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Session 4: End-to-End (E2) Labeling Process, Concepts, and Initiatives
Session Chair(s)
Gerrit Nijveldt, MS, MSc
Global Labeling Consultant
Opus Regulatory Inc., United States
Brandon Stempo
Practice Leader Regulatory Labeling
Opus Regulatory Inc, United States
Sylvie Pujol, MSc
Senior Director, Head of Global Labeling, Global Regulator Affairs
Ipsen, France
This session will cover a few important labeling end-to-end fundamental concepts. The start of the session will cover ownership, governance, and process alignment concepts to ensure quality deliverables related to labeling. Session 4 will also define the meaning of a company core position and what happens when there is a local deviation. It is important for an accurate understanding of what constitutes a deviation, with an assessment of the core position and subsequent tracking and documentation methodologies. The session will conclude with global compliance and PV readiness in relation to audits and inspections.
Learning Objective : - Demonstrate a clear understanding of labeling governance principles and their practical applications
- Explain the definition of a company core position and downstream process deliverables related to a local labeling deviation
- Identify the core fundamentals of audit and inspection criteria and organization readiness
Speaker(s)
Ownership, Governance, and Ownership
Megann Looker
Jazz Pharmaceuticals, United Kingdom
Executive Director, Head of Global Labeling
CCDS Deviations, Safety Signals, and Compliance
Yaroslav Ivanov, PharmD
Bristol Myers-Squibb, United States
Senior Director, Global Labeling Strategy
Labeling Audit Preparation and Readiness
Tara D Baer
Gilead Sciences, United States
Head of Labeling
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