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Pharmacovigilance Medical Writing - A Good Practice Guide

Language EnglishEnglish
Book Paperback
Book Pharmacovigilance Medical Writing - A Good Practice Guide Justina Orleans-Lindsay
Libristo code: 01401996
Publishers John Wiley and Sons Ltd, July 2012
Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stag... Full description
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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.

About the book

Full name Pharmacovigilance Medical Writing - A Good Practice Guide
Author Justina Orleans-Lindsay
Language English
Binding Book - Paperback
Date of issue 2012
Number of pages 286
EAN 9781119967262
ISBN 1119967260
Libristo code 01401996
Publishers John Wiley and Sons Ltd
Weight 312
Dimensions 137 x 216 x 13

Categories

Medicine & Nursing > Medical specialties, branches of medicine > Pharmacology
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