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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)
Ioana-Maria Gligor
Head of Unit B3, European Commission, Belgium
European Commission Update
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
DARWIN and the Steps Towards the Long Term Vision and EMA's Role in it
M. Khair ElZarrad, PHD, MPH
Vice President, Regulatory Policy, BridgeBio, United States
FDA Update
Virginia Acha, PHD, MSC
Global Lead, Global Regulatory Policy, Merck & Co., Inc., United States
Industry Update
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