Pharmacovigilance Medical Writing

Ebook

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


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Author by : Justina Orleans-Lindsay
Languange Used : en
Release Date : 2012-06-22
Publisher by : John Wiley & Sons

Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the

Mann S Pharmacovigilance


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Author by : Elizabeth B. Andrews
Languange Used : en
Release Date : 2014-03-24
Publisher by : John Wiley & Sons

Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference fo

Drug Safety Data


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Author by : Michael J. Klepper
Languange Used : en
Release Date : 2010-10-25
Publisher by : Jones & Bartlett Learning

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinica

Cobert S Manual Of Drug Safety And Pharmacovigilance


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Author by : Barton Cobert
Languange Used : en
Release Date : 2011-04-01
Publisher by : Jones & Bartlett Publishers

Rev. ed. of: Manual of drug safety and pharmacovigilance / Barton L. Cobert. c2007.

Bad Pharma


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Author by : Ben Goldacre
Languange Used : en
Release Date : 2013-02-05
Publisher by : Signal

We all feel uncomfortable about the role of profit in healthcare, we all have a vague notion that the global $

Drug Discovery And Clinical Research


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Author by : SK Gupta
Languange Used : en
Release Date : 2011-06-01
Publisher by : JP Medical Ltd

The Drug Discovery and Clinical Research bandwagon has been joined by scientists and researchers from all fiel

Medical Pharmacology And Therapeutics


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Author by : Derek G. Waller
Languange Used : en
Release Date : 2013-08-07
Publisher by : Elsevier Health Sciences

This book covers all the pharmacology you need, from basic science pharmacology and pathophysiology, through t

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