Loading…
Back To Schedule
Wednesday, June 28 • 8:30am - 9:30am
#305: Real-World Data Quality: Components and Considerations of Data Sources Used for Regulatory Decision-Making

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Tweet Share
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-608-L04-P; CME 1.00; RN 1.00

This panel discussion will explore common questions related to the assessment of real-world data (RWD) quality. The panel will include representatives from the pharma industry, regulatory authorities and data service providers all of whom are instrumental in driving today's discussion on data relevance and reliability in the context of the use of that data for regulatory decision-making. The session will be interactive and include audience polling. Questions from the audience will be welcomed.

Learning Objectives

Describe the expectations for supportive evidence of quality in the use of real-world evidence/real-world data (RWE/RWD) in regulatory decision-making; Discuss the extent to which processes used to generate RWE/RWD should be documented when used in the context of a regulatory submission.

Chair

Abi Seifert, MBA

Speaker

Panelist
Andre Araujo, PhD

Panelist
Catherine Cohet, PhD

Panelist
Adam Aten, MPH, MSc

Panelist
Nicholaas Honig, JD


Speakers
avatar for Andre Araujo

Andre Araujo

Head of Real-World Analytics (RWA), GlaxoSmithKline, United States
Andre B. Araujo, PhD is an epidemiologist and is the Head of Real-World Analytics (RWA) at GSK. The RWA team is composed of analysts and data scientists who provide design and analytics to support the generation of high-quality real-world evidence in support of the GSK portfolio... Read More →
avatar for Adam Aten

Adam Aten

Legislative and Regulatory Policy Lead, Verily, United States
Adam Aten is the Legislative and Regulatory Policy Lead at Verily Life Sciences within the Government Relations and Public Affairs team. In this role, he coordinates the development and execution of Verily's federal legislative and regulatory strategy. Previously, he was an Assistant... Read More →
avatar for Catherine Cohet

Catherine Cohet

Pharmacoepidemiology Sr Spec, RWE Workstream, Data Analytics Methods Task Force, European Medicines Agency, Netherlands
Catherine is a senior pharmacoepidemiologist in the Real-World Evidence Workstream, Data Analytics & Methods Task Force of the European Medicines Agency. She previously held various industry positions, generating and evaluating RWE across all phases of development. She also worked... Read More →
avatar for Nicholaas Honig

Nicholaas Honig

Senior Regulatory Counsel, Aetion; Representing, RWE Alliance, United States
Nicholaas Honig is a Senior Regulatory Counsel at Aetion. In this role he advises clients on regulatory approaches involving Real-World Evidence and analyzes FDA approval decisions to understand RWE precedent. Prior to joining Aetion, Nicholaas worked at Pfizer in the company's Chief... Read More →
avatar for Abi Seifert

Abi Seifert

Global Head Country Development Quality, Novartis , United States
Abi has worked in the Pharma industry for over 25 years, serving in clinical development in both QA and operational roles. Her career started in clinical study monitoring and GCP auditing and evolved into roles that defined strategy around project management, process excellence and... Read More →

Wednesday June 28, 2023 8:30am - 9:30am EDT
Room 253 A Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech, Forum