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Virtual Event

Apr 20, 2020 7:45 AM - Apr 21, 2020 2:45 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Global Labeling Conference

Session 4: Emerging Labeling Markets/Growth Markets: What You Must Know to Manage Globally

Session Chair(s)

Theresa  Brunone, MLS, MS

Theresa Brunone, MLS, MS

Head-Labelling Compliance and Implementation, Global Labeling

GlaxoSmithKline, United States

Rie  Matsui, RPh

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)

Shinobu  Uzu, PhD

Speaker

Shinobu Uzu, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Senior Executive Director

Francis Muigai Karanja, MSc, RPh

Labeling Challenges in Africa: An Industry Perspective

Francis Muigai Karanja, MSc, RPh

GlaxoSmithKline, Kenya

Regulatory Affairs Cluster Head, Africa

Chi-Sing  Nip, PharmD, MBA

Labeling Challenges in Africa: An Industry Perspective

Chi-Sing Nip, PharmD, MBA

Hoffmann-La Roche Limited, Canada

Director, Global Labeling

Meredith  Smith, PhD, MPA, FISPE

What’s the Role of Patients in Patient Labeling?

Meredith Smith, PhD, MPA, FISPE

Evidera, Inc, United States

Senior Director, Implementation Science Pillar Lead

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