We strive to deliver the best value to our customers and ensure complete satisfaction for all our textbook rentals.
You can return your online books for any reason within our refund period – no questions asked.
Every order is available for express shipping, and return shipping is always free.
You'll be happy with the quality of your books (or we'll ship you another one on our dime).
You can extend your rental up to 14 days – at the same cheap daily rental rate.
If you decide to keep the book it will never cost more than the purchase price.
As always, you have access to over 5 million titles. Plus, you can choose from 5 rental periods, so you only pay for what you’ll use. And if you ever run into trouble, our top-notch U.S. based Customer Service team is ready to help by email, chat or phone.
Supplemental materials are not guaranteed for used textbooks or rentals (access codes, DVDs, workbooks).
Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
by:Linda Fossati Wood
At last! 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...
At last! 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. "Targeted Regulatory Writing Techniques" takes the reader from regulatory writing fundamentals, templates, and style guides through source documents (protocols and clinical study reports) to integrated documents (investigator's brochures, IMPD. ISS, ISE, and informed consents) to global submissions in Europe, Japan, and the United States. The comprehensive appendices provide examples of checklists, actual documents, and the submission forms required for Japan. An extensive glossary of terms is included. In summary, "Targeted Regulatory Writing Techniques: Clinical Documentation for Drugs and Biologics" offers a quick start up for the discipline, including regulatory context within which writing is performed.
Since launching the first textbook rental site in 2006, BookRenter has never wavered from our mission to make education more affordable for all students. Every day, we focus on delivering students the best prices, the most flexible options, and the best service on earth. On March 13, 2012 BookRenter.com, Inc. formally changed its name to Rafter, Inc. We are still the same company and the same people, only our corporate name has changed.