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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)
Herbert L O'Brien
Sr. Local Labeling Registration Manager, Bayer HealthCare Pharmaceuticals Inc., United States
SPL Updates
Gina Monteiro
Senior Director, Global Regulatory Affairs – Global Core Labeling, Eli Lilly and Company, United States
Insights and Learnings from the FDA REdI Conference
A. Leander Fontaine, MD
President, Pharmiceutics, LLC., United States
Adverse Reaction Section of the USPI
Barbara Lachmann, MD
Sole Proprietor, Barbara Lachmann Labeling Consulting, Germany
Adverse Reaction Section of the USPI