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.

Download Now Read Online

Pharmacovigilance Medical Writing


Download Now Read Online

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

Drug Safety Data


Download Now Read Online

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

Mann S Pharmacovigilance


Download Now Read Online

Author by : Elizabeth B. Andrews
Languange Used : en
Release Date : 2014-06-23
Publisher by : Wiley-Blackwell

Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding

Cobert S Manual Of Drug Safety And Pharmacovigilance


Download Now Read Online

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.

Targeted Regulatory Writing Techniques Clinical Documents For Drugs And Biologics


Download Now Read Online

Author by : Linda Fossati Wood
Languange Used : en
Release Date : 2009-01-05
Publisher by : Springer Science & Business Media

This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documen

Drug Discovery And Clinical Research


Download Now Read Online

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

Bad Pharma


Download Now Read Online

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 $

Leave a Reply