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Session 4: End-to-End (E2) Labeling Process, Concepts, and Initiatives
Session Chair(s)
Halley A. Baker, RN
Practice Leader, Regulatory Labeling
Opus Regulatory, United States
Sylvie Pujol
Sr. 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.