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This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice
Session Chair(s)
Andrew Emmett, MPH
Vice President, Global Regulatory Policy and Global Intelligence , Pfizer, United States
This panel will explore the blue skies of global regulatory pilot programs, including initiatives on real-world evidence (RWE), model-informed drug development (MIDD), innovative trials, and endpoints. Panelists will educate the audience on new opportunities and best practices for future pilot success.
Learning Objective : Critique new opportunities to participate in regulatory pilot programs at FDA and globally; Outline key lessons learned from pilot program case studies and experiences; Identify best practices to increase the likelihood of success for future pilot programs.
Speaker(s)
Danielle Friend Economo, PHD
Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson, United States
Moderator
Mary Jo Salerno, MPH, MS
Science Policy Analyst, ORDPURM, OND, CDER, FDA, United States
PDUFA VII Rare Disease Endpoint Advancement Program
Yueqin Zhao, PHD
Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States
Learnings from FDA PDUFA VII Advancing Real-World Evidence Program
Donna Boyce, MS, RAC
Senior Vice President & Head, Global Regulatory Sciences, Pfizer, United States
Industry Update
Rasika Kalamegham, PHD
Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
Industry Update
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