EAN: 9783764383619

TARGETED REGULATORY WRITING TECHNIQUES CLINICAL...

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.

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