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 a ~targeteda (TM) 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 a ~Lessons Learneda (TM) 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 (investigatora (TM)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, actualdocuments, 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.
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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 a ~targeteda (TM) 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 a ~Lessons Learneda (TM) 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 (investigatora (TM)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, actualdocuments, 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.
Imprint | Birkhauser Verlag AG |
Country of origin | Switzerland |
Release date | November 2008 |
Availability | Expected to ship within 10 - 15 working days |
First published | November 2008 |
Editors | Linda Fossati Wood, MaryAnn Foote |
Dimensions | 244 x 170 x 14mm (L x W x T) |
Format | Paperback |
Pages | 238 |
Edition | 2009 ed. |
ISBN-13 | 978-3-7643-8361-9 |
Barcode | 9783764383619 |
Categories | |
LSN | 3-7643-8361-5 |