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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 7 Track 2 - Touchdown! or Fumble? The Medical Writing-to-Publishing Handoff

Session Chair(s)

Stacy  Tegan

Stacy Tegan

Program Director

Transcelerate Biopharma, Inc., United States

Proper planning and communication between medical writing and publishing can facilitate a clean handoff and minimize threats to the submission timeline. The handoff from medical writing to the publishing team is critical and often occurs at the “11th hour” of the overall submission timelines. Often, medical writing deliverables are on the critical path and compete with publishing directives for the medical writers’ attention. This session will detail common risks, risk mitigation, and establishing integrated workflows across functions. Presenters provide perspectives of a project manager, medical writer, and finally the publisher to cover the end-to-end process of submission documents.


Natalie  Herr, PhD

Medical Writing Perspective

Natalie Herr, PhD

Whitsell Innovations, Inc., United States

Medical Writer, Consultant

Dove  Bunkin-Thomas, MS

Lead Writer Perspective

Dove Bunkin-Thomas, MS

Amgen, United States

Head of Vendor Oversight and Resource Management for Global Regulaotry Affairs

B.J.  Witkin

Publisher Perspective

B.J. Witkin

Impact Pharmaceutical Services, United States

Senior Manager, Regulatory Operations

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