10:00 AM - 10:30 AM
Summit Opening
10:30 AM - 11:45 AM
Keynote: ICH E6(R3) Guideline for Good Clinical Practice Update



M. Khair ElZarrad, PhD, MPH
ICH E6(R3) Rapporteur, FDA
Deputy Director, Office of Medical Policy
CDER, FDA

11:45 AM - 12:30 PM
Break
2:30 PM
Day 1 Closes