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Session 3: US Updates
Session Chair(s)
Paula Hudson, RPh, RAC
Director, Global Labeling
Eli Lilly and Company, United States
This session provides information on labeling-related regulatory guidances and current expectations that are essential for those involved in drafting and maintaining US labeling throughout its lifecycle.
Learning Objective :
At the conclusion of this session, participants should be able to:- Describe the latest information regarding SPL expectations and upcoming changes
- Identify best practices when developing patient labeling to prevent medication errors
- Gain industry insights from attending the FDA REdI Conference on Prescription Drug Labeling
- Understand the strengths and limitations for the Adverse Reaction section in US labeling
Speaker(s)
SPL Updates
Herbert L O'Brien
Bayer HealthCare Pharmaceuticals Inc., United States
Sr. Local Labeling Registration Manager
Insights and Learnings from the FDA REdI Conference
Gina Monteiro
Eli Lilly and Company, United States
Advisor
Adverse Reaction Section of the USPI
A. Leander Fontaine, MD
Pharmiceutics, LLC., United States
President
Adverse Reaction Section of the USPI
Barbara Lachmann, MD
Barbara Lachmann Labeling Consulting, Germany
Sole Proprietor