Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

By Linda Fossati Wood, MaryAnn Foote

• Paperback: 237 pages
• Publisher: Birkhäuser Basel; 1 edition,2008
• Language: English
• ISBN-10: 3764383615
• ISBN-13: 978-3764383619

Product Description:The book for anyone who writes regulatory documents or wishes to learn more about writing regulatory documents for the biopharmaceutical industry. "Targeted Regulatory Writing Techniques: Clinical Documentation for Drugs and Biologics", written by 2 well-known regulatory writers with a combined 40 years experience, provides detailed information on 'targeted' writing. Many books, papers, and Web sites provide information on what needs to be written and submitted to regulatory authorities, but this comprehensive book shows you how to approach the writing task in a logical process that permits rapid completion of writing.
"Targeted Regulatory Writing Techniques" is the first comprehensive book of regulatory writing for the biopharmaceutical industry, and covers specific documents types, as well as submission to all major regions of the world. The book provides a 'targeted' method of document development - a way of planning for information flow that maximizes efficiency and speed to submission. The book has a hands-on approach to identifying methods that quickly determine which document is required, how to write it, and how it fits into submission types. The authors share their experiences with numerous 'Lessons Learned' side bars of information.

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