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Session 3 Track 2: From Guidance to Action: Strengthening Regulatory Writing in Oncology Trials
Session Chair(s)
Elizabeth Olbrich, MS, RN
Associate Director
PPD, United States
This session will help regulatory writers working with oncology trials with best practices for integrating the 2025 FDA guidance in oncology clinical trials into documents such as protocols, briefing packages, clinical study reports, and marketing expectations. The session will discuss how real-time reviews with FDA have been evolving over the past years and discuss examples of pathways and tools have been built to facilitate this real-time communication.
Learning Objective : - Identify key elements in the FDA Guidance in Oncology Clinical Trial Design on assessing overall survival in oncology clinical trials and the implications for clinical trial design
- Demonstrate how to align medical writing strategies to support successful regulatory submissions
- Describe regulatory pathways and tools driving real-time interactions
- Identify strategies for adapting communications to rapid regulatory feedback
Speaker(s)
Always On: Reshaping the Communication Chain Through Real-Time Reviews
Jason Casavant, JD
Synterex, Inc., United States
Executive Director, Medical Writing
Navigating New FDA Guidance in Oncology Clinical Trial Design: Considerations for Medical Writing
Andrea Clark, PhD
Eldridge Writing & Consulting LLC, United States
Principal Medical Writer
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