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ON DEMAND - Applying the Concepts of Good Clinical Practice in Real World Evidence
Session Chair(s)
Rebecca Lipsitz, PhD
Senior Director, TA Regulatory Intelligence and Portfolio Policy, Late R&I RA
AstraZeneca, United States
The purpose of this session is to hear different perspectives from industry and Health Authorities on how to ensure that real world evidence (RWE) studies are conducted in accordance with the principles laid out in Good Clinical Practice in order to support regulatory-decision making.
Learning Objective : Discuss the importance of GCP principles for conducting a study that meets quality metrics and standards; Describe why the activities and processes needed to demonstrate GCP may be different in real world evidence (RWE); Identify what a sponsor needs to do in a RWE study to demonstrate Good RWD/RWE Practice.
Speaker(s)
Bridging the Gap: High-Quality Real World Data
Richard Gliklich, MD
OM1, United States
Chief Executive Officer
Data Obtained from Sources Other Than Traditional Clinical Trails from GCP Perspective
Kassa Ayalew, MD, MPH
FDA, United States
Director, DCCE, OSI, Office of Compliance, CDER
Real World Data Perspectives Oncology Experience: Importance of Data Quality
Albert L Kraus, PhD
Pfizer Inc, United States
Senior Director, Global Regulatory Portfolio Lead Breast and Women's Cancers
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