Global Electronic Labeling Initiatives: Updates from Japan, Canada, Europe, US & Asia

Published Date: Jul 01, 2020

Digital format can improve readability of product information especially in context of structured data

Author(s)

Rie Matsui

Senior Director, Regional Labeling Head for APAC, International Labeling

Pfizer R&D Japan G.K.

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 for more than 25 countries in Asia. She was a member of the Advisory Council of DIA Japan until 2020 and received the DIA Japan regional award in 2015. Her papers were published in scientific journals such as Therapeutic Innovation & Regulatory Science. She is the vice chair of the 2021 DIA Japan Annual Meeting Program Committee. She received DIA Global Inspire Award Connector in 2022. She is teaching at Keio University and Chiba University and is a pharmacist.

Mrs. Deborah Bebbington

Vice President, Head Labeling

Bayer Plc

Deborah has been working in the Pharmaceutical Industry for over 25 years. She began her career in Research before moving into Regulatory Affairs. During her tenure at Bayer Deborah worked in the UK affiliate, as an EU liaison, set up a new global RA department focussing on the RA support for Mature products and headed the International RA department before moving to her current position 6 years ago. She is currently VP and Head of Global Labeling at Bayer.

Mr. Shinobu Uzu

Senior Executive Director

Pharmaceuticals and Medical Devices Agency (PMDA)

Mr. Shinobu Uzu is senior Executive Director, PMDA since April 2020. As Chief Safety Officer, PMDA, he was responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law until March 2018. Mr. Uzu took Master degree of Pharmacy from graduate school of the University of Tokyo. He has over twenty years’ experience in Ministry of Health, Labour and Welfare and dealt with pharmaceutical and food safety affairs including international pharmaceutical affairs and food standard issues.

Craig Anderson

Sr Expert, Program Development

Health Canada

Craig Anderson is a Senior Expert, Program Development in the Transformation and Business Informatics Division at Health Canada. Craig is responsible for leading regulatory informatics projects like the implementation of the Structured Product Labeling (SPL) standard; development of health informatics policy and IT modernization.

Mr. Aimad Torqui

Director Global Regulatory Policy

MSD, the Netherlands

Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment includes Medicines Evaluation Board and Novartis Vaccines. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.

Ms. Nathalie Lambot

Expert Santé Publique – Clinical Trials & Regulatory Affairs

pharma.be

Nathalie Lambot (Expert Public Health – Clinical trials & Regulatory Affairs at pharma.be) Nathalie Lambot has been graduated as pharmacist in from the Free University of Brussels, Belgium, and has had a PhD in Biomedical Sciences from the Free University of Brussels, Belgium. After having worked several years in CRO and pharmaceutical company in international regulatory affairs, Nathalie Lambot has joined in January 2013 pharma.be, the Belgian association of innovative (bio) pharmaceutical industry, as expert in Public Health – Clinical Trials & Regulatory Affairs.

Mr. Mark Hendrickson

Senior Director

Leavitt Partners

Mark is a Senior Director at Leavitt Partners based in Washington, D.C. He advises health care coalitions and provides policy counsel and analysis involving regulation and legislation. Prior to joining Leavitt Partners, Mark was the Senior Director of Sciences and Regulatory Affairs at the Association for Accessible Medicines (AAM). He was also an industry negotiator for multiple user fee agreements between FDA and industry and managed several industry working groups focused on pharmaceutical supply chain security and DSCSA implementation. Mark received his B.A. from Miami University and his M.S. in Regulatory Science from the University of Maryland.