Day Safety Update Report 73</p>
<p>3.5 References 74</p>
<p>4 Pharmacovigilance Medical Writing in Risk Evaluation and Management 75</p>
<p>4.1 Introduction 75</p>
<p>4.2 The EU Risk Management Plan 76</p>
<p>4.3 The Risk Evaluation and Mitigation Strategies Report 96</p>
<p>4.4 The Benefit–Risk Evaluation Report 106</p>
<p>4.5 References 114</p>
<p>5 Pharmacovigilance Medical Writing for Marketed Products 117</p>
<p>5.1 Introduction 117</p>
<p>5.2 The EU Periodic Safety Update Report 119</p>
<p>5.3 The US Periodic Adverse Drug Experience Report 147</p>
<p>5.4 The PSUR Addendum Report 157</p>
<p>5.5 The Summary Bridging Report 163</p>
<p>5.6 References 169</p>
<p>6 The Ad–Hoc Safety Review and Response to Questions Document 171</p>
<p>6.1 Introduction 171</p>
<p>6.2 The Ad–Hoc Safety Review 172</p>
<p>6.3 The Response to Questions Document 179</p>
<p>7 The Rest of the World 185</p>
<p>7.1 Introduction 185</p>
<p>7.2 Japan 186</p>
<p>7.3 Canada 188</p>
<p>7.4 Australia and New Zealand 188</p>
<p>7.5 India 189</p>
<p>7.6 Singapore and Taiwan 190</p>
<p>7.7 References 191</p>
<p>Appendices</p>
<p>Appendix 1: Sample Line Listing 193</p>
<p>Appendix 2: Sample Summary Tabulation 197</p>
<p>Appendix 3: Another Look at the US IND Annual Report 199</p>
<p>Appendix 4: The New Pharmacovigilance Legislation in the EU 211</p>
<p>Appendix 5: The New EU Risk Management Plan 215</p>
<p>Appendix 6: The New EU Periodic Safety Update Report/Periodic Benefit–Risk Evaluation Report 227</p>
<p>Glossary 253</p>
<p>Index 259</p>