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Session 5: Global Labeling Issues and Updates: EU and Asia
Session Chair(s)
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan G.K., Japan
The regulatory perspective on key labeling-related developments in the EU will be addressed in this session as will the relationship of the pharmacovigilance risk assessment to labeling updates. Representatives of the PMDA will discuss the latest labeling updates from Japan, and labeling trends in the broader Asia region will be examined from the industry perspective.
Speaker(s)
Victoria O'Keefe
Benefit Risk Scientific Assessor, Medicines and Healthcare Products Regulatory Agency, United Kingdom
Pharmacovigilance Risk Assessment
Megann Looker
Executive Director, Head of Global Labeling, Jazz Pharmaceuticals, United Kingdom
EU Update- Regulations Perspective
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan G.K., Japan
Patient Labeling in Japan and Asia
Takashi Misu, PhD
Principal Coordinator, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Japan Labeling Updates and Labeling Trends in Asia
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