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Session 5 Track 1: Labeling, Listing, and Compliance – Getting and Keeping Your Drug Product on the Market
Session Chair(s)
Kimberly Belsky, MS
Reg Policy & Intell and AdPromo, Regulatory Affairs
Independent, United States
Learning Objective : • Apply new FDA labeling guidances, Medication Error Initiatives, Safety Considerations for Packaging and Artwork design, and PLR Conversion Initiative in labeling and artwork development •Discuss how PLR in SPL format has facilitated various e-Labeling initiatives and how it is evolving.
Speaker(s)
Prescription Drug Labeling: Implementation of FDA’s New Guidances and Safety Initiatives in Label and Artwork Development
Christine Ferguson
Bayer HealthCare, United States
Global Labeling Manager-Global Labeling (US HUB), Global Regulatory Affairs,GROC
CDER Direct
Paul M. Loebach
FDA , United States
Team Leader, Drug Registration and Listing Program, OC, CDER
SPL Essentials to Bring Your Product to Patients
Mary Beth Wilusz
Daiichi Sankyo, Inc., United States
Head, Regulatory Labeling Operations and Compliance
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