Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics - Softcover

Softcover

ISBN 10: 3764383615 ISBN 13: 9783764383619

Verlag: Birkhäuser Basel, 2010

Inhaltsangabe

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.

Über diesen Titel

Reseña del editor

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.

Details zur Ausgabe

• Verlag: Birkhäuser Basel
• Erscheinungsdatum: 2010
• Sprache: Englisch
• ISBN 10: 3764383615
• ISBN 13: 9783764383619
• Einband: Tapa blanda
• Auflage: 1
• Anzahl der Seiten: 252
• Herausgeber: Wood Linda Fossati
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: Nicht verfügbar