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Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

  • Book
  • © 2009

Overview

Editors:
  1. Linda Fossati Wood

    1. Medwrite Inc., Westford, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  2. MaryAnn Foote

    1. MA Foote Associates, Westlake Village, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  • Covers specific document types and submissions for drugs and biologics in the US, Japan and Europe. Extensive appendices of sample documents
  • Comprehensive glossary of terms
  • Written by two regulatory writers with more than 20 years experience each
  • Includes supplementary material: sn.pub/extras

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Table of contents (13 chapters)

  1. Front Matter

    Pages i-x
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  2. Regulatory writing fundamentals

    1. Front Matter

      Pages 1-1
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    2. Developing a target

      • Linda Fossati Wood
      Pages 3-23

  3. Getting started

    1. Front Matter

      Pages 25-25
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    2. Regulatory writing tips

      • Linda Fossati Wood
      Pages 27-32

    3. Templates and style guides: The nuts and bolts of regulatory documents

      • James Yuen, Debra L. Rood
      Pages 33-43

    4. Document review

      • Linda Fossati Wood, MaryAnn Foote
      Pages 45-50

  4. Source documents

    1. Front Matter

      Pages 51-51
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    2. Protocols

      • Linda Fossati Wood
      Pages 53-68

    3. Clinical study reports

      • Linda Fossati Wood
      Pages 69-102

  5. Integrated documents

    1. Front Matter

      Pages 103-103
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    2. Investigator’s brochures

      • Linda Fossati Wood
      Pages 105-119

    3. Investigational medicinal products dossier

      • Linda Fossati Wood
      Pages 121-124

    4. Integrated summaries of safety and efficacy

      • Jennifer A. Fissekis
      Pages 125-130

    5. Informed consent forms

      • Jennifer A. Fissekis
      Pages 131-137

  6. Regulatory submissions

    1. Front Matter

      Pages 139-139
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    2. Global submissions: The common technical document

      • Peggy Boe
      Pages 141-153

    3. Clinical trial procedures and approval processes in Japan

      • Takumi Ishida, Katsunori Kurusu
      Pages 155-174

    4. Region-specific submissions: United States of America

      • Linda Fossati Wood
      Pages 175-185

  7. Back Matter

    Pages 187-237
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Keywords

About this book

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.

Editors and Affiliations

  • Medwrite Inc., Westford, USA

    Linda Fossati Wood

  • MA Foote Associates, Westlake Village, USA

    MaryAnn Foote

Bibliographic Information

  • Book Title: Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

  • Editors: Linda Fossati Wood, MaryAnn Foote

  • DOI: https://doi.org/10.1007/978-3-7643-8362-6

  • Publisher: Birkhäuser Basel

  • eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)

  • Copyright Information: Birkh�user Basel 2009

  • Softcover ISBN: 978-3-7643-8361-9Published: 18 November 2008

  • eBook ISBN: 978-3-7643-8362-6Published: 05 January 2009

  • Edition Number: 1

  • Number of Pages: X, 238

  • Number of Illustrations: 26 b/w illustrations

  • Topics: Pharmacology/Toxicology, Biotechnology, Pharmacy

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