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Session 3: Ensuring Excellence in Safety Labeling: Strategies, Collaboration, and Global Best Practices
Session Chair(s)
Kelly Treonze, MS
Head, Global Labeling Strategy
Merck & Co., Inc., United States
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
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Develop safety labeling text by applying insights and best practices shared during the case studies
Speaker(s)
Considerations in the Transfer from CCSI to CCDS Based Documentation
Vladimir Penkrat, MBA
Indegene, United States
Associate Vice President of Regulatory Affairs
Proactive Communication with Health Authorities for an Effective Labeling Change Process
Patricia Ann Fraser, MD, MPH, MS
PepGen, United States
Vice President, Head of Pharmacovigilance
Advancing Safety Label Change (SLC) Tracking
Jackie Mowry
Novartis, United States
Global Team Lead, Director, Labeling Compliance
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