Menu Back toDriving Change Globally: Transforming the Regulators as Early Digital Adopters

DIA 2021 Global Annual Meeting


Driving Change Globally: Transforming the Regulators as Early Digital Adopters

Session Chair(s)

Inka  Heikkinen, MS, MSc

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.

Speaker(s)

Ioana-Maria   Gligor

European Commission Update

Ioana-Maria Gligor

  • Head of Unit B3
  • European Commission, Belgium
Peter Richard Arlett, MD, FFPM, FRCP

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

FDA Update

M. Khair ElZarrad, PhD, MPH

  • Director (Acting) , Office of Medical Policy, CDER
  • FDA, United States
Virginia  Acha, PhD, MSc

Industry Update

Virginia Acha, PhD, MSc

  • Global Lead, Global Regulatory Policy
  • MSD, United Kingdom