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Wednesday, June 28 • 4:00pm - 5:00pm
Quality by Design for Real-World Evidence Studies

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Component Type: Forum
Level: Intermediate

This session will engage an expert panel in a discussion on a number of data-quality focused areas of real-world evidence (RWE) studies. Data providers, curators, sponsors, policy organizations, and regulators will discuss and align on different tool.

Learning Objectives

Describe inherent challenges to data quality in real-world evidence studies; Evaluate implications of recent regulatory agency guidelines on real- world data quality; Describe quality-focused solutions to improve the quality of real-world evidence studies.

Chair

Chelsea O'Connell, MSc

Speaker

Assessing the Reliability of Real-World Data and Real-World Data Sources: A Sponsor Problem?
Jason Wakelin-Smith


Speakers
avatar for Chelsea O'Connell

Chelsea O'Connell

Director, Global Regulatory and R&D Policy, Amgen, United States
Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across various... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Wednesday June 28, 2023 4:00pm - 5:00pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: RD Quality-Compliance, Forum