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Monday, June 15 • 11:00am - 12:00pm
#105 SL: To Shape the Future of Patient Labeling Across Regions

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-571-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session we will discuss ongoing initiatives in the field of electronic labeling and look ahead to their potential impact on the future of digital health, with a particular focus on patient product information in the US, EU, Japan, and Asia. This session will also discuss how different approaches to electronic labeling may converge across regions, driving a new patient-centric focus to product information.

Learning Objectives

Discuss how emerging trends for electronic labeling are impacting risk communication across the US, EU, Japan and Asia; Describe the challenges of provision of patient product information in the future; Discuss approaches to improving health literacy and adherence to patient labeling; Discuss the possibility of convergence of electronic labeling standards to drive patient centricity across regions.

Chair

Rie Matsui, RPh

Speaker

PMDA’s Updates for Electronic Labeling Initiative and Patient-Centric Labeling in Japan
Junko Sato, PhD

Electronic Product Information (ePI) in the EU: Key Principles and Beyond
Elizabeth Scanlan, PhD, MSc

Electronic Labeling in the US / Canada and A Global eLabeling Vision
Khyati Roberts, RPh

Dynamic Landscape in Asia for Electronic Labeling and Patient Labeling
Rie Matsui, RPh


Speakers
avatar for Junko Sato

Junko Sato

Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Office Director for the Office of International Programs. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 6 yrs. She... Read More →
avatar for Khyati Roberts

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, Inc.
Khyati leads regulatory policy advocacy efforts for the U.S. and Canada and coordiantes international harmonization efforts. She joined AbbVie in 2012 and has nearly 30 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on... Read More →
avatar for Rie Matsui

Rie Matsui

Senior Director, Regional Labeling Head for APAC, Pfizer R&D, Japan
Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group(ILG), Global Regulatory Affairs, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer.The Asia Labeling Hub has created various... Read More →
avatar for Elizabeth Scanlan

Elizabeth Scanlan

Scientific Communication Officer, Stakeholders and Communication Division, European Medicines Agency, Netherlands
Elizabeth Scanlan joined the European Medicines Agency in 2016 where she is a Scientific Communication Officer, with a focus on communication of information on safe and effective use of medicines to patients and healthcare professionals. Prior to joining EMA, she worked in communication... Read More →

Monday June 15, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   09: Regulatory, Session