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Orleans-Lindsay, Justina

Pharmacovigilance Medical Writing: A Good Practice Guide

Orleans-Lindsay, Justina - Pharmacovigilance Medical Writing: A Good Practice Guide, e-bok

39,80€

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ISBN: 9781118302057
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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.

Nyckelord: Clinical Pharmacology & Therapeutics

Författare
Utgivare
John Wiley and Sons, Inc.
Utgivningsår
2012
Språk
en
Utgåva
2
Sidantal
288 sidor
Kategori
Hälsa, skönhet, mode
Format
E-bok
eISBN (PDF)
9781118302057
Tryckt ISBN
9781119967262

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