Pharmacovigilance Medical Writing. a Good Practice Guide

Description

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.

Table of Contents

• Foreword
• Preface : Pharmacovigilance Medical Writing Comes of Age
• Acknowledgements
• Abbreviations

1. Pharmacovigilance Medical Writing: An Overview Across the Drug Development Process
2. Pharmacovigilance Medical Writing for Clinical Trials
1. Introduction
2. The EU Annual Safety Report and US IND Annual Report – A Historical Look at Reporting from Clinical Studies
3. The Development Safety Update Report
4. References
3. Pharmacovigilance Medical Writing for CTD Submissions
1. Introduction
2. The Summary of Clinical Safety
3. The Integrated Summary of Safety
4. The 120-Day Safety Update Report
5. References
4. Pharmacovigilance Medical Writing in Risk Evaluation & Management
1. Introduction
2. The EU Risk Management Plan
3. The Risk Evaluation and Mitigations Strategies Report
4. The Benefit-Risk Evaluation Report
5. References
5. Pharmacovigilance Medical Writing for Marketed Products
1. Introduction
2. The EU Periodic Safety Update Report
3. The US Periodic Adverse Drug Experience Report
4. The PSUR Addendum Report
5. The Summary Bridging Report
6. References
6. The Ad-Hoc Safety Review & Response to Questions Document
1. Introduction
2. The Ad-Hoc Safety Review
3. The Response to Questions Document
7. The Rest of the World
1. Introduction
2. Japan
3. Canada
4. Australia & New Zealand
5. India
6. Singapore & Taiwan
7. References

• Appendix: 2012 updates to The EU Risk Management Plan and The EU Periodic Safety Update Report
• Glossary
• Index