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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, 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)
Shinobu Uzu, PHD
Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker
Francis Muigai Karanja, MSC, RPH
Regulatory Affairs Cluster Head, Africa, GlaxoSmithKline, Kenya
Labeling Challenges in Africa: An Industry Perspective
Chi-Sing Nip, PHARMD, MBA
Director, Global Labeling, Hoffmann-La Roche Limited, Canada
Labeling Challenges in Africa: An Industry Perspective
Meredith Yearsley Smith, MPA, FISPE
Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
What’s the Role of Patients in Patient Labeling?
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