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Sheraton Pentagon City Hotel

2024 年 03 月 14 日 7:30 上午 - 2024 年 03 月 15 日 4:15 下午

900 South Orme Street, Arlington, VA 22204, USA

Global Labeling Conference

Join speakers from around the world sharing their labeling – Germany, Japan, Belgium, UK, Canada and more!

Session 3: eLabeling: Regulatory Environment, Early-stage Developments, and Global Adoption

Session Chair(s)

Mary Beth  Wilusz

Mary Beth Wilusz

Head, Regulatory Labeling Operations and Compliance

Daiichi Sankyo, Inc., United States

Rie  Matsui, RPh

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
  • Discuss the fit for purpose approach for e-labeling

Speaker(s)

Maslinda  binti Mahat, MSc, RPh

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

Elizabeth  Scanlan, PhD, MSc

EMA-HMA-EC ePI: Piloting and Beyond

Elizabeth Scanlan, PhD, MSc

European Medicines Agency, Netherlands

ePI Product Owner

Rie  Matsui, RPh

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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