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!

Registration Ends

21

DAYS

21

HOURS

15

MINUTES

20

SECONDS

Session 3: Ensuring Excellence in Safety Labeling: Strategies, Collaboration, and Global Best Practices

Session Chair(s)

Kelly  Treonze, MS

Kelly Treonze, MS

Head, Global Labeling Strategy

Merck & Co., Inc., United States

Hayley  Parker, PhD, MSc

Hayley Parker, PhD, MSc

Senior Vice President

Pepgen Inc., United States

This session will focus on ensuring excellence in safety labeling, including strategies, collaboration and global best practices. Key topics include developing safety text for the CCDS, while balancing the need for to maintain global alignment with region-specific regulatory requirements and managing deviations. Emphasis will be placed on effective collaboration with cross-functional stakeholders (e.g., safety, commercial) through defined roles and responsibilities. The session will also feature case studies to showcase safety labeling practices across therapeutic areas and drug categories.

Learning Objective :
  • Integrate knowledge of regional guidelines on safety text in labeling to develop compliant and globally aligned safety text for the CCDS
  • Define the roles and responsibilities of various cross-functional stakeholders that participate in and/or implement safety labeling decisions
  • Develop safety labeling text by applying insights and best practices shared during the case studies

Speaker(s)

Patricia Ann Fraser, MD, MPH, MS

Speaker

Patricia Ann Fraser, MD, MPH, MS

PepGen, United States

Vice President, Head of Pharmacovigilance

Vladimir  Penkrat, MBA

Speaker

Vladimir Penkrat, MBA

Indegene, United States

Associate Vice President of Regulatory Affairs

Jackie  Mowry

Speaker

Jackie Mowry

Novartis, United States

Global Team Lead, Director, Labeling Compliance

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