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Omni Shoreham Hotel

Sep 12, 2016 7:00 AM - Sep 13, 2016 5:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Global Labeling 2016

Essential Updates on Worldwide Regulations and Guidelines

Session 7: Patient Labeling: Global View Part One

Session Chair(s)

Shinobu  Uzu, PhD

Shinobu Uzu, PhD

Senior Executive Director

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

This session provides updates on patient labeling in the EU, Canada, and Asia. EU Patient labeling initiatives will be discussed from the industry point of view, and Health Canada will discuss its ongoing initiative on Plain Language Labeling. In addition, the patient labeling landscape in Asia, including Japan, will be explained.

Speaker(s)

Megann  Looker

Patient Labeling Initiatives- EU

Megann Looker

Jazz Pharmaceuticals, United Kingdom

Executive Director, Head of Global Labeling

Michelle  Remillard

Canada's Patient Medication Information (Part III of the Product Monograph)

Michelle Remillard

Health Canada, Canada

Senior Policy Analyst, Pharmaceutical Drugs Directorate

Rie  Matsui, RPh

Patient Labeling in Japan and the Asian Market

Rie Matsui, RPh

Pfizer R&D Japan G.K., Japan

Senior Director, Regional Labeling Head for APAC, International Labeling

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