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#249: Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
147AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-587-L04-P; CME 1.00; RN 1.00

This session will explore the ways in which the data quality criteria within the EMA, FDA and ICH M14 guidelines converge or diverge, and propose some definitive actions for consideration to achieve harmonization of terminology.

Learning Objectives

Examine the current fragmentation in RWD/RWE data quality standards and its impact on research and regulatory decisions; Identify the key stakeholders and their varying data quality criteria within the pharmaceutical landscape; Describe potential strategies for developing a unified data quality framework to enhance consistency and reliability in data-driven research.

Chair

Elena Popa, MPharm

Speaker

Panelist
Patrice Verpillat, DrMed, MD, PhD, MPH

Pursuing Opportunities for Harmonization in Using Real-World Data: ICH Update
Kelly Robinson, MSc

A Comparative Analysis of Data Quality Frameworks
Simon Bennett, MSc

Panelist
Rachele Hendricks-Sturrup, DrSc, MA, MSc


Speakers
PV

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency
He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →
avatar for Simon Bennett

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom
As Director of European Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities in key areas. Simon started at Biogen in 2003 in clinical development before moving into Regulatory Sciences... Read More →
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States
Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →
avatar for Elena Popa

Elena Popa

Chief of Staff, Global Regulatory Affairs, Bayer, Switzerland
Elena is a pharmacist by training with a master in drug safety & pharmacovigilance. She is the Chief of Staff for Global Regulatory Affairs at Bayer. Elena joined Bayer as a Regulatory Policy & Innovation Lead in 2022, a role which focused on the regulatory use and acceptance of RWD/RWE... Read More →
avatar for Kelly Robinson

Kelly Robinson

Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada
Kelly Robinson is the Director General of the Pharmaceutical Drugs Directorate at Health Canada. In this role she leads a multidisciplinary team responsible for the authorization of innovative and generic pharmaceuticals, clinical trial evaluation, and the Special Access Program... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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