Pharmacovigilance Medical Writing: A Good Practice Guide
Copyright © 2012 John Wiley & Sons, Ltd
Author(s): Justina Orleans-Lindsay
Published Online: 19 JUN 2012 08:48PM EST
Print ISBN: 9781119967262
Online ISBN: 9781118301906
About this Book
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.