Pharmacovigilance Medical Writing: A Good Practice Guide

✍ Scribed by Justina Orleans?Lindsay(auth.)

• Publisher: Wiley-Blackwell
• Year: 2012
• Tongue: English
• Leaves: 276
• Category: Library

✦ Synopsis

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.Content:
Chapter 1 Pharmacovigilance Medical Writing – An Overview Across the Drug Development Process (pages 1–4):
Chapter 2 Pharmacovigilance Medical Writing for Clinical Trials (pages 5–31):
Chapter 3 Pharmacovigilance Medical Writing for Marketing Authorization (pages 33–74):
Chapter 4 Pharmacovigilance Medical Writing in Risk Evaluation and Management (pages 75–115):
Chapter 5 Pharmacovigilance Medical Writing for Marketed Products (pages 117–170):
Chapter 6 The Ad?Hoc Safety Review and Response to Questions Document (pages 171–184):
Chapter 7 The Rest of the World (pages 185–192):