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Walter E. Washington Convention Center

2015 年 06 月 14 日 2:30 下午 - 2015 年 06 月 18 日 6:45 下午

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

Tool Is a Good Four-Letter Word

Session Chair(s)

Nancy  Katz, PhD

Nancy Katz, PhD

President

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)

Ann  Rockley, MLIS

Structured Content Management: Today's Best Practice

Ann Rockley, MLIS

The Rockley Group Inc., Canada

Chief Executive Officer

Nancy  Katz, PhD

Text Analytics Software to Alleviate Writers Pain Points

Nancy Katz, PhD

Illyria Consulting Group, Inc., United States

President

Susan  Bairnsfather, MSc

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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