Pharmacovigilance Medical Writing: A Good Practice Guide

Pharmacovigilance Medical Writing: A Good Practice Guide

Author(s): Justina Orleans-Lindsay

Published Online: 19 JUN 2012 08:48PM EST

Print ISBN: 9781119967262

Online ISBN: 9781118301906

DOI: 10.1002/9781118301906

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.

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