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Session 7B1: Submission Survival Toolkit: Truth Versus Fiction
Session Chair(s)
Stephanie L. Byrdé, BSN, MS, RN
Advisor, Scientific Communications, Clinical Pharmacology
Eli Lilly & Company, United States
NDA and BLA submissions have a reputation for being scarier than the latest horror movie. Some of that reputation is well deserved, while some of it is urban legend. Hear from two uber-experienced submission writers who have been in the trenches of a submission and lived to tell about it. What’s their secret? Join them to find out how you, too, can survive a submission (mostly) intact!
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the knowns and unknowns of submission planning — when to plan and when to execute
- Articulate at least three ideas to consider incorporating into the plan for your next submission
- Recognize the value of mitigations and contingencies to avoid risk
Speaker(s)
Surviving the Storm: Planning for Submission Success
Deborah Frisby, MA
Eli Lilly and Company, United States
Scientific Communications Consultant
Speaker
Ann Winter-Vann, PhD
Whitsell Innovations, Inc., United States
Senior Writer and Manager
Panel Discussion
All Session Speakers, United States