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.

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 focusing on the RA support for Mature products and headed the International RA department before moving to her current position 12 years ago. She is currently VP and Head of Global Labeling at Bayer.

Beginning her career at Cambridge University, Hayley began working in clinical research. Moving to GSK, continuing a career in clinical trials (HIV, respiratory viruses), Hayley began a part-time PhD and eventually transferred to Regulatory. Hayley joined the ALP team at Biogen Idec (UK) and then moved to the USA to lead Global Labeling. In 2016 Hayley joined Vertex Pharmaceuticals Inc., to lead and develop the Global Labeling function. Subsequently, Hayley joined Scholar Rock as VP of Regulatory Affairs as a therapeutic lead. Then she moved to her current position as VP Head of Regulatory Affairs and Medical Writing at PepGen Inc. a company developing treatments for rare neuromuscular diseases.

Kelly M.Treonze, MS Director, Worldwide Product Labeling, Merck & Co., Inc. Kelly leads a team of 9 direct reports with responsibility for global labeling operations and strategy supporting Merck’s oncology and vaccine products. In addition, Kelly is responsible for establishing and refining processes and strategies with the overall goal of develop high quality labeling. Kelly joined Merck in 2000 and has also held positions in Immunology, Basic Research. Kelly received her M.S. in Molecular Biology from Lehigh University and her B.S. in Biology from Boston College.

Gina Monteiro has 6 years of labeling management experience with Eli Lilly’s Global Regulatory Labeling organization and currently in the Drug Delivery and Digital Health Global Regulatory Department. She has overseen the development of Core Data Sheets, US and Canadian labeling for Lilly’s Bio-Medicines, Oncology, Diabetes, Medical Device and Digital Health product portfolios. Prior to joining the global labeling organization, Gina held a number of previous positions at Eli Lilly including US Medical, Pharmacovigilance and US Regulatory, Advertising and Promotion Quality. Gina worked as a Clinical Research Associate (CRA) prior to joining Eli Lilly in 2001. Gina obtained her B.A. from The University of Michigan.

Mary Beth is Head of Regulatory Labeling Operations and Compliance at Daiichi Sankyo, Inc. where she leads a team responsible for optimizing processes, implementing innovative technologies, monitoring compliance, developing packaging, and ensuring labeling quality for oncology and specialty medicine products. She has >30 years’ experience in the pharma/bio industry at large & small companies, with >20 years in labeling. She previously led labeling strategy, operations, and compliance teams at Shire/Takeda and Merck & Co., Inc. Mary Beth is passionate about developing her team, collaborating globally to align processes, and exploring ways to utilize technology to optimize processes and enhance patient safety.

Gerrit Nijveldt is currently Labeling consultant with Opus Regulatory. Gerrit has more than 25 years of experience in Global labeling. He has a broad experience in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including the labeling for multiple development products (early phase to approval) and labeling for devices. Gerrit was also an associate adjunct professor for Temple University School of Pharmacy teaching Global Labeling in the RA/QA Master’s Program till 2022. Gerrit earned his MSc in Medical Biology from University of Utrecht in the Netherlands

Kathy Salazar is the Head of Global Labeling Implementation at Johnson & Johnson Innovative Medicine. She has over 27 years of labeling experience within J&J, including artwork development, end-to-end tracking, labeling implementation management, and labeling compliance. Kathy has an undergraduate degree from the University of Pittsburgh, graduate degrees from Rutgers and Fairleigh Dickinson University, and is recognized as a Certified Packaging Professional by the Institute of Packaging Professionals.