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Innovative and Effective Authoring Strategies to Facilitate Accelerated Regulatory Submissions
Session Chair(s)
Kent Cochran, MS
Executive Director, GDDC Group, LLC, United States
Medical writers are under increased pressure to produce submission documents within very short timelines. Complications include too many reviewers, senior management reviews coming in late in the process, and multiple additional analyses resulting in new tables and figures. This session will highlight strategies that are within the sphere of influence of the medical writer.
Learning Objective : Identify how to apply influencing skills and strategies that a medical writer can use to prevent issues that derail efficient submission document production; Describe areas the medical writer can positively influence during submission planning.
Speaker(s)
Nancy Katz, PHD
President, Illyria Consulting Group, Inc., United States
Kent Cochran, MS
Executive Director, GDDC Group, LLC, United States
Michael Jasper
Content Management Team Lead, Medical Writing, , Takeda, United States
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