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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)
Deborah Bebbington
Head Global Labeling, Bayer Plc, United Kingdom
Introduction to the EMA Action Plan
Nisha Modha
Regulatory Labelling Site Head - Welwyn, Roche Products Limited , United Kingdom
Envisioning the Future of Labeling Through Digitization of Information and the Current Environment for eLabelling
Megann Looker
Executive Director, Head of Global Labeling, Jazz Pharmaceuticals, United Kingdom
The EC Report on the Shortcomings of the SmPC and PIL
Hayley Parker, PHD, MSC
Senior Vice President, Pepgen Inc., United States
Evaluation of the SmPC and the Impact to Regional Labels