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Session 4: Value of Metrics and Human Performance in Labeling Development and Day 1 Closing Remarks
Session Chair(s)
Lauren Brunke, PharmD, RPh
Senior Director, Global Regulatory Affairs, Global Labeling
Eli Lilly and Company, United States
Theresa Brunone, MLS, MS
Head-Labelling Compliance and Implementation, Global Labeling
GlaxoSmithKline, United States
The Value of Metrics and Human Performance session will explore how different companies track compliance of labeling changes globally. This session will highlight examples of internal labeling governance groups that are being used to oversee and influence compliance of submission and implementation metrics on a global scale. The session will also include a presentation on a unique approach of applying human error analysis during labeling development and how setting people up for success can unlock opportunities to reduce the risk of human error.
Learning Objective : - Explain how labeling operations governance groups can be used to monitor submission and implementation metrics and oversee and influence labeling compliance
- Describe the opportunities and challenges of applying human error analysis techniques to labeling development
- Describe different ideas about how to set people up for success
Speaker(s)
Value of Metrics
Kelly Toetz
Eli Lilly and Company, United States
Consultant, Regulatory Process Owner
Value of Metrics and Human Performance in Labeling Development
Francesca Dickins
Eli Lilly and Company , United Kingdom
Lead Consultant (Regulatory)
Value of Metrics and Human Performance in Labeling Development
Julie Avery
Chatham Consulting LTD, United Kingdom
Company Secretary
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