Pharmacovigilance Medical Writing

A Good Practice Guide

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Pharmacovigilance Medical Writing by Justina Orleans-Lindsay, Wiley
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Author: Justina Orleans-Lindsay ISBN: 9781118302064
Publisher: Wiley Publication: June 22, 2012
Imprint: Wiley-Blackwell Language: English
Author: Justina Orleans-Lindsay
ISBN: 9781118302064
Publisher: Wiley
Publication: June 22, 2012
Imprint: Wiley-Blackwell
Language: English

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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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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