Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

• Publisher:   Birkhäuser Basel
• Number Of Pages:   237
• Publication Date:   2008-12-05
• ISBN-10 / ASIN:   3764383615
• ISBN-13 / EAN:   9783764383619

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.

While ICH has told the global clinical development community what they want there has been confusion as to how to implement the guidelines. The confusion is particularly acute in the small biotech firms where MDs, PhDs and PharmDs are given the sole authority to write protocols, clinical study reports, integrated summaries of safety and efficacy without the oversight and SOPs that guide these steps in Big Pharma. Wood and Foote have created an outstanding book which should serve as a reference for clinical development professionals worldwide. Through clear narratives and templates they tell the reader how to create all the documents needed in a clinical development program even including this information for Japan which has long been a source of confusion even in Big Pharma.

This is a fine reference book. But, it is NOT well served by the Kindle. The tables are almost impossible to read, even with the zoom plus a magnifying glass. (The zoom hardly enlarges the tables and figures at all.) It is also the kind of book that you want to refer to "as needed" for certain types of documents. Navigating to the pages you want to refer to is extremely difficult. Get the paper version for this one!

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