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Wednesday, June 27 • 2:00pm - 3:15pm
#363: Innovative and Effective Authoring Strategies to Facilitate Accelerated Regulatory Submissions

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-660-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Kent Cochran, III, MS

Speaker

Forewarned is Forearmed: Lessons from a Survey on Tasks and Challenges Involved in Creating Module 2.7.3
Nancy Katz

Accelerated Submissions: Influencing Skills and Strategies for Medical Writers
Kent Cochran, III, MS

Clinical Core Dossier: A Sustainable Model to Expedite Market Expansion?
Michael Jasper


Speakers
KC

Kent Cochran

Director, Regulatory Medical Writing, Janssen Pharmaceutical Companies of Johnson & Johnson
A medical writer and manager for 20+ years, Kent has worked in multiple therapeutic areas (mainly Oncology) in small and large global companies, including Wyeth, Centocor, and Johnson & Johnson. His group supports clinical development projects in both early and late development. He... Read More →
MJ

Michael Jasper

Director, Medical Writing, Content Management, Shire
Michael received his BS in Electrical Engineering from Cornell University, an M.S. in Exercise Physiology and Anatomy from Boston University and his Ph.D. in Neurobiology, Physiology and Biophysics from Brown University, followed by a post-doctoral fellowship at Massachusetts General... Read More →
avatar for Nancy Katz

Nancy Katz

President and Principal, Medical Writing Consultant, Illyria Consulting Group, Inc.
Nancy is President of Illyria Consulting Group, Inc., which specializes in the creation of eCTD-compliant documents. As a DIA MW Community member, she chaired the E3 committee, which facilitated a Q & A to ICH E3, and the Education committee. She also serves on its extended core committee... Read More →

Wednesday June 27, 2018 2:00pm - 3:15pm
Room 157AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session