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DIA 2021 Global Annual Meeting
Driving Change Globally: Transforming the Regulators as Early Digital Adopters
Inka Heikkinen, MS, MSc
- Associate Director, Global Regulatory Policy
- MSD, 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.
European Commission Update
- Head of Unit B3
- European Commission, Belgium
DARWIN and the Steps Towards the Long Term Vision and EMA's Role in it
Peter Richard Arlett, MD, FFPM, FRCP
- Head Data Analytics and Methods Task Force
- European Medicines Agency, Netherlands
M. Khair ElZarrad, PhD, MPH
- Director (Acting) , Office of Medical Policy, CDER
- FDA, United States
Virginia Acha, PhD, MSc
- Global Lead, Global Regulatory Policy
- MSD, United Kingdom