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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

Chief Business Officer, Clinical Ink
Jonathan is responsible in helping sponsors and CROs better leverage eSource, eCOA and ePRO. At Clinical Ink, he is responsible for P&L across products and services and he is also focused on building partnerships with customers. Mr. Andrus joined Clinical Ink from BioClinica where... Read More →
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 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
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Advanced
  • Featured Topics Real World Evidence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session