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

Medical Writing


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Author by : Neville W. Goodman
Languange Used : en
Release Date : 2006-10-26
Publisher by : Cambridge University Press

Effective communication is the ultimate, but often daunting, purpose of any piece of medical research. Medical

Practical Aspects Of Signal Detection In Pharmacovigilance


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Author by :
Languange Used : en
Release Date : 2010
Publisher by : Cioms

In recent years public expectations for rapid identification and prompt management of emerging drug safety iss

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

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