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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Maslinda Mahat has dedicated nearly two decades of her professional career to working in the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. She currently holds the position of Head of Policy and Strategic Planning at NPRA. Graduating as a pharmacist, she pursued her MSc in Pharmaceutical Biotechnology at De Montfort University of Leicester. Embracing the evolving landscape of pharmaceutical regulation, Maslinda Mahat has been deeply involved in the planning and implementation of e-labeling for pharmaceutical products in Malaysia since 2021. The journey commenced with the groundbreaking use of e-labels on COVID-19 vaccines, marking a significant leap forward in regulatory transparency and efficiency.

Evi is the Life Sciences Industry Leader at Appian. He is an experienced pharmaceutical executive with an extensive background developing global business portfolios with emphasis on new products, technologies, and IP. Previously, as Global Head of Life Sciences at ServiceNow Evi lead the Life Sciences strategy and solutions approach to creating value for patients. Prior to ServiceNow Evi was VP Global Life Science & Healthcare at Appian, VP Global Innovation at Catalent and held roles in Legal Affairs, R&D, Clinical Operations, Quality, CSV, Regulatory Affairs, and Program Management. He holds an M.B.A. in Pharmaceutical Management, MIT Certification in AI, M.S. in Biotechnology, and a B.S. in Chemistry.

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

Wanda Rosado is the End to end Labeling Process Lead, in Global Strategic Regulatory Operations at Bristol-Myers Squibb. Her pharmaceutical career spans 35 years. Wanda has held positions in Clinical Biostatistics, Regulatory Operations and worked as an IT Business Partner facilitating strategic projects, driving process improvements, and supporting change management. Wanda is a Lean Six Sigma Black Belt and has a B.S. degree in Biomedical Computer Science from Rochester Institute of Technology. Within BMS she led RIM Services (using Veeva RIM Vault) and helped expand the E2E label tracking from HA Approval to Implementation in the market by deploying new processes in Supply Chain for Artwork Management and Implementation Planning.

Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as a guest reviewer from 2002-2003, and in EMA as the Japan Liaison Officer from 2012-2014. She is actively involved in many academic societies, and contribute them as counselor, committee member, and a board member.

Jennifer Sekawungu is a Director, Global Labeling Product & Initiative Leader at Johnson & Johnson Innovative Medicine, Real World Evidence (RWE) Initiatives leader. Jennifer is responsible for building capabilities within Global Labeling to drive labeling content strategies for New Molecular Entities and Line Extensions, incorporating RWE to support regulatory submissions. Jennifer is a seasoned labeling professional with 25 years of experience in the pharmaceutical industry of which 16+ years have been in Global Labeling. She started her labeling career at Merck & Co., Inc. before joining Janssen in 2016. Jennifer holds a Master’s Degree in Biotechnology from Northwestern University.

I have a BS Degree in Chemistry and worked as a chemist in several industries on the east coast until I started in Pharmaceuticals at Merck. After a few years I moved to the Midwest with Eli Lilly and have been here 21 years. I have worked in Quality Assurance, Printed packaging labeling support, and have spent the last 11 years in the Global Packaging - Labeling organization. I work with a great team who support the strategy and overarching processes for Artwork Labeling development globally at Eli Lilly. We are passionate about excellence in all aspects of labeling processes as we pursue the lofty ideal of Best in Class.

Nancy is heading up the Global Labeling Organization, including the Global Labeling Content & Strategy group as well as Global Implementation, for J&J Innovative Medicines. The organization consists of the Global Labeling Product Leads in charge of target labels, primary labels and label updates for the different Therapeutic Areas (oncology, immunology, neuroscience, cardiovascular, pulmonary hypertension, global public health), as well as Global Implementation Managers. Prior to heading up Global Labeling, Nancy has been working within GRA in different functions, as GRA Head of Vaccines TA responsible for GRLs developing global regulatory strategies. Prior to J&J, Nancy worked at Merck and GSK Vaccines.

Kiran Chinnalla is Director at IQVIA and is responsible for managing product development and maintenance in regulatory affairs. He has over 16 years of experience in regulatory & labelling strategy, patient safety, project management, product strategy and consulting. Kiran is a pharmacist by qualification with a post-graduate in pharmacology.

Juan has been with Appian for four years and currently serves as the Process Automation Technology Lead for Product Strategy. Prior to joining Appian, Juan worked for over 15 years as a consultant and independent contractor, leading customized software development projects for medium and large organizations. He earned a B.S. in Electrical Engineering from the Polytechnic University of Puerto Rico and an M.B.A. from the University of New Orleans.

Tracy Nasarenko, vice president of Community Engagement at GS1 US for Healthcare, has more than 20 years of experience in healthcare and pharmaceutical supply chain, finance, product management, marketing, and operations. Currently, she leads a collaborative healthcare industry group focused on addressing supply chain challenges and meeting the requirements of regulations like the Drug Supply Chain Security Act (DSCSA). Using GS1 Standards, the most widely used supply chain standards in the world, she guides the implementation of these standards to help the pharmaceutical industry deliver safe products to patients. She earned a bachelor’s degree from Villanova University and a Master of Business Administration from West Chester University.

Koen Nauwelaerts holds a Master’s degree in Pharmacy from Leuven University, Belgium and a PhD in Drug Development from the same university. Further he obtained an MBA degree from Vlerick Business School and completed the technology immersion program at MIT. Koen is currently working at Bayer as RA Policy and Innovation Lead. He joined Bayer as head of regulatory affairs and quality for the Belgium/Luxemburg region and previously has been active within MSD and Medicines for Europe in different roles in Regulatory Affairs and Quality. Within his current role as RA Policy and Innovation Lead, Koen leads the internal global e-labeling initiatives at Bayer and is vice-chair of the Inter Association TaskForce (IATF) for ePI.

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.

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.

Catherine Skobe, Sr Director, has been the Publications Management Team Leader at Pfizer since 2017. Prior to joining Pfizer in 2007, she worked at IntraMed, Becton Dickinson, and at UNC Hospitals. Catherine is a member of ISMPP where she has held several roles and currently co-chairs the Patient Engagement Task Force. She is also a member of Open Pharma and sits on the Vision Task Force. Catherine received her MPH with a concentration in Community Health Education from Hunter College and earned a BS in Medical Technology from the University of North Carolina at Chapel Hill. She is a certified Medical Technologist (ASCP).

Shaun Wallisa began his career in the Pharmaceutical Industry in 2000 when he joined Pharmacia and Upjohn as an Analytical Chemist and then moved to Eli Lilly and Company in 2002. Before transitioning to Regulatory Labeling, he held several technical and leadership positions within the manufacturing organization - Quality Assurance, Quality Control, Procurement, Continuous Improvement, and Technical Services. Currently, Shaun leads the Global Labeling Department within Global Regulatory Affairs where he oversees the development, implementation, and maintenance of Core labeling and US and Canada labeling for drug and combination device products across the product portfolio.

David is a health information designer from a consumer campaign background. He worked for the UK Consumers Association as editor of Health Which? magazine. As a founder of Consumation he then worked on patient advocacy projects including Ask About Medicines Week, and the Compliance to Concordance initiative. David and the team at Consumation were early practitioners of usability testing for patient information in Europe, following the work of David Sless and colleagues in Australia. Consumation has worked with government agencies, pharma firms and professional bodies to put across complex messages in simple language. In 2015 David was made an Honorary Member of the Faculty of Public Health.

Since 2016, Dr. Gordon has been a lead for data standardization efforts including those for pharmaceutical quality, manufacturing, and labelling, as well as real-world data derived from health information technology for use in clinical research and pharmacovigilance. Before arriving at FDA, Dr. Gordon received his core scientific training with a Ph.D. in Molecular Microbiology from Tufts University Medical School, entered the public health domain in 2005 working on public health emergency preparedness and from 2011 with a focus on public health informatics.

Dr. Niklas Jänich is Head of Global Labeling Operations & Digitization at Boehringer Ingelheim. In this position Dr. Jänich is responsible for Labeling process, systems, compliance and digitization as well as for driving the implementation of structured content management in the GxP-regulated Labeling process. Dr. Jänich is a certified pharmacist and holds a PhD in medicinal chemistry and a Master of Drug Regulatory Affairs.

Mohamed Oubihi is the President and CEO of Yakumed, a one-stop niche service provider that is fully specialized in the Japanese pharmaceutical market. Yakumed has supported over 70 pharmaceutical/biotechnology companies to strategize, develop, approve, and launch their drugs in Japan. Mohamed has 24 years of experience in the Japanese bio and pharmaceutical sector. Ex-Vice Chairman of the Japanese Association of Additives Enzyme committee. Ex-Head of Amicus Operations in Japan. He assumed leading positions in several pharmaceutical companies. Strong Negotiation Experience with PMDA/MHLW. Wide network in the Japanese pharmaceutical Industry. Mohamed served as an expert witness in international arbitrations involving Japanese companies.

Aliza has over 20 years of experience in the biopharmaceutical industry. She is an expert in structured content authoring, component content management, and content reuse. Over the last several years, she has used her extensive and varied expertise to evolve a theoretical enterprise content strategy into sustainable content operations for the Roche pharma organization. She collaborates with various organizational units to standardize content practices, implement structured content management technology solutions, and drive results that align with future work paradigms.