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Session 2: EU Labeling Updates
Session Chair(s)
Megann Looker
Executive Director, Head of Global Labeling
Jazz Pharmaceuticals, United Kingdom
This session will cover the latest developments in the eLabeling arena, as well as an overview of recent guidance updates and the latest thinking on regional labeling strategy.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the current environment for eLabeling
- Understand the EU timelines for MAAs and Linguistic Review in relation to other regional requirements and how these impact on other labels
Speaker(s)
Introduction to the EMA Action Plan
Deborah Bebbington
Bayer Plc, United Kingdom
Head Global Labeling
Envisioning the Future of Labeling Through Digitization of Information and the Current Environment for eLabelling
Nisha Modha
Roche Products Limited , United Kingdom
Regulatory Labelling Site Head - Welwyn
The EC Report on the Shortcomings of the SmPC and PIL
Megann Looker
Jazz Pharmaceuticals, United Kingdom
Executive Director, Head of Global Labeling
Evaluation of the SmPC and the Impact to Regional Labels
Hayley Parker, PhD, MSc
PepGen, United States
Vice President Regulatory Affairs