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Session 1: Digital Labeling and Panel Discussion
Session Chair(s)
Rie Matsui, RPH
Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan G.K., Japan
Deborah Bebbington
Head Global Labeling, Bayer Plc, United Kingdom
There are many on-going initiatives of digital labeling across regions such as European Union, Japan, Canada and Singapore, although paper labeling is still required in majority of countries. eLabeling will help to deliver the latest labeling information immediately in efficient and customer friendly way for patients safety. Also, eLabeling is driven by the acceleration of digital disruption and must consider patient-centricity. In this session, the current landscape of eLabeling initiatives for future digital health across regions will be shared and will be discussed from regulators’ and industry’s point of view.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand the updates on eLabeling landscape across regions
- Learn the company initiative on digital labeling
- Discuss digital labeling for future digital health
- Discuss the impact of eLabeling on company labeling process
Speaker(s)
Shinobu Uzu, PHD
Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker (Pre-recorded)
Craig Anderson
Director, Data Standards & Continuous Improvement, Pfizer, Canada
Update on Health Canada's XML Product Monograph Project
Aimad Torqui
Head of Division European cooperation and veterinary affairs , MEB, Netherlands
European Product Information – ePI Hot Air or Real Opportunities?
Nathalie Lambot, DRSC, MPHARM, RPH
Expert Santé Publique – Clinical Trials & Regulatory Affairs, pharma.be , Belgium
The Electronic Patient Leaflet Project (e-PIL) : A Pioneer Pilot in Belgium and Luxembourg
Mark Hendrickson, MS
Senior Director, Leavitt Partners, United States
Electronic Labeling: A U.S. Perspective
Rie Matsui, RPH
Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan G.K., Japan
Asia Updates for E-Labeling
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