Pharmacovigilance Medical Writing: A Good Practice Guide

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en Limba Engleză Paperback – 27 Jul 2012
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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ISBN-13: 9781119967262
ISBN-10: 1119967260
Pagini: 286
Ilustrații: Illustrations
Dimensiuni: 137 x 215 x 14 mm
Greutate: 0.3 kg
Ediția: 0002
Editura: Wiley
Locul publicării: Chichester, United Kingdom

Public țintă

This book will be used by those working in drug safety and pharmacovigilance departments within pharmaceutical companies, biotechnology companies and contract research organisations, and as consultant/freelance medical writers and pharmacovigilance professionals. 

It will also be relevant for postgraduate students undertaking courses in pharmacovigilance, pharmacoepidemiology and pharmaceutical medicine, including the new Eu2P course.