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.
Erscheinungsdatum: 18.11.2008

Targeted Regulatory Writing Techniques: Clinical Documentation for Drugs and Biologics

Wood, Linda Fossati; Foote, MaryAnn

Basel ; Boston: Birkhäuser

Birkhäuser GmbH

Springer Basel

Germany, Germany

2009, PS, 2008

Basel, c2009

Includes bibliographical references and index.

"The secrets of regulatory writing for clinical documents in the drug and biologics industry in the 3 major regions of the world (Europe, Japan, and the United States) are revealed in this book. From organizing the writing process through securing the final signatures, the authors describe how to determine which document is needed (developing the target), how to start the process using writer's tools (templates and style guides), how to write individual documents (protocols, study reports, investigator's brochures, and integrated summaries, to name a few), and how to navigate review and sign-off. Details of writing each section of a document, and the relationship among documents is discussed, from the perspective of an efficient and timely writing process. Lessons learned are included in each chapter, describing real-life scenarios in the industry." "This book will be helpful for beginning medical writers, as well as writers with more experience who are interested in improving their skills. It is the first comprehensive book of regulatory writing for this industry, covers specific document types, as well as submissions to all major regions of the world, for drugs and biologics, and is written by 2 regulatory writers with more than 20 years experience each."--Jacket

The secrets of regulatory writing for clinical documents in the drug and biologics industry in Europe, Japan, and the United States are revealed in this book. From organizing the writing process through securing the final signatures, the authors describe how to determine which document is needed, how to start the process using writer's tools like templates and style guides, how to write individual documents, and how to navigate review and sign-off. Details of writing each section of a document and the relationship among documents are discussed. Lessons learned are included in each chapter, describing real-life scenarios in the industry. This book is helpful for beginning medical writers, as well as writers with more experience who are interested in improving their skills. It is the first comprehensive book of regulatory writing, covering specific document types, as well as submissions to all major regions of the world. It is written by two regulatory writers with more than 20 years experience each

<p>the Secrets Of Regulatory Writing For Clinical Documents In The Drug And Biologics Industry In The Three Major Regions Of The World (europe, Japan, And The United States) Are Revealed In This Book. From Organizing The Writing Process Through Securing The Final Signatures, The Authors Describe How To Determine Which Document Is Needed (developing The Target), How To Start The Process Using Writer's Tools (templates And Style Guides), How To Write Individual Documents (protocols, Study Reports, Investigator's Brochures, And Integrated Summaries, To Name A Few), And How To Navigate Review And Sign-off. Details Of Writing Each Section Of A Document, And The Relationship Among Documents Is Discussed, From The Perspective Of An Efficient And Timely Writing Process. Lessons Learned Are Included In Each Chapter, Describing Real-life Scenarios In The Industry.</p>

x, 237 p. : 24 cm
Includes bibliographical references and index

2023-06-28