DIA 2021 Global Annual Meeting

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Driving Change Globally: Transforming the Regulators as Early Digital Adopters

Session Chair(s)

Inka Heikkinen, MBA, MS, MSc

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.

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

Merck Sharp & Dohme LLC, United Kingdom

AVP, Global Regulatory Policy

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