Pharmacovigilance Medical Writing: A Good Practice Guide [Paperback]

Justina Orleans-Lindsay (Author)

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Product details

Paperback: 312 pages
Publisher: Wiley-Blackwell; 1 edition (10 Aug 2012)
Language English
ISBN-10: 1119967260
ISBN-13: 978-1119967262
Amazon Bestsellers Rank: 1,956,835 in Books (See Top 100 in Books)

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Product 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.

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