Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics PDF
By:Linda Fossati Wood,MaryAnn Foote
Published on 2009-01-05 by Springer Science & Business Media
This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.
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Book ID of Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics's Books is XrzEBAAAQBAJ, Book which was written byLinda Fossati Wood,MaryAnn Footehave ETAG "NSjjt/Bf7TE"
Book which was published by Springer Science & Business Media since 2009-01-05 have ISBNs, ISBN 13 Code is 9783764383626 and ISBN 10 Code is 3764383623
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Book which have "238 Pages" is Printed at BOOK under CategoryMedical
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