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Driving Change Globally: Transforming the Regulators as Early Digital Adopters
Session Chair(s)
Inka Heikkinen, MBA, MSC
Regulatory Policy Lead
Lundbeck, Denmark
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 Objective : 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.
Speaker(s)
European Commission Update
Ioana-Maria Gligor
European Commission, Belgium
Head of Unit B3
DARWIN and the Steps Towards the Long Term Vision and EMA's Role in it
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
FDA Update
M. Khair ElZarrad, PHD, MPH
FDA, United States
Director, Office of Medical Policy, CDER
Industry Update
Virginia Acha, PHD, MSC
MSD, United States
Global Lead, Global Regulatory Policy