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Thursday, June 18 • 8:00am - 9:00am
#402 L: FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-749-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will discuss FDA efforts to modernize clinical trials through real world evidence (RWE), decentralized clinical trials and the inclusion of digital health technologies. FDA experts will provide their perspectives on best practices for implementation.

Learning Objectives

Design modern clinical trials to collect real-world data in real-world evidence settings; Discuss key principles of decentralized clinical trials and key aspects for their implementation; Discuss how to plan for the inclusion of digital health technologies for remote data acquisition in modern clinical trials.

Chair

Elizabeth Kunkoski, MS

Speaker

Panelist
Leonard Sacks, MD

Panelist
Isaac R. Rodriguez-Chavez, MHS, PhD, MS


Speakers
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

Officer, Clinical Research Methodology, Reg Compliance & Medical Policy, CDER, FDA
Dr. Isaac R. Rodriguez-Chavez serves as a FDA, CDER Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development. He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology. Past positions in the last 20 years... 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 →

Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum