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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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.


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