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Innovative and Effective Authoring Strategies to Facilitate Accelerated Regulatory Submissions
Session Chair(s)
Kent Cochran, MS
Executive Director
Eisai Co., Ltd., 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)
Forewarned is Forearmed: Lessons from a Survey on Tasks and Challenges Involved in Creating Module 2.7.3
Nancy Katz, PhD
Illyria Consulting Group, Inc., United States
Accelerated Submissions: Influencing Skills and Strategies for Medical Writers
Kent Cochran, MS
Eisai Co., Ltd., United States
Executive Director
Clinical Core Dossier: A Sustainable Model to Expedite Market Expansion?
Michael Jasper
Takeda, United States
Content Management Team Lead, Medical Writing,
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