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Session 3: eLabeling: Regulatory Environment, Early-stage Developments, and Global Adoption
Session Chair(s)
Mary Beth Wilusz
Head, Regulatory Labeling Operations and Compliance
Daiichi Sankyo, Inc., United States
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC, International Labeling
Pfizer R&D Japan G.K., Japan
Various e-labeling initiatives are underway worldwide in the healthcare and pharmaceutical fields. This session will provide an overview of current developments in global e-labeling initiatives related to the electronic distribution of product prescribing and patient information, including: availability of labeling online (on a publicly accessible websites); use of machine-readable codes to provide access to user-friendly formats of labeling; and the elimination of paper labeling from commercial product packages. E-labeling should be structured content that utilizes the electronic common standard and eventually should be interoperable with the other healthcare system. The switch to e-labeling provides numerous benefits, including sustainability; however, it is not a simple change as it requires a change in regulations, processes, new ways of working across the organization, and new interactions with regulators. In this session, we will share lessons learned from markets who have made e-labeling happen and discuss best practices, including hearing the perspectives from the health authorities during review and implementation of e-labeling.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize global adoption trends of e-labeling initiatives
- Describe the best practices and challenges from e-labeling implementation
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Discuss the fit for purpose approach for e-labeling
Speaker(s)
e-Labelling Implementation in Malaysia: Journey and Experience
Maslinda binti Mahat, MSc, RPh
National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia, Malaysia
Head of Policy & Strategic Planning
EMA-HMA-EC ePI: Piloting and Beyond
Elizabeth Scanlan, PhD, MSc
European Medicines Agency, Netherlands
ePI Product Owner
Dynamic e-labeling Progress in Asia
Rie Matsui, RPh
Pfizer R&D Japan G.K., Japan
Senior Director, Regional Labeling Head for APAC, International Labeling
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