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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)
Real-Time Oncology Review Program
Jennifer J. Lee, PharmD, RAC
FDA, United States
Senior Health Scientist, Oncology Center of Excellence
FDA Real Time Oncology Review: Planning Considerations from a Medical Writing Standpoint
Michael Gyulay
EMD Serono, United States
Director, Medical Writing, Oncology and I-Oncology
Industry RTOR Experience and Lessons Learned
Linda Bowen, MSc, RAC
Temple University Pharmacy School, United States
Assistant Adjunct Temple University
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