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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

  • Senior Program Manager
  • 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.

Speaker(s)

Natalie Herr, PhD

Medical Writing Perspective

Natalie Herr, PhD

  • Medical Writer, Consultant
  • Whitsell Innovations, Inc., United States
Dove Bunkin-Thomas, MS

Lead Writer Perspective

Dove Bunkin-Thomas, MS

  • Head of Vendor Oversight and Resource Management for Global Regulaotry Affairs
  • Amgen, United States
B.J. Witkin

Publisher Perspective

B.J. Witkin

  • Senior Manager, Regulatory Operations
  • Impact Pharmaceutical Services, United States

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