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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 10 Track 2: The Future is Here: Modern Medical Regulatory Documents Enabled by Structure, Standards, and Content Reuse

Session Chair(s)

Stacy  Tegan

Stacy Tegan

Program Director

Transcelerate Biopharma, Inc., United States

This session explores the emerging “new normal” of medical Regulatory documents through implementation of structured authoring to improve comprehension and reuse, application of technology to structured content for speed and quality, and a look at a modernized clinical study report.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Describe the benefits of applying structure to content, and why it enables content reuse
  • Discuss the impact on speed and quality when content reuse is enabled in medical regulatory documents
  • Compare and contrast traditional narrative driven clinical study reports which chronicled most activities and analyses conducted in a study vs. more modern ones that focus on objectives and results


Vyvyca  Walker, PhD, MS

Content is Still King: Benefits and Lessons Learned from Implementation of Structured Authoring in Clinical Development

Vyvyca Walker, PhD, MS

Eli Lilly and Company, United States

Scientific Communicatons Consultant

Mitzi  Allred, PhD

Living the Dream: Reusable Content in Action

Mitzi Allred, PhD

Merck & Co., Inc, United States

Director, Clinical Operations

Kelly  Lengyel, MS

CSR Now Stands for “Concise Study Reports” - Less Really Is More

Kelly Lengyel, MS

Allergan, United States

Director, Global Medical Writing, Regulatory Affairs

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