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Tuesday, June 29 • 2:00pm - 3:15pm
#240 SL: Driving Change Globally: Transforming the Regulators as Early Digital Adopters

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-576-L04-P; CME 1.00; IACET 1.00; RN 1.00

The session revolves around the ambitious Agency work plan on big data. International regulator summit for data and real-world evidence (RWE) in the planning, we discuss the learnings on the advance analytic pilots, upskilling, secondary use a global data road maps.

Learning Objectives

Describe the work plans of regulators in different regions; Describe the current status of initiatives in EMA/HMA Big Data Steering Committee work plan; Discuss priorities and activities from different stakeholders.


Inka Heikkinen, MS, MSc


European Commission Update
Ioana-Maria Gligor

DARWIN and the Steps Towards the Long Term Vision and EMA's Role in it
Peter Richard Arlett, MD, FFPM, FRCP

FDA Update
M. Khair ElZarrad, PhD, MPH

Industry Update
Virginia Acha, PhD, MSc

avatar for Ioana-Maria Gligor

Ioana-Maria Gligor

Head of Unit B3, European Commission
Ioana Gligor is responsible for European Reference Networks and Digital Health, working previously on health issues in DG Employment, with a focus on the European Semester and European Social Fund. Prior to, she worked in the Secretariat General of the European Commission, in DG Employment... 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 Inka Heikkinen

Inka Heikkinen

Associate Director, Global Regulatory Policy, MSD, Denmark
avatar for Virginia Acha

Virginia Acha

Global Lead, Global Regulatory Policy, MSD, United Kingdom
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She recently joined MSD to lead regulatory policy efforts for innovation that will lead to better... Read More →
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Deputy Director, Office of Medical Policy, CDER, FDA, United States
Dr. ElZarrad is the Deputy Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads... Read More →

Tuesday June 29, 2021 2:00pm - 3:15pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session