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Tool Is a Good Four-Letter Word
Session Chair(s)
Nancy Katz, PhD
Illyria Consulting Group, Inc., United States
This symposium will describe software tools that facilitate the creation of regulatory documents included in an electronic common technical document (eCTD)-based drug application.
Learning Objective : Enumerate five features of at least three software programs that regulatory writers can use to write clinical documents included in an eCTD-based drug application (ie, marketing application); Describe three ways that these features might affect the timeliness, scientific accuracy, and reviewability of that application.
Speaker(s)
Structured Content Management: Today's Best Practice
Ann Rockley, MLIS
The Rockley Group Inc., Canada
Chief Executive Officer
Text Analytics Software to Alleviate Writers Pain Points
Nancy Katz, PhD
Illyria Consulting Group, Inc., United States
The Next Step in Good Regulatory Writer Practices (GRWP) Applies the Strategy of Topic Authoring and Content Management: Use this Tool to Save Time, Save Money, and Improve Quality
Susan Bairnsfather, MSc
EPharmaTech LLC, United States
CEO, Regulatory Writer, Regulatory Affairs Professional and Statistical Analyst
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