#272: This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice
Tuesday, June 18, 2024 3:15 PM to 4:15 PM · 1 hr. (US/Pacific)
Room 6F
09: Regulatory
Information
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.
CE
ACPECMERN
Session Level
Intermediate
Featured Topics
Real-World Data (RWD)- Real-World Evidence (RWE)
Speakers
MJS
Mary Jo Salerno
Science Policy Analyst, ORDPURM, OND, CDERFDARK
Rasika Kalamegham
Head, US Regulatory PolicyGenentech, A Member of the Roche Group
Danielle Friend Economo
Senior Director, US Head Regulatory Policy and IntelligenceJohnson & JohnsonDB
Donna Boyce
Senior Vice President & Head, Global Regulatory SciencesPfizer Inc
Andrew Emmett
VP, Global Regulatory Policy and Global IntelligencePfizerYZ
Yueqin Zhao
Lead Mathematical Statistician, OB, OTS, CDERFDA