戻る Agenda
FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies
Session Chair(s)
Elizabeth Kunkoski, MS
Health Science Policy Analyst, OMP, CDER
FDA, United States
This forum will discuss FDA efforts to modernize clinical trials using clinical practice data, decentralized clinical trials and the inclusion of digital health technologies. FDA experts will provide their perspectives regarding 21 CFR 11. Join us for a student-led follow up round table discussion (session #250.1 RT L) on Tuesday, June 29, 3:00PM - 4:00PM EDT.
Learning Objective : Design and conduct clinical trials using clinical practice data; Discuss the latest developments on decentralized clinical trials for their implementation; Identify how to plan for the inclusion of digital health technologies for remote data acquisition in clinical trials; Discuss how to consider the application of 21 CFR 11 in the conduct of modern clinical trials.
Speaker(s)
Panelist
Leonard Sacks, MD
FDA, United States
Director, Clinical Methodologies,Office of Medical Policy, CDER
Panelist
Heather Stone, MPH
FDA, United States
Health Science Policy Analyst, Office of Medical Policy, CDER
Panelist
Isaac R Rodriguez-Chavez, MHS, PhD, MS
4Biosolutions Consulting, United States