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Tuesday, June 25 • 4:15pm - 5:30pm
#293: Real World Evidence: How Does its Use Challenge Quality and Compliance Programs?

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-635-L04-P; CME 1.25; IACET 1.25; RN 1.25

Evaluation of real world evidence (RWD) in the context of regulatory decision making depends not only on the evaluation of the methodologies used to generate the evidence, but on the reliability and relevance of the underlying RWD. FDA uses on-site inspections and data audits to evaluate all aspects of the conduct and reporting of FDA regulated research including data derived in real world settings. Speakers will provide views from regulatory perspective.

Learning Objectives

Discuss the importance of reliable data derived from sources other than traditional clinical trials to support regulatory decision making; Identify factors that FDA considers for assessing the reliability of real world data through on site inspections.

Chair

Kassa Ayalew, MD, MPH

Speaker

CPRD Update
Susan Beatty, MSc

FDA Update
Ni Aye Khin, MD, MS

Industry Update
Jonathan Raymond Andrus, MS


Speakers
avatar for Jonathan Andrus

Jonathan Andrus

President and Chief Operating Officer, Clinical Research IO (CRIO), United States
Mr. Andrus brings over 25 years of executive management, operational, quality, and business experience to CRIO. Most recently he served as Chief Strategy Officer for Clinical Ink. Prior to that, he served as Senior Vice President for BioClinica (now Clario), where he led the e-clinical... Read More →
avatar for Kassa Ayalew

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Kassa Ayalew, M.D., M.P.H. is a Director of the Division 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 specialist with several years of clinical and... Read More →
avatar for Susan Beatty

Susan Beatty

Clinical Operations Manager, The Clinical Practice Research Datalink Group (CPRD); MHRA
Susan joined CPRD in 2017 as Clinical Operations Manager, responsible for the delivery of CPRD’s Interventional Research services. Previous to this role, Susan has over 18 years’ experience in clinical research, with senior positions at Oxford Biomedical Research Centre and Oxford... Read More →
NK

Ni Khin

Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDA
Dr. Ni Khin is currently Division Director in Division of Clinical Compliance Evaluation, Office of Scientific Investigations, CDER, FDA. In this position, she provides regulatory scientific oversight for CDER assigned bioresearch monitoring activities. She participates in onsite... Read More →

Tuesday June 25, 2019 4:15pm - 5:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Session
  • Level Advanced
  • Featured Topics Real World Evidence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session