Pharmacovigilance Medical Writing A Good Practice Guide

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.

ISBN:	9781119967262
Publisher:	Wiley
Imprint:	Wiley Blackwell
Published date:	27 Jul 2012
DEWEY:	615.4
DEWEY edition:	23
Language:	English
Number of pages:	269
Weight:	312g
Height:	216mm
Width:	137mm
Spine width:	13mm

Write a review

Your Name:

Your Review: Note: HTML is not translated!

Rating: Bad           Good

Enter the code in the box below: