Pharmacovigilance Medical Writing

Pharmacovigilance Medical Writing Author : Justina Orleans-Lindsay
Publisher : John Wiley & Sons
Pub Date : 2012-06-22
Page : 288
Language : en
Rating :



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 A Good Practice Guide

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Pharmacovigilance Medical Writing A Good Practice Guide Author Justina Orleans Lindsay Published On August 2012

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Pharmacovigilance Medical Writing A Good Practice Guide 2nd Second Edition By Orleans Lindsay Justina Published By Wiley Blackwell 2012

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Pharmacovigilance Medical Writing A Good Practice Guide By Justina Orleans Lindsay 27 Jul 2012 Paperback

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Publisher by : Wiley-Blackwell; 1 edition (27 July 2012)






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