Targeted regulatory writing techniques : clinical documents for drugs and biologics / edited by Linda Fossati Wood and MaryAnn Foote.

Format:

Book

Contributor:

Wood, Linda Fossati.

Foote, MaryAnn.

Language:

English

Subjects (All):

Medical writing.

Physical Description:

x, 237 pages : illustrations ; 24 cm

Place of Publication:

Basel ; Boston : Birkhäuser, [2009]

Summary:

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.

This book serves as a valuable source of information 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 two regulatory writers with more than 20 years experience each. Value-added features include extensive appendices of sample documents and a comprehensive glossary of terms.

Contents:

Regulatory writing fundamentals

Chapter 1 Developing a target / Linda Fossati Wood 3

Chapter 2 Regulatory writing tips / Linda Fossati Wood 27

Chapter 3 Templates and style guides: The nuts and bolts of regulatory documents / James Yuen, Debra L Rood 33

Chapter 4 Document review / Linda Fossati Wood, Mary Ann Foote 45

Source documents

Chapter 5 Protocols / Linda Fossati Wood 53

Chapter 6 Clinical study reports / Linda Fossati Wood 69

Integrated documents

Chapter 7 Investigator's brochures / Linda Fossati Wood 105

Chapter 8 Investigational medicinal products dossier / Linda Fossati Wood 121

Chapter 9 Integrated summaries of safety and efficacy / Jennifer A Fissekis 125

Chapter 10 Informed consent forms / Jennifer A Fissekis 131

Regulatory submissions

Chapter 11 Global submissions: The common technical document / Peggy Boe 141

Chapter 12 Clinical trial procedures and approval processes in Japan / Takumi Ishida, Katsunori Kurusu 155

Chapter 13 Region-specific submissions: United States of America / Linda Fossati Wood 173

I Regulatory review checklists 189

II Sample clinical protocol outline 193

III Sample clinical protocol title page 195

IV Sample clinical protocol signature page 196

V Sample clinical protocol synopsis 197

VI Sample list of abbreviations 198

VII Sample protocol amendment 199

VIII Sample clinical study report title page 202

IX Sample clinical study report synopsis 203

X Clinical study report outline: ICH E3 and suggested versions 208

XI Sample investigator's brochure outline 213

XII Investigational medicinal products dossier previous human experience outline 214

XIII Sample informed consent form 216

XIV Japanese regulatory forms 218.

Notes:

Includes bibliographical references and index.

ISBN:

3764383615

9783764383619

OCLC:

233552405