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Topics Related to the Oncology Real-Time Oncology Review Process
Session Chair(s)
Britta Jacobsen, PHD
Medical Writer and Consultant, Whitsell Innovations, Inc. , United States
This session focuses on the oncology real-time oncology review (RTOR) process and the considerations compared to a standard oncology submission, medical writing processes, and potential time savings.
Learning Objective : Describe the Real-Time Oncology Review (RTOR) program and processes; Describe industry's experience with RTOR; Understand how RTOR can impact global submission planning.
Speaker(s)
Jennifer J. Lee, PHARMD, RAC
Senior Health Scientist, Oncology Center of Excellence, FDA, United States
Real-Time Oncology Review Program
Michael Gyulay
Director, Medical Writing, Oncology and I-Oncology, EMD Serono, United States
FDA Real Time Oncology Review: Planning Considerations from a Medical Writing Standpoint
Linda Bowen, MSC, RAC
Adjunct Professor, Temple University Pharmacy School, United States
Industry RTOR Experience and Lessons Learned
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