Books and Published Works
Writing for the Biopharmaceutical Regulatory Reader just published!
|
|
This book provides guidance for beginning and advanced authors, as well as reviewers, of biopharmaceutical documentation.
Written by Greg Cuppan and Stephen Bernhardt, the book is intended for those who wish to improve their ability to contribute to high-quality regulatory writing. Whether it is a briefing book, responses to regulatory inquiries, or marketing authorization packages, this book will help you think more productively about regulatory readers, how they use what you have written, and how to accomplish more within a paragraph, section, an entire document, or a complex dossier. Over the past 30 years, we have had the opportunity to formally evaluate how readers engage with submission documents. These interactions have helped us to refine our understanding of the decision-making behavior of the regulatory reader. In this book, we explore the kinds of questions many writers face on a routine basis:
|
Learn More:
|
Why did we create the book?
"The fact is that people in industrial settings often don't get help with their writing...There's a gap between a college classroom and a work setting." |
Document Design
"Information design is essential to the success of all regulatory writing projects...We have to create a document the reader can use." |
|
What makes regulatory writing different from other scientific writing?
|
What makes this book different?
|
Coming Soon:
A paperback version of Writing for the Biopharmaceutical Regulatory Reader is in the works.
Greg and Stephen are also working on a book for chemists, specifically those who work to assure quality in CMC (chemistry, manufacturing, control).
Greg and Stephen are also working on a book for chemists, specifically those who work to assure quality in CMC (chemistry, manufacturing, control).
