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Thursday, July 1 • 11:30am - 12:30pm
#427 SL: Real-World Evidence: A Global Regulatory Perspective and Discussion

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-654-L04-P; CME 1.00; IACET 1.00; RN 1.00

The aim of this session is for senior regulators from both EMA and FDA to provide an overview of real- world evidence and data initiatives, standards and perspectives,. There will then be the opportunity for the audience to put questions to the presenters.

Learning Objectives

Discuss the global landscape for the use of real- world evidence and data; Describe some scenarios where such evidence may be put to use for regulatory decision-making; Engage in dialogue with senior regulators from FDA and EMA.


Andrew Thomson, PhD, MA, MS


Real-World Evidence at FDA
Robert Ball, MD, MPH, MSc

EU Update on Big Data and Real-World Evidence
Peter Richard Arlett, MD, FFPM, FRCP

Industry Update
Patrice Verpillat, DrMed, MD, PhD, MPH

avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics... Read More →
avatar for Peter Arlett

Peter Arlett

Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
Dr Peter Arlett - Head, Data Analytics and Methods Task Force, European Medicines Agency. Education: Medical Degree, University College London 1991; Member, Royal College of Physicians (MRCP) of London 1994; Fellow of the Faculty of Pharmaceutical Medicine (FFPM) of the Royal College... Read More →
avatar for Robert Ball

Robert Ball

Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug and biologic product safety and effectiveness using Real World... Read More →
avatar for Patrice Verpillat

Patrice Verpillat

Head of Global Epidemiology and ISPE RWE Task Force, Merck Healthcare KGaA, Germany
Dr Verpillat has started in the pharma industry in 2003 (H. Lundbeck A/S, Sanofi-Aventis Group, Boehringer Ingelheim GmbH, and currently at Merck KGaA/EMD Serono), in departments such as Epidemiology, Pharmacovigilance, Market Access, always dealing with real-world data and non-interventional... Read More →

Thursday July 1, 2021 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session