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Wednesday, June 26 • 4:15pm - 5:30pm
#382: Real World Data Quality for Regulatory Decision-Making

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-701-L04-P; CME 1.25; IACET 1.25; RN 1.25

Demonstrating the quality of real world data (RWD) to support regulatory decision-making is a topic of great interest. This session will explore what is being done to demonstrate that RWD is of sufficient quality to support regulatory assertions.

Learning Objectives

Describe how sponsors and data companies can demonstrate data quality, how FDA defines data quality, and how FDA reviewers assess real world evidence data quality; Discuss challenges with demonstrating data quality and what can be done to make advances in this area.


Rebecca Lipsitz, PhD


Evaluating Real World Data and Evidence
David Martin, MD, MPH

Considerations for Selecting an Appropriate Real World Data Source
Brande Yaist, MHS

Aspects of Data Relevancy and Quality for Regulatory-Grade Real World Data
David Thompson, PhD

Real World Evidence Regulatory Grade Quality: Lessons from Recent Use Cases
Rebecca A Miksad, MD, MPH

avatar for Rebecca Lipsitz

Rebecca Lipsitz

Associate Director, Janssen
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 David Martin

David Martin

Associate Director for Real World Evidence Analytics, OMP, CDER, FDA
David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions... Read More →
avatar for Rebecca Miksad

Rebecca Miksad

Senior Medical Director, Research Oncology, Flatiron Health
Rebecca Miksad is a health outcomes and clinical trial researcher who serves as senior medical director at Flatiron Health. In this role, Rebecca focuses on generating real-world evidence, establishing regulatory-grade quality and contributing to the development of clinically relevant... Read More →
avatar for David Thompson

David Thompson

Senior Vice President, Real World & Late Phase Research, Syneos Health
David Thompson, PhD is a health economist with 25+ years of experience in HEOR consulting and real-world research design. He currently holds the position of Senior Vice President for Real-World & Late Phase Research at Syneos Health, where he provides RWE design solutions to study... Read More →
avatar for Brande Yaist

Brande Yaist

Senior Director, Global Patient Outcomes & Real World Evidence, Eli Lilly and Company
Mrs. Yaist is the Senior Director of the Center of Expertise in Global Patient Outcomes and Real World Evidence at Eli Lilly and Company. She leads and develops the research talent and capabilities needed to provide scientific services/expertise and support across an array of core... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA