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Tuesday, June 29 • 3:00pm - 4:00pm
#250.1 RT L: Round Table Discussion: FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies

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Component Type: Forum
Level: Basic

Join us for a student-led round table discussion tied to session #119SL: FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies (Monday, June 28, 1:00PM - 2:00PM). Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message noting that the session has reached maximum capacity.

Chair

James Motyka

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 James Motyka

James Motyka

Student, University of Illinois At Chicago, United States
I am a fourth-year pharmacy student at UIC's College of Pharmacy. I have worked in several healthcare settings, including: pharma, health system, healthcare consulting, specialty pharmacy, and home clinical trial support. I am interested in leveraging digital health to solve complex... 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 →

Tuesday June 29, 2021 3:00pm - 4:00pm EDT
TBD Virtual Event Horsham, PA 19044
  16: Community Rounds, Forum |   09: Regulatory, Forum