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Session 4: Emerging Labeling Markets/Growth Markets: What You Must Know to Manage Globally
Session Chair(s)
Theresa Brunone, MLS, MS
Head-Labelling Compliance and Implementation, Global Labeling
GlaxoSmithKline, United States
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC, International Labeling
Pfizer R&D Japan G.K., Japan
This session will focus on labeling concepts such as the reference label, patient labeling, and beyond the label information, and how they are addressed across the world. In emerging markets, seeking clarity on what is required for each of these related elements can reduce the challenges of managing affiliates. The session will explore this and other labeling concepts you must know to successfully manage labeling in global markets.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify markets where Reference Market/Reference Labeling is legally required and those where is it common practice
- Discuss what documents are commonly required by dependent markets from Reference Markets
- Describe which markets require availability of information in patient-friendly language
Speaker(s)
Speaker
Shinobu Uzu, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Executive Director
Labeling Challenges in Africa: An Industry Perspective
Francis Muigai Karanja, MSc, RPh
GlaxoSmithKline, Kenya
Regulatory Affairs Cluster Head, Africa
Labeling Challenges in Africa: An Industry Perspective
Chi-Sing Nip, PharmD, MBA
Hoffmann-La Roche Limited, Canada
Director, Global Labeling
What’s the Role of Patients in Patient Labeling?
Meredith Smith, PhD, MPA, FISPE
Evidera, Inc, United States
Senior Director, Implementation Science Pillar Lead