Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
Author :
Publisher : Springer Science & Business Media
Total Pages : 235
Release :
ISBN-10 : 9783764383626
ISBN-13 : 3764383623
Rating : 4/5 (26 Downloads)

Book Synopsis Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics by : Linda Fossati Wood

Download or read book Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics written by Linda Fossati Wood and published by Springer Science & Business Media. This book was released on 2009-01-05 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics Related Books

Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
Language: en
Pages: 235
Authors: Linda Fossati Wood
Categories: Medical
Type: BOOK - Published: 2009-01-05 - Publisher: Springer Science & Business Media

DOWNLOAD EBOOK

This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundam
Publishing and Presenting Clinical Research
Language: en
Pages: 227
Authors: Warren S. Browner
Categories: Medical
Type: BOOK - Published: 2012-03-19 - Publisher: Lippincott Williams & Wilkins

DOWNLOAD EBOOK

Publishing and Presenting Clinical Research, Fourth Edition is an excellent primer for investigators who wish to learn how to organize, present, and publish res
Modern Methods of Drug Discovery
Language: en
Pages: 314
Authors: Alexander Hillisch
Categories: Medical
Type: BOOK - Published: 2002-12-11 - Publisher: Springer Science & Business Media

DOWNLOAD EBOOK

Research in the pharmaceutical industry today is in many respects quite different from what it used to be only fifteen years ago. There have been dramatic chang
Clinical Research and the Law
Language: en
Pages: 295
Authors: Patricia M. Tereskerz
Categories: Medical
Type: BOOK - Published: 2012-05-07 - Publisher: John Wiley & Sons

DOWNLOAD EBOOK

This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses lega
New Drug Development
Language: en
Pages: 216
Authors: Mark P. Mathieu
Categories: Medical
Type: BOOK - Published: 1987 - Publisher: Omec

DOWNLOAD EBOOK