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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, 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)
Megann Looker
Executive Director, Head of Global Labeling, Jazz Pharmaceuticals, United Kingdom
Ownership, Governance, and Ownership
Yaroslav Ivanov, PHARMD
Senior Director, Global Labeling Strategy, Bristol Myers-Squibb, United States
CCDS Deviations, Safety Signals, and Compliance
Tara D Baer
Head of Labeling, Gilead Sciences, United States
Labeling Audit Preparation and Readiness
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