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Session 10 Track 2: The Future is Here: Modern Medical Regulatory Documents Enabled by Structure, Standards, and Content Reuse
Session Chair(s)
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
Speaker(s)
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
Living the Dream: Reusable Content in Action
Mitzi Allred, PhD
Merck & Co., Inc, United States
Director, Clinical Operations
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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