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Bethesda North Marriott Hotel and Conference Center

Apr 24, 2018 7:00 AM - Apr 25, 2018 3:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Labeling Conference

Session 2: EU Labeling Updates

Session Chair(s)

Megann  Looker

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

Introduction to the EMA Action Plan

Deborah Bebbington

Bayer Plc, United Kingdom

Head Global Labeling

Nisha  Modha

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

Megann  Looker

The EC Report on the Shortcomings of the SmPC and PIL

Megann Looker

Jazz Pharmaceuticals, United Kingdom

Executive Director, Head of Global Labeling

Hayley  Parker, PhD, MSc

Evaluation of the SmPC and the Impact to Regional Labels

Hayley Parker, PhD, MSc

Pepgen Inc., United States

Senior Vice President

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