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 SVP Head of Regulatory Affairs and Medical Writing at PepGen Inc. a company developing treatments for rare neuromuscular diseases.

Kelly M. Treonze, MS, Head, Global Labeling Therapeutic Area, Merck & Co., Inc. Kelly leads the Global Labeling Therapeutic Area at Merck which is part of Global Regulatory Affairs and Clinical Safety. In this role, Kelly leads a team of 50+ labeling professionals who support the labeling strategy and development for Merck’s marketed and developmental products. This includes the early developmental labeling and life cycle management of Core Labeling, US Labeling, and Local Labeling for Merck’s products globally. Kelly began her career at Merck within Discovery as a bench scientist, after working in academia. 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.

Sylvie is the Head of Global Labeling at Ipsen, based in France, where she leads a team responsible for managing Company Core Data Sheets and overseeing End-to-end labeling. She has been working for over 25 years in the pharma industry at large & small companies, with 15 years in labeling, at Sanofi Aventis and then GSK where she was strategic labeling lead for worldwide and EU-US region. While labeling became a true passion, she brings also experience from Quality Assurance as she worked previosuly as a GCP auditor and adpromo global Compliance. Sylvie is passionate about developing her team, enjoy process optimization and multidisciplinary interactions.

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 Operations at Johnson & Johnson Innovative Medicine. She has over 28 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.

Sam Kay is a strategic Regulatory Affairs leader specializing in all things Pharma at Basil Systems. With over 12 years of experience, he has driven global labelling initiatives—from clinical development through commercialization—ensuring that products meet rigorous regulatory standards across key markets. A Master of Pharmacy graduate from Kingston University London, Sam has a proven track record engaging with Health Authorities such as the EMA, FDA, and MHRA. Passionate about leveraging technology to enhance regulatory practices, his innovative approach to labelling and compliance continues to set industry benchmarks and inspire forward-thinking solutions in pharmaceutical product development.

Jamie is the Director of Client Success at Glemser Technologies. He advises clients on innovation strategies and enterprise wide cloud technology transformations that save time, save money, increase compliance, and improve quality. Jamie has deep technology, business transformation, and benefit realization, experience across the life science and healthcare industries. Jamie is a proven leader who has run large scale, multi-year enterprise engagements across complex ecosystems.

Hemant Patel is Regulatory Scientist at Eli Lilly and Company. With over 15 years of experience in the field product development, Hemant has led numerous projects with regulatory compliance in the pharmaceutical and aerospace industry. He received a MSEE from Purdue University, holds several patents related to medical devices and is an active AAMI member. He is an advocate for staying up to date and researching how technology can be utilized in pharmaceutical product development while meeting the latest regulatory standards.

Urchena Tewari is an Associate Director and Global Labeling Product Leader at J&J Innovative Medicine, where she is responsible for target label development and formulating labeling strategies to support new product filings. With a passion for labeling in Cell and Gene Therapy Products, she's currently leading an initiative focused on this innovative area. With over 20 years of experience in Global Labeling, Urchena began her career at the MHRA before joining GSK. She subsequently worked as a labeling consultant for over 10 years, contributing to diverse projects, including multiple global labeling compliance projects. Urchena joined J&J Innovative Medicine in 2021. She holds an MSci in Chemistry with Bioscience from King’s College, London.

Pat is a board-certified rheumatologist with 20 years of pharmaceutical industry experience in various stages of the life cycle management for biologics in immune mediated diseases and fertility, small molecules for immuno-oncology, cardiovascular, hematologic malignancies, enzyme replacement therapies and anti-sense oligonucleotides for rare disease indications. She has served at levels of increasing responsibility in PV at Genzyme, EMD Serono, Sanofi, Ionis and Nimbus Therapeutics. She currently serves as VP Pharmacovigilance at PepGen Inc in Boston.

Julie Guery is the Global Regulatory Affairs Labeling Head at Sanofi, leading a team of 50+ professionals focused on Labeling Strategy, Innovation, and Operations. She supports a broad portfolio across Inflammatory & Immunology, Rare Diseases, Oncology, Vaccines, and General Medicine, from early development through lifecycle management. With 17+ years of experience in pharmaceuticals, consumer healthcare, and cosmetics, Julie has developed global expertise, particularly in Europe, the US, and Asia. Holding a Ph.D. in Physical Chemistry, she combines scientific knowledge with strategic leadership to drive innovation and team development. Julie is committed to advancing public health and fostering excellence in the industry.

Kathleen began her career in the Pharmaceutical Industry at Eli Lilly and Company in 2011. She brings 9 years experience supporting global core, US, and Canada labeling for small molecules, biologics and combination drug labeling. Prior to transitioning to Regulatory Labeling, she helped build the Clinical Diagnostics Laboratory, spearheading the establishment of Lilly’s first CLIA accredited laboratory. With a 22-year background in hospital regulated clinical laboratories, she held roles in multiple disciplines, collegiate allied health education, management and served as a US laboratory peer inspector for the College of American Pathologists. She has a dedication to quality, team success and a passion for innovative labeling solutions.

After obtaining her MSc in Biomedicine, Irene began her career in various science and health communication roles at non-profit organizations. She then transitioned to Regulatory Affairs, where she worked for 14 years as a local and EU Regulatory Manager at the Dutch Bayer affiliate, supporting various therapeutic areas. In 2023, she took on her current role in global labeling, where she leads initiatives on patient-friendly labeling and the implementation of AI in Regulatory Affairs. Irene is passionate about improving healthcare communication and leveraging technology to enhance regulatory processes.

Megann Looker (BA Hons) is Head of Global Product Labelling at Jazz Pharmaceuticals, based in Oxford, UK, overseeing a global remit. Having graduated from the University of Reading in 2001 after studying Classics, English Literature and Sociology, Megann found her way into Regulatory Affairs whilst planning a career in teaching. Over the past 23 years, Megann has held key roles: previously the lead for Regulatory Labeling at Celgene for the EMEA region from 2009-2016, and prior to this, Regulatory Affairs at Wyeth and Apotex. She has served as a KOL member of LabelNet for over 12 years, and was formerly a member of ePI and IDMP Task Forces across Europe.

With over 18 years in the pharmaceutical industry and more than 16 years in regulatory affairs, Marva Schödel is the Senior Director of Regulatory Affairs, Global Labeling Therapeutic Area Lead, and Health Literacy Lead at Merck & Company. She is committed to developing patient-centric labeling strategies that enhance health literacy across diverse populations. Marva leads cross-functional teams to ensure clarity and compliance in product information, focusing on improving patient outcomes. As an advocate for clear labeling, she emphasizes the role of health literacy in supporting informed patient decisions. By integrating these principles into regulatory practices, Marva focuses on inclusive communication that fosters accessibility.

Mike is a consulting professional with over 15 years of Healthcare and Pharmaceutical Industry experience. His range of experiences span from product development and Health Authority interactions to R&D functional strategy and management. Mike currently leads PwC’s Regulatory Advisory Services team, supporting regulatory leaders across the life sciences industry address organizational priorities and navigate disruptive technologies. His areas of expertise include: organizational strategy, operating model design, technology enablement, and digital disruption.

Yaroslav Ivanov is a Senior Director of Global Labeling Strategy, Team Lead, Marketed Product Development at Bristol Myers Squibb Company (BMS), with 14 years of labeling experience in the pharmaceutical industry. In this role, Yaroslav is responsible for leading the team of global labeling strategists responsible for developing labeling content for all BMS approved products. Prior his current position, Yaroslav was a Director, Global Labeling Lead for Immunology and Rare Blood Diseases products at Sanofi. Prior to labeling, he completed a Fellowship program in Global Medical Safety at Johnson & Johnson. Yaroslav has a PharmD and a Bachelor of Arts in Biology degrees from Rutgers University.

Global Regulatory Affairs professional with large and mid-Pharma experience covering research, drug development and regulatory labeling strategy. Experienced in leading multi-disciplinary, geographically diverse teams.

Vladimir Penkrat is AVP of Regulatory Affairs at Indegene. With an MBA in International Business, Vladimir has provided strategic leadership throughout his career across clinical development, biometrics, biostatistics, medical writing, pharmacovigilance, and regulatory affairs. Over the past three decades Vlad worked across top pharma, biotech startups, CROs, and consulting firms. Within the recent 10 yrs, Vlad's passion for regulatory excellence has established process leadership in Regulatory Writing, Submissions Management, Publishing, Labelling, CTT, Consulting, & GenAI innovation as a business. Vlad's leadership has enabled businesses to prepare for digital adeptness & as a business leader he has scaled R&D operations to >500 FTE.

Karel van der Waarde studied graphic design in the Netherlands (The Design Academy, Eindhoven), and the UK (Leicester and Reading). He started in 1995 a design - research consultancy in Belgium. Most of the projects are related to information about medicines for patients, doctors and pharmacists. (www.graphicdesign-research.com). In 2023 he teaches at BA, MA, and PhD level at the Lucerne University of Applied Sciences and Arts (Switzerland), and University of Hasselt (Belgium). He is a board member of International Institute for Information Design (IIID, Vienna, Austria) and the International Plain Language Federation (IPLF), and editorial board member of Information Design Journal, Hyphen, She Ji, and Visible Language.

Tara is the Head of Global Labeling at Gilead Sciences, bringing over 25 years of global experience in pharmaceutical and medical device labeling. She has held key roles at industry leaders such as Takeda, PRA (ICON), AbbVie, Boston Scientific, and Wyeth (Pfizer), where she developed a strong passion for End-to-End Labeling Management, from safety through distribution. As a member of Gilead's Innovation, Content, and Operations Leadership Team, Tara is dedicated to driving labeling innovation and continuous improvement in labeling strategy, content, and process. She is the founder of Leaders in Labeling, a collaborative network of thought leaders in labeling for regulated products, including pharmaceuticals, biologics, and medical devices.

At AbbVie, Young is managing human factors engineering activities to design, test, and validate the combination products and medical devices as well as digital health. Prior to joining Abbvie, Young led the human factors team in Alexion Pharmaceuticals, a rare disease business subsidiary of AstraZeneca, and oversaw human factors engineering processes. Before Alexion, Young worked at Takeda, Shire, and Biogen in medical device and combination product development as a human factors lead. She holds a Ph.D. in Industrial Engineering specializing Human Factors from Texas Tech University and BS and MS in Industrial & Information Engineering from Hongik University, South Korea.

Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of EU clinical guidelines for drug development. In 2005 he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and Healthcare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences. In 2017, he was appointed Head of Public and Stakeholders Engagement Department and is Co-chair of the EMA patients’ and healthcare professionals’ working party.

Lori LaRosa holds a Doctor of Pharmacy degree from Mercer University and a Bachelor of Science in Industrial Chemistry from Middle Tennessee State University. Currently, she is a Senior Director of Regulatory Affairs, Global Labeling at Merck in the oncology therapeutic area. Lori has also held roles at Merck in promotion and advertising regulatory review and in global medical information. Her experience spans managing labeling strategies, training students, interns, and new employees, and ensuring compliance with regulatory standards. Prior to Merck, Lori worked as a clinical pharmacist at the Hospital of the University of Pennsylvania, focusing on anti-infective stewardship and clinical nutrition support.

Jackie Mowry is the Global Labeling Compliance Director at Novartis, leading a team with responsibilities including oversight of safety label change implementation, driving process improvements, audit and inspection readiness, and ensuring continued compliance. Prior to joining Novartis in 2015, Jackie held the role of Artwork Compliance Director at Merck, where she oversaw the development of artwork to ensure regulatory compliance and consistency across Merck brands, as well as key initiatives including implementation of serialization and anti-counterfeiting measures. With over 20 years of experience in labeling, Jackie remains focused on compliance, regulatory excellence, and fostering a collaborative and performance-driven team.

Yuri Quintana, Ph.D., is Chief of the Division of Clinical Informatics at Beth Israel Lahey Health and Assistant Professor of Medicine at Harvard Medical School. His research focuses on learning health networks and online platforms that empower patients, families, and health professionals. He developed InfoSAGE, a mobile app for home-based coordination for medication and symptom management, and Alicanto Cloud, an online platform for learning and collaboration to disseminate best healthcare practices and virtual consultations. Quintana obtained his engineering degrees from the University of Waterloo in Electrical and Computer Engineering and Systems Design Engineering. More at http://www.yuriquintana.com and on Twitter at @yuriquintana.

Michelle Wu is the founder and CEO of NyquistAI, with over a decade of experience in pharmaceuticals, medical technology, and digital innovation. She has been featured by Forbes and has spoken at various conferences on AI in life science. Before founding NyquistAI, she was the youngest global strategy manager at Novartis, where she played a pivotal role in the industry’s first and only asset swap deal between Novartis, Eli Lilly, and GSK. This experience highlighted the challenges of manual data research, sparking her vision to create NyquistAI. Before Novartis, she worked for BCG, advising major pharma and Medtech companies on their global product development and emerging market strategies. She holds an MBA from Stanford University.

As Director, R&D Lead at Pfizer, Craig Anderson is responsible for research, development, business and process-related functions across the International Labeling organisation. This includes topics such as electronic labelling, medicinal product information, digital health, and data standards. Craig is also Co-lead of HL7’s Vulcan accelerator project for electronic Product Information (ePI) and co-lead for HL7's Pharmaceutical Quality (Industry) project.