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Orleans-Lindsay, Justina

Pharmacovigilance Medical Writing: A Good Practice Guide

Orleans-Lindsay, Justina - Pharmacovigilance Medical Writing: A Good Practice Guide, ebook

39,80€

Ebook, PDF with Adobe DRM
ISBN: 9781118302057
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Printing86 pages with an additional page accrued every 9 hours, capped at 86 pages
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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.

Keywords: Clinical Pharmacology & Therapeutics

Author(s)
Publisher
John Wiley and Sons, Inc.
Publication year
2012
Language
en
Edition
2
Page amount
288 pages
Category
Medicine, Health Care, Mode
Format
Ebook
eISBN (PDF)
9781118302057
Printed ISBN
9781119967262

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