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Bethesda North Marriott Hotel and Conference Center

24 abr 2018 7:00 a.m. - 25 abr 2018 3:00 p.m.

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

Global Labeling Conference

Session 3: US Updates

Session Chair(s)

Paula  Hudson, RPh, RAC

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

SPL Updates

Herbert L O'Brien

Bayer HealthCare Pharmaceuticals Inc., United States

Sr. Local Labeling Registration Manager

Gina  Monteiro

Insights and Learnings from the FDA REdI Conference

Gina Monteiro

Eli Lilly and Company, United States

Advisor

A. Leander  Fontaine, MD

Adverse Reaction Section of the USPI

A. Leander Fontaine, MD

Pharmiceutics, LLC., United States

President

Barbara  Lachmann, MD

Adverse Reaction Section of the USPI

Barbara Lachmann, MD

Barbara Lachmann Labeling Consulting, Germany

Sole Proprietor

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