DIA 2020 Global Annual Meeting

This event is now offered in a new entirely virtual format.

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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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