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Monday, June 28 • 1:00pm - 2:00pm
#119 SL: FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-530-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Elizabeth Kunkoski, MS


Leonard Sacks, MD

Heather Stone, MPH

Isaac R Rodriguez-Chavez, MHS, PhD, MS

avatar for Elizabeth Kunkoski

Elizabeth Kunkoski

Health Science Policy Analyst, OMP, CDER, FDA, United States
Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving digital health technologies and electronic records and storage in clinical investigations. She worked for 15 years in... Read More →
avatar for Isaac Rodriguez-Chavez

Isaac Rodriguez-Chavez

Senior Vice President, Scientific and Clinical Affairs, Head, Global COE, PRA Health Sciences, United States
Dr. Isaac R. Rodriguez-Chavez is a biomedical and regulatory leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, and Vaccinology. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical... Read More →
avatar for Leonard Sacks

Leonard Sacks

Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA, United States
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently... Read More →
avatar for Heather Stone

Heather Stone

Health Science Policy Analyst, Office of Medical Policy, CDER, FDA, United States
Ms. Stone received her undergraduate degree from Smith College and her masters in public health (epidemiology) from the University of Maryland's School of Public Health. Her research focus is on the creation of policies that will encourage drug development for infectious diseases... Read More →

Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum