Targeted Regulatory Writing Techniques—Clinical Documents for Drugs and Biologics

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.