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The Westin Arlington

2025年4月07日 (月) 午前 7:00 - 2025年4月08日 (火) 午後 4:00

801 N. Glebe Road, Arlington, VA 22203, USA

Global Labeling Conference

Join speakers from around the world sharing their labeling expertise!

Early Bird Rates Expire

DAYS

HOURS

MINUTES

SECONDS

Session 4: End-to-End (E2) Labeling Process, Concepts, and Initiatives

Session Chair(s)

Halley A. Baker, RN

Halley A. Baker, RN

Practice Leader, Regulatory Labeling

Opus Regulatory, United States

Sylvie  Pujol

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.

Learning Objective :
  • Demonstrate a clear understanding of labeling governance principles and their practical applications
  • Understand 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

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