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Session 3 - Tracking from Signal to Package
Session Chair(s)
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
Baxter Healthcare Corporation, United States
Associate Director, Strategic Global Labeling
IT Perspective
Craig S. Trautman
Intagras, Inc., United States
CEO