دانلود کتاب Pharmacovigilance Medical Writing: A Good Practice Guide

توضیحاتی در مورد کتاب به زبان اصلی :

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):