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Welcoming Remarks and Session 1: Current and Future Labeling Landscape
Session Chair(s)
Deborah Bebbington
Head Global Labeling
Bayer Plc, United Kingdom
Hayley Parker, PhD, MSc
Vice President Regulatory Affairs
PepGen, United States
The session will provide a foundational overview of the key labeling requirements in major markets. It will highlight some of the more recent and upcoming regulations that influence labeling decision making. It will touch upon some of the most common challenges encountered when managing labeling on a global level. It will also discuss some of the implications and considerations for personalized medicines in comparison to traditional medicines.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify the key labeling requirements in major markets
- Describe the implications of recent regulations on labeling texts in major markets
- Recognize the evolving landscape of labeling in the future world of personalized medicine
Speaker(s)
Key Labeling Regulations in Europe
Misti Link, PMP
Vertex Pharmaceuticals, United States
Regulatory Labeling Director
Current Japanese Regulation and Future Developments
Tomoko Ohsawa, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director of Office of Informatics and Management for Safety
FDA Labeling Resources Top Hits
Audrey Anderson, MS
Bayer, United States
Executive Director - Head - Global Content 2 & US Labeling Strategy, Pharmaceuti
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