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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, International Labeling
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)
Pharmacovigilance Risk Assessment
Victoria O'Keefe
Medicines and Healthcare Products Regulatory Agency, United Kingdom
Benefit Risk Scientific Assessor
EU Update- Regulations Perspective
Megann Looker
Jazz Pharmaceuticals, United Kingdom
Executive Director, Head of Global Labeling
Patient Labeling in Japan and Asia
Rie Matsui, RPh
Pfizer R&D Japan G.K., Japan
Senior Director, Regional Labeling Head for APAC, International Labeling
Japan Labeling Updates and Labeling Trends in Asia
Takashi Misu, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Coordinator