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Tuesday, June 27 • 4:00pm - 5:00pm
#276: Globally Accelerating the Drive to eLabeling for All

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-599-L04-P; CME 1.00; RN 1.00

The rapid increase in digitalization of our everyday life indicates that time is right for e-labeling. The many advantages that e-labeling offers support this but several technological and legislative hurdles remain. This session will discuss how these hurdles can be overcome by looking at best practices from around the globe.

Learning Objectives

Describe the current state of play regarding the technological development of ePI; Discuss future trends of required legislative readiness.

Chair

Koen Nauwelaerts, PharmD, PhD, MBA

Speaker

Electronic Labeling: How Have We Done and Where are We Going?
Rie Matsui, RPh

Value of eLabeling and the Current Situation in the EU
Koen Nauwelaerts, PharmD, PhD, MBA

IMI Gravitate Health
Catherine Chronaki, MSc, PMP

Patient Medication Information
Alexis Miller, JD


Speakers
avatar for Koen Nauwelaerts

Koen Nauwelaerts

Regulatory Policy and Innovation Lead, Bayer AG
Koen Nauwelaerts holds a Master’s degree in Pharmacy from Leuven University, Belgium and a PhD in Drug Development from the same university. Further he obtained an MBA degree from Vlerick Business School and completed the technology immersion program at MIT.Koen is currently working... Read More →
avatar for Rie Matsui

Rie Matsui

Senior Director, Regional Labeling Head for APAC, Pfizer Inc, Japan
Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates... Read More →
avatar for Alexis Miller

Alexis Miller

Acting Global Lead, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →
avatar for Catherine Chronaki

Catherine Chronaki

Secretary General, HL7 Europe Foundation, Belgium
A computer engineer by training with long experience in Health IT. As Secretary General of HL7 Europe, she is active in Digital Health Policy and Standards. She led Trillium Bridge and Trillium II projects on International Patient Summary standards under the EU-US MoU on eHealth... Read More →

Tuesday June 27, 2023 4:00pm - 5:00pm EDT
Room 156 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session |   09: Regulatory, Session