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 a ~targeteda (TM) 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 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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