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Pharmacovigilance Medical Writing: A Good Practice Guide

Publication Year: 2012

Edition: 1st

Authors/Editor: Orleans-Lindsay, Justina

Publisher: Wiley

ISBN: 978-1-11-996726-2

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Description

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.

Details

Platform: Ovid
Publisher: Wiley
Product Type: Book
Author/Editor: Orleans-Lindsay, Justina
ISBN: 978-1-11-996726-2
Specialty:
Pharmaceutical Science
 Pharmacology
 Language: English
Edition: 1st
Pages: 286
Year: 2012
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