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Pharmacovigilance Medical Writing: A Good Practice Guide by Justina Orleans-Lindsay (Paperback, 2012)

About this product

About this product

Product Information

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.

Product Identifiers

Publisher
John Wiley and Sons Ltd
ISBN-13
9781119967262
eBay Product ID (ePID)
114831444

Product Key Features

Author
Justina Orleans-Lindsay
Publication Name
Pharmacovigilance Medical Writing: a Good Practice Guide
Format
Paperback
Language
English
Subject
Medicine
Publication Year
2012
Type
Textbook
Number of Pages
286 Pages

Dimensions

Item Height
215mm
Item Width
137mm
Item Weight
312g

Additional Product Features

Title_Author
Justina Orleans-Lindsay
Country/Region of Manufacture
United States

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