Terry has been in the pharmaceutical industry since 1993. She has supported Regulatory Affairs and Product Information areas throughout that time. Since 2003, she has worked with US and Global Labelling in Operations and Compliance areas. Her current role of Compliance Director assures that regulatory labelling throughout the local operating companies within GSK are managing their compliance with labelling safety updates. Historical note: She led the Structured Product Labeling Working Group Leadership Team, a group representing manufacturers, vendors, downstream users and the FDA in the varied uses and challenges of SPL, through 2019.

Kelly is a Consultant in Global Regulatory Affairs at Eli Lilly and Company. She began supporting labeling in 2012 in a Regulatory QA role and became the Global Labeling Process Owner in 2016. She has had various roles in quality supporting printed packaging materials and printing/packaging, and in post-approval CMC Regulatory. As Process Owner, Kelly ensures that labelling processes are compliant with global requirements and oversees the creation and maintenance of procedures to ensure they accurately reflect the processes. Her contributions include establishing a process to support a digital library of images for use in printed packaging materials, and leading a team to change the document management system for labeling authoring.

Paula is an Advisor in Global Regulatory Affairs at Eli Lilly in Indianapolis, Indiana where she currently leads the Regulatory Information and Process Automation group. She received her BS in Pharmacy at Purdue University. Her first role in regulatory was in 2004 as the Director of Site Regulatory Affairs overseeing the CMC Post-Approval organization. Determining Regulatory Affairs would be her home, she took a role in US Advertising and Promotions before arriving in the Global Labeling Department in 2012. Paula served as Process Owner for Global Labeling where she led the improvement of critical processes and the implementation of an end to end labeling tracking system. She is currently leading the implementation of a RIM platform.

Su has held various levels of positions at Intercept, Regeneron, BMS, and former Wyeth with global regulatory labeling and promotion responsibilities in different therapeutic areas for small molecules and biologic products. Su specializes in end to end labeling process with emphasis on Target Labeling planning, Labeling Strategy in Product Development, and Labeling and Promotion Process and Compliance. Su was the Co-Chair of Labeling Working Group for the DIA Regulatory Affairs Community organizing Labeling Conferences and Hot Topics sessions. She is a registered pharmacist and holds a MS degree in Hospital Pharmacy Administration.