Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

Linda Fossati Wood, MaryAnn Foote (Herausgeber)

Buch | Softcover

X, 238 Seiten

2008 | 2009
Springer Basel (Verlag)
978-3-7643-8361-9 (ISBN)

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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.

Regulatory writing fundamentals.- Developing a target.- Getting started.- Regulatory writing tips.- Templates and style guides: The nuts and bolts of regulatory documents.- Document review.- Source documents.- Protocols.- Clinical study reports.- Integrated documents.- Investigator's brochures.- Investigational medicinal products dossier.- Integrated summaries of safety and efficacy.- Informed consent forms.- Regulatory submissions.- Global submissions: The common technical document.- Clinical trial procedures and approval processes in Japan.- Region-specific submissions: United States of America.

Erscheint lt. Verlag	18.11.2008
Zusatzinfo	X, 238 p. 26 illus.
Verlagsort	Basel
Sprache	englisch
Maße	170 x 244 mm
Gewicht	423 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pharmazie ► PTA / PKA
	Technik ► Umwelttechnik / Biotechnologie
Schlagworte	Arzneimittel • clinical trial • Drugs • Hardcover, Softcover / Medizin/Pharmazie • HC/Medizin/Pharmazie • Safety • Style
ISBN-10	3-7643-8361-5 / 3764383615
ISBN-13	978-3-7643-8361-9 / 9783764383619
Zustand	Neuware