Pharmacovigilance Medical Writing
Author : Justina Orleans-Lindsay
Publisher : John Wiley & Sons
Total Pages : 288
Release : 2012-06-22
ISBN 10 : 9781118302064
ISBN 13 : 1118302060
Language : EN, FR, DE, ES & NL

Pharmacovigilance Medical Writing Book 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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Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical devel
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