"This book is well structured and should prove useful for pharmacovigilance scientists and writers to have a reference text and checklist for regulatory pharmacovigilance documentation requirements." (Pharmaceutical Journal, 9 February 2013)
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.
Pharmacovigilance Medical Writing covers thepreparation of pharmacovigilance documents for all stages of thedrug development process (i.e. from clinical development through toapplications for marketing authorisations to the post-marketingstage). For each document, the book presents a review of theregulatory 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 ageneric model document compliant with the current guidelines, whichcan be modified to meet specific company and product requirements.
Preface - Pharmacovigilance Medical Writing Comes of Age ix
Acknowledgements xiii
Abbreviations xv
1 Pharmacovigilance Medical Writing - An Overview Across the Drug Development Process 1
2 Pharmacovigilance Medical Writing for Clinical Trials 5
2.1 Introduction 5
2.2 The EU Annual Safety Report and US IND Annual Report - A Historical Look at Reporting from Clinical Studies 6
2.3 The Development Safety Update Report 9
2.4 References 30
3 Pharmacovigilance Medical Writing for Marketing Authorization 33
3.1 Introduction 33
3.2 The Summary of Clinical Safety 34
3.3 The Integrated Summary of Safety 60
3.4 The 120-Day Safety Update Report 73
3.5 References 74
4 Pharmacovigilance Medical Writing in Risk Evaluation and Management 75
4.1 Introduction 75
4.2 The EU Risk Management Plan 76
4.3 The Risk Evaluation and Mitigation Strategies Report 96
4.4 The Benefit-Risk Evaluation Report 106
4.5 References 114
5 Pharmacovigilance Medical Writing for Marketed Products 117
5.1 Introduction 117
5.2 The EU Periodic Safety Update Report 119
5.3 The US Periodic Adverse Drug Experience Report 147
5.4 The PSUR Addendum Report 157
5.5 The Summary Bridging Report 163
5.6 References 169
6 The Ad-Hoc Safety Review and Response to Questions Document 171
6.1 Introduction 171
6.2 The Ad-Hoc Safety Review 172
6.3 The Response to Questions Document 179
7 The Rest of the World 185
7.1 Introduction 185
7.2 Japan 186
7.3 Canada 188
7.4 Australia and New Zealand 188
7.5 India 189
7.6 Singapore and Taiwan 190
7.7 References 191
Appendices
Appendix 1: Sample Line Listing 193
Appendix 2: Sample Summary Tabulation 197
Appendix 3: Another Look at the US IND Annual Report 199
Appendix 4: The New Pharmacovigilance Legislation in the EU 211
Appendix 5: The New EU Risk Management Plan 215
Appendix 6: The New EU Periodic Safety Update Report/Periodic Benefit-Risk Evaluation Report 227
Glossary 253
Index 259
"This book is well structured and should prove useful forpharmacovigilance scientists and writers to have a reference textand checklist for regulatory pharmacovigilance documentationrequirements." ( Pharmaceutical Journal , 9February 2013)
Inhaltsverzeichnis
Preface - Pharmacovigilance Medical Writing Comes of Age ix
Acknowledgements xiii
Abbreviations xv
1 Pharmacovigilance Medical Writing - An Overview Across the Drug Development Process 1
2 Pharmacovigilance Medical Writing for Clinical Trials 5
2.1 Introduction 5
2.2 The EU Annual Safety Report and US IND Annual Report - A Historical Look at Reporting from Clinical Studies 6
2.3 The Development Safety Update Report 9
2.4 References 30
3 Pharmacovigilance Medical Writing for Marketing Authorization 33
3.1 Introduction 33
3.2 The Summary of Clinical Safety 34
3.3 The Integrated Summary of Safety 60
3.4 The 120-Day Safety Update Report 73
3.5 References 74
4 Pharmacovigilance Medical Writing in Risk Evaluation and Management 75
4.1 Introduction 75
4.2 The EU Risk Management Plan 76
4.3 The Risk Evaluation and Mitigation Strategies Report 96
4.4 The Benefit-Risk Evaluation Report 106
4.5 References 114
5 Pharmacovigilance Medical Writing for Marketed Products 117
5.1 Introduction 117
5.2 The EU Periodic Safety Update Report 119
5.3 The US Periodic Adverse Drug Experience Report 147
5.4 The PSUR Addendum Report 157
5.5 The Summary Bridging Report 163
5.6 References 169
6 The Ad-Hoc Safety Review and Response to Questions Document 171
6.1 Introduction 171
6.2 The Ad-Hoc Safety Review 172
6.3 The Response to Questions Document 179
7 The Rest of the World 185
7.1 Introduction 185
7.2 Japan 186
7.3 Canada 188
7.4 Australia and New Zealand 188
7.5 India 189
7.6 Singapore and Taiwan 190
7.7 References 191
Appendices
Appendix 1: Sample Line Listing 193
Appendix 2: Sample Summary Tabulation 197
Appendix 3: Another Look at the US IND Annual Report 199
Appendix 4: The New Pharmacovigilance Legislation in the EU 211
Appendix 5: The New EU Risk Management Plan 215
Appendix 6: The New EU Periodic Safety Update Report/Periodic Benefit-Risk Evaluation Report 227
Glossary 253
Index 259
Klappentext
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.
