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Thursday, June 18 • 5:00pm - 6:00pm
#519 OD: ON DEMAND - Applying the Concepts of Good Clinical Practice in Real World Evidence

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Component Type: Session
Level: Intermediate

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 Objectives

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.

Chair

Rebecca Lipsitz, PhD

Speaker

Bridging the Gap: High-Quality Real World Data
Richard Gliklich, DrMed, MD

Data Obtained from Sources Other Than Traditional Clinical Trails from GCP Perspective
Kassa Ayalew, MD, MPH

Real World Data Perspectives Oncology Experience: Importance of Data Quality
Albert L Kraus, PhD



Speakers
avatar for Kassa Ayalew

Kassa Ayalew

Branch Chief, Office of Scientific Investigations, Office of Compliance, CDER, FDA
Kassa Ayalew, M.D., M.P.H. is a Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease... Read More →
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, OM1, United States
Dr. Richard Gliklich is the CEO of OM1, Inc., a real-world data, outcomes and technology company focused on using data and AI to accelerate medical research and personalize medicine, especially in chronic conditions. OM1 develops extensive data networks of participating practices... Read More →
avatar for Rebecca Lipsitz

Rebecca Lipsitz

Director, Regulatory Policy, Janssen, United States
Rebecca Lipsitz is a Director in Janssen’s Global Regulatory Policy and Intelligence office. She advises and develops policy on a broad range of FDA-related regulatory issues. Her portfolio areas include Immunology, Infectious Disease, Vaccines, Precision Medicine, Combination Products... Read More →
avatar for Albert Kraus

Albert Kraus

Senior Director, Global Regulatory Portfolio Lead Breast and Women's Cancers, Pfizer Inc


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session