Pharmacovigilance Medical Writing: A Good Practice Guide

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Justina Orleans-Lindsay (Director, Acadustri (Medical Writing) Ltd and Visiting Lecturer, University of Hertfordshire, UK)

Pharmacovigilance Medical Writing

A Good Practice Guide

Justina Orleans-Lindsay (Director, Acadustri (Medical Writing) Ltd and Visiting Lecturer, University of Hertfordshire, UK)

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English

Wiley-Blackwell
27 July 2012

Pharmacology

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.

By: Justina Orleans-Lindsay (Director Acadustri (Medical Writing) Ltd and Visiting Lecturer University of Hertfordshire UK)
Imprint: Wiley-Blackwell
Country of Publication: United Kingdom
Dimensions: Height: 216mm, Width: 140mm, Spine: 14mm
Weight: 308g
ISBN: 9781119967262
ISBN 10: 1119967260
Pages: 288
Publication Date: 27 July 2012
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

Justina Orleans-Lindsay BSc, MSc, PhD is a Director of Acadustri (Medical Writing) Limited and Visiting Lecturer in pharmacovigilance at the University of Hertfordshire, UK.

Reviews for Pharmacovigilance Medical Writing: A Good Practice Guide

?This book is well structured and should prove useful for pharmacovigilance scientists and writers to have a reference text and checklist for regulatory pharmacovigilance documentation requirements.? (Pharmaceutical Journal, 9 February 2013)