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Bethesda North Marriott Hotel and Conference Center

Apr 09, 2014 7:00 AM - Apr 10, 2014 5:45 PM

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

Global Labeling 2014: Compliance in a Changing Regulatory Environment

Session 3 - Tracking from Signal to Package

Session Chair(s)

Julie P.  Retzinger, MBA, RN

Julie P. Retzinger, MBA, RN

Senior Director - Global Labeling and CCDS

Astellas Pharma Inc., United States

In this session we will examine the current regulatory environment regarding tracking of safety signals into prescribing information and then onto package. Additionally we will examine current IT tracking solutions, and how to implement globally.

Speaker(s)

Beth A. Lage, RAC

Beth A. Lage, RAC

Baxter Healthcare Corporation, United States

Associate Director, Strategic Global Labeling

Craig S. Trautman

IT Perspective

Craig S. Trautman

Intagras, Inc., United States

CEO

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