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.

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.

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.

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.

Lauren Brunke began her career in the Pharmaceutical Industry in 2012 when she joined Eli Lilly and Company as a fellow in the Visiting Scientist Program. Before transitioning to Regulatory Labeling, she worked as a Pharmaceutical Project Manager, where she supported products in Alzheimer’s Disease and Oncology, managed Global submission strategies, and led contractual and clinical start up activities for public-private partnerships. Currently, Lauren leads the Global Labeling Department within Global Regulatory Affairs where she oversees the development and maintenance of Core labeling and US and Canada labeling for drug and combination device products across the portfolio.

Megann Looker (BA Hons) is Head of Global Product Labelling at Jazz Pharmaceuticals, based in Oxford, UK since August 2016. She graduated from the University of Reading in 2001 after studying Classics, English Literature and Sociology, and found her way into Regulatory Affairs whilst planning a career in teaching. Megann was previously the lead for Regulatory Labeling at Celgene for the EMEA region from 2009-2016 and prior to this was in Regulatory Affairs at Wyeth and Apotex. She has served as a KOL member of LabelNet for over 8 years, and as part of the InterAssociation Task Force for IDMP, eLabelling, and DIA SIAC Patient Information.

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.

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

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.

Dr. Bass is President of Bass BioPharm Consulting Group LLC and serves as Vice President, Talent Acquisition for Ruderfer and Associates and executive Biopharmaceutical Search Firm. Dr. Bass retired from Bristol-Myers Squibb as Group Director, Global Labeling. He also had senior regulatory and clinical positions at Fujisawa and Fujisawa SmithKline Corporation, Wyeth-Ayerst and Eastman Pharmaceuticals. He received his BS in Pharmacy from Philadelphia College of Pharmacy and Science and his PhD in Pharmacology/Toxicology from Thomas Jefferson University, Graduate School of Biomedical Science. He did a postdoctoral fellowship in Cardiovascular/Pulmonary Pharmacology at the University of Pennsylvania.

Micheline leads the Advertising & Promotion and Labeling functions at Day One Biopharmaceuticals. Her experience includes Regulatory Affairs Strategy, Advertising & Promotion, and Labeling for Biologics, Drugs, and Devices. Her expertise in product launches is driven by strategic planning, risk assessment, and maintaining regulatory compliance while fostering innovation and growth. She is passionate about collaborating with cross-functional partners to drive successful product launches while ensuring adherence to complex regulations and guidances. She received her MBA from University of Southern California with a focus on Strategy and Marketing, and her BS in Biology specializing in Biotechnology from George Mason University.

Urimara Argotti is the LATAM Regional Regulatory Policy Manager, Product Development Regulatory Department at Roche based in Mexico, responsible for leading regional Regulatory Policy activities, developing and executing a regional policy roadmap and associated Roche positions to drive global regulatory convergence in LATAM. She is involved in regional and global initiatives for regulatory systems strengthening. She has over 19 years of experience in the Life Science Industry, mainly in the Regulatory Affairs, Regulatory Policy and Quality Assurance field. Active member of the Latin American Federation of the Pharmaceutical Industry (FIFARMA), Chair of the Regulatory and Biological Working Group, participates in EFPIA LATAM Network.

Jason Flint is the Associate Director for Human Factors with the Division of Medication Error Prevention and Analysis I (DMEPAI). Jason is the scientific lead for ongoing human factors research on training decay and is actively involved in guidance and standards development in the field of human factors. Prior to joining DMEPAI, Jason spent 13 years planning and conducting medical device human factors testing for the Air Force.

Misti Link is a Director of Regulatory Labeling at Vertex Pharmaceuticals and is the Cystic Fibrosis Therapeutic Area Lead for Labeling. Misti has been working in labeling for the last 7 years and in industry for over 16 years. In that time, she has served in roles across many different functions and disciplines including Operations, Quality and Regulatory. Misti lives in Indianapolis, IN with her husband and 2 girls.

Elizabeth Scanlan joined the European Medicines Agency in 2016 where she is currently Product Owner for electronic product information (ePI). Prior to joining EMA, she worked in communication roles in the biotechnology industry and not-for-profit sector. Elizabeth holds a PhD in molecular biology from Trinity College Dublin.

Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years of experience in health outcomes, drug safety and regulatory policy in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER and is an adjunct professor at the University of Southern California School of Pharmacy. She has been a pioneer in the application of Implementation Science methods within the context of drug development and has published widely in the peer-reviewed literature.

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.

Francesca is currently an Associate Director, Medicines Quality Organization (Regulatory) with over 20 years Regulatory and Quality experience in product licensing, labelling development, inspection, audit and clinical trials within the Pharmaceutical Industry. After graduating from the University of Derby she joined Eli Lilly and Company Limited as a Quality Systems Administrator and has since held a number of roles within the Quality and Regulatory organisations. In 2012 Francesca was seconded to the ABPI to support the Head of Regulatory Affairs and Drug Safety during a challenging period of regulation change. Francesca currently lives in Hampshire (UK) with her family and her horse. Interests include photography, cycling and hiking.

Heather Hammond is Associate Director, Regulatory Labeling at Regeneron where she is Therapeutic Area Lead for the Oncology and Ophthalmology labeling teams. Her feature article for RAPS, entitled “Regulatory Labeling: Preparing for Launch.” was published in Regulatory Focus in February 2019. Heather has worked in the pharma industry in the US and Canada for over 20 years, with experience across a range of labeling and regulatory functions at pharma companies, consulting firms, and Advertising Standards Canada where she was the first Director of the Consumer Drug Section. Heather holds a B.Pharm. and an M.Sc. in Pharmacology from Universite de Montreal and is a licensed pharmacist in NY.

Dr. Tomoko Osawa is Director of Office of Informatics and Management of Safety at Pharmaceuticals and Medical Devices Agency (PMDA). Dr. Osawa majored in Biochemistry and got a PhD in Pharmacy from the University of Tokyo. Dr. Osawa joined PMDA in 2005 and engaged in business related to review for new drug approvals, GCP and GLP inspections, personnel affairs and human resources development, and standards and guidelines development. Dr. Osawa has been in the current position since 2021.

Jalpa received her MSci, and subsequently her PhD in Chemistry from University College, London. She immediately began her Regulatory career working within a Consumer Healthcare organisation in 2007, managing the labeling for food and cosmetic products. From here she moved to a position at Eli Lilly, managing English language labeling utilised across multiple geographies. Jalpa held several regional labeling roles whilst at Lilly, building expertise in the Rest of World space and partnering with affiliates to ensure labeling compliance. In 2019, Jalpa moved to Vertex Pharmaceuticals (London) and is currently Rest of World Labeling lead within Global Labeling, responsible for AU, NZ, Russia, Israel and all geographic expansion markets.

Degree: PharmD from the Universidad de Costa Rica. Experience: 5 years of experience in Regulatory Affairs in Central America and the Caribbean region. Currently undergoing a Masters in Health Technology Assessment at the University of Glasgow, Scotland. -Experience in Drug Labeling, with a special emphasis in the Central American and Caribbean region and the discussions around electronic labeling in Latin America from my role as Regulatory Affairs Specialist.

As Executive Director - Head - Global Content 2 & US Labeling Strategy, Pharmaceuticals, I manage 2 group: one group focused on the strategic development and maintenance of corporate labeling and one group responsible for the management of US labeling content; SPL authoring for APIs, bulk drugs, and finished products; and import/export issue resolution. Both groups work across multiple therapeutic areas, including cardiovascular, hematology, and women’s healthcare. Prior to my 18 years at Bayer, my pharmaceutical career began with 12 years at Merck & Co., in areas of manufacturing quality, global and US labeling, and field sales.

Former Global lead for human factors at GSK, with over 20 years in Quality and Risk Management Systems, Production and Operational Excellence Julie brings a wealth of knowledge and experience to bring human performance concepts and approaches to life in a way that can facilitate application of learning directly to an organisation As a Quality and Lean professional Julie has implemented and integrated human performance and system thinking into existing global business systems strategically and tactically including Data Integrity, Quality culture and remediation work. Julie is currently a Trustee of the Chartered Institute for Ergonomics and Human Factors in the UK and leads a voluntary Community of Practice for Pharma Manufacturing.

Dr. Karthik Balasubramanian, Ph.D is Vice President for CMC and Technical Operations at Verrica Pharmaceuticals. He has over 15 years of experience in all phases of medical device and combination product development, from R&D to Technical Operations. Prior to joining Verrica, he has worked in numerous combination product and device areas in roles of increasing responsibility, from syringes to large scale diagnostic systems, as well as in sterile injectables, topicals, transdermals, and respiratory products. He has a bachelors in Biomedical Engineering from Columbia University, and a Ph.D in Mechanical Engineering from Drexel University.

Giovanna Ferrari is a Senior Director at Pfizer with over 15 years’ experience working in the regulatory sector of the pharmaceutical industry, specialising in labelling & product information since 2009. She currently works within the Pfizer International Labeling Group with regional responsibility for Europe and is also the global business owner for the Pfizer process for management of country labeling documents. Externally, Giovanna has represented Pfizer in a wide range of industry forums over the last few years, in particular focussing on e-labelling, and is the industry lead for a highly innovative and patient-focussed digital health information project that is being progressed via an IMI public-private partnership – Gravitate Health

Kim Quaintance-Lunn is the Vice President, Regulatory Affairs Americas and a Distinguished Science Fellow at Bayer, a Director at Large for the FDA Alumni Association, and Chair of DIA's Americas Regional Advisory Council. At Bayer, Kim serves in a leadership capacity for US Regulatory Affairs, functions as the expert on FDA standards, regulations, legislative actions and processes, and is the lead for several patient focused initiatives. Kim joined Bayer in February 2014 as Head of US Regulatory Policy. Kim previously served as the Senior Director, Global Regulatory Policy and Intelligence at Eisai, Associate Director for Regulatory Affairs in CDER’s Office of New Drugs, and began her career as a research scientist at Pfizer.

Vijay leads a team of global labeling strategists focused on development and marketed products across multiple therapeutic areas at Sanofi. He has worked on labeling for several new products registered in US, EU and globally. Prior to his current role, Vijay worked in areas of medical communications, evidence based medicine and drug safety & epidemiology.

Dr. Annlouise Assaf is a pharmacoepidemiologist at Pfizer. She is a Senior Director & Patient Health Activation Expert in Worldwide Medical & Safety. She evolves the science and practice of benefit risk to inform better drug development, healthcare decisions, and outcomes for patients. A focus of her work is on quality benefit risk communication and improving health literacy and patient-centered medication prescribing. This enables patients to make informed shared decisions about their treatment with their healthcare providers and improve health outcomes. She joined Pfizer in 2002 after many years in academic medicine & clinical research at Brown University School of Public Health. She has published over 100 scientific articles.

Parul has been working in Pharmaceutical Industry for 15 years. She started her career as a Retail Pharmacist. Then, she moved to Pharmaceutical Industry as a Drug Safety Scientist in Drug Safety department before moving to Regulatory affairs. She has 13 years of labeling experience in developing and maintaining Company Core Data Sheets, US Prescribing Information, and EU Summary of Product Characteristics, including creating Target label for the development product.

A regulatory labeling expert with over 15 years experience managing the core datasheet and labeling negotiations. A team leader in the Labeling Strategy & Development group at GSK.

North Star : Believe that detailed knowledge is key to designing, implementing and maintaining solutions Education/ Experience: Post Graduate Qualification in Pharmaceutical Engineering from the University of Manchester Over 20 years working within the Pharmaceutical & Medical Device Industries. Specialties : Automation, Sterilization, Serialization & Product Tracking, ePI+ (electronic Product Information with built in Anti-counterfeit functionality)