Senior Director of Global Regulatory Systems, overseeing the implementation, support and development Eisai's Regulatory technology strategy. Active member of IRISS and Committee Member in PhRMA's Regulatory IT Workstream. Prior to Eisai, performing similar roles in supporting the Regulatory functions at Big Pharma, Consultancies and mid-size biotech's for the past 20+ years.

Noelia leads Daiichi Sankyo’s Process Excellence & Analytics group for Global Regulatory Affairs. She is responsible for managing GRA’s controlled procedural documents, optimizing global processes, ensuring compliance, and delivering metrics that support data-driven decision making in Regulatory. She began her career at Accenture and joined Daiichi Sankyo in December 2022. During her tenure at Accenture, Noelia partnered with a variety of sponsors on global transformation programs across Clinical and Regulatory, with a focus on improving processes with enabling technologies.

Jonathan Resnick is an advisor for FDA's Office of Digital Transformation, with a focus on eCTD and has been with FDA since 2011. In addition to eCTD, Jonathan is the FDA Topic Lead on the ICH M8 Expert Working Group and FDA's Chair for the PDUFA Information Management Working Group. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

German citizen, who worked in Switzerland and now lives in the US. I have been in the Pharmaceutical Industry for my entire career. I looked at Content Management from many different angles: Information broker, information architect, solution engineer and end user in various business domains and regions. The time is now to prepare for fundamental change in RIM. We have done Document and Data Management in silos for decades. The past couple of years AI dominated the solution space with various success. It is time to fundamentally rethink how we work with content and design business centric solutions that actually deliver desired results.

Alisa has 20+ years of experience spanning regulatory, quality, and technology consulting, she brings a pragmatic, execution driven perspective to complex regulatory and data challenges. She has successfully guided enterprise organizations through large scale system implementations, data harmonization initiatives, and process transformations, with a focus on enabling compliance, operational efficiency, and long term value realization. As Manager of Regulatory Information Management & Technology at BioMarin, Alisa supports regulatory teams through the optimization of Veeva based systems and enterprise technology initiatives. She is a Certified Veeva Associate Administrator, ScrumMaster and an active member of DIA.

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.

Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 36 years of experience. During his long tenure, he has been responsible for the introduction of Web, document management, global team collaboration, and regulatory information management applications to large pharma. Until recently, Bala was Head of the Healthcare and Life Sciences at Orion Innovation. As an entrepreneur and a thought leader, he has been involved in initiatives to transform regulatory affairs from a document-centric function to a data-driven function. Bala has been associated with DIA for more than 17 years, leading DIA RIM Reference Model workstream and DIA AI Consortium Regulatory Frameworks and Terminology workstream.

Kunal Lal is a UK-based Consultant with Red Nucleus and a subject matter expert in Regulatory Information Management and IDMP/XEVMPD. He has over 13 years of experience working across the Regulatory, Pharmacovigilance, Clinical and Supply Chain functions of pharmaceutical organizations, with robust knowledge of related regulations, processes, and systems. Kunal has led and contributed to many projects for regulatory readiness, process assessment, definition and optimization, data maturity assessment and governance and application support and maintenance.

Handsome Ji is a recognized expert in regulatory operations and eCTD. Since 2015, Ji has chaired DIA China Annual Meeting sessions, including ICH Theme Day and CTD/eCTD workshops. He served as advisor to the DIA China Young Professionals Committee and co-lead of the RA Community Core Working Group. Ji co-led the RDPAC China Regulatory Requirements Working Group and lectures at the NMPA Institute of Executive Development. He also leads industry courses at Fudan University and contributes to global DIA programs. Ji holds a bachelor’s degree in Computer Science and Technology from Fudan University.

Mr. Senay is a strategic leader specializing in healthcare informatics innovation and regulatory science advancement. He focuses on implementing transformative informatics solutions that accelerate the development and approval of safe, effective medicines for patients. His work directly supports the FDA's mission to protect and promote public health through evidence-based regulatory decision-making. As a U.S. Excellence in Government Leadership Fellow, Mr. Senay has demonstrated exceptional capability in leading complex initiatives that deliver measurable outcomes for public health. He holds a Master's degree from The Johns Hopkins University and maintains certification as a Program Manager, bringing both academic rigor and practical exp

With over 20 years of experience spanning Commercial, Regulatory, Medical, Clinical, and IT functions across the pharmaceutical and software industries, Lorelle has led technology-driven initiatives that advance regulatory operations, digital transformation, and strategic objectives across both industry and health authority environments. Leveraging a unique perspective gained from working across the broader regulatory ecosystem, Lorelle now focuses on global regulatory intelligence, emerging technologies, and regulatory modernization initiatives. Her work centers on translating regulatory and market insights into strategic guidance that fosters innovation, collaboration, informed decision-making, and corporate growth.

Jennifer Dames is Director, Regulatory Submissions at AbbVie. She has over 10 years experience in Regulatory. Jennifer has experience with implementation of Regulatory Information Management systems, Document Management, Submission Management, Publishing, and system support.

Katherine Novak provides experience as a strategic consultant across the full drug product lifecycle, including Clinical Operations, Regulatory Operations, Regulatory Informatics, Pharmacovigilance, and large-scale Manufacturing. Katherine supports clients in global Regulatory strategy, digitalization, system implementation, process development, and data quality. Her passion is in data standard harmonization and collaboration, specifically submission data and optimization for Regulatory decision-making.

Rachel has 14+ years of experience in regulatory operations and helping sponsors achieve their eCTD submission goals. She has led the eCTD submission publishing of a variety of application types for different regions, from small amendments to large-scale original marketing applications, as well as mentored and trained others in eCTD publishing and submission management. She has also spoken at industry conferences on topics pertinent to investigational and marketing related submissions and produced a variety of blogs, presentations, and other materials to share valuable industry insights.

Aliza began her career on molecular teams and leading complex regulatory submissions. Over her 20+ years in biopharmaceuticals, she has expanded her focus into automation-assisted content authoring, generation, and management. Today, she leverages her foundation to drive content innovation within Roche, transforming theoretical strategies into scalable, sustainable operations. Known for her collaborative leadership, Aliza partners across regulatory, technology, and business units to shape, standardize, and implement solutions that anticipate the future of work. She is passionate about building adaptive, compliant systems and processes that empower teams to deliver in an ever-evolving regulatory landscape.

Rita Algorri, PhD is an Associate Director, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. In this role, she leads and orchestrates internal and external activities relating to regulatory modernization, digitization, automation, and emerging technologies. She also serves within Amgen’s Advocacy and External Engagement function which fosters collaboration with multiple internal and external cross-functional teams to coordinate and progress company and industry initiatives. Rita is a microbiologist by training and holds a PhD in Clinical and Experimental Therapeutics and M.S. in Regulatory Science from the University of Southern California.

Ashley is Head of Global Regulatory Policy for Accumulus Synergy. With over 19 years of experience in the federal government and industry, Ashley advocates for policies that will advance digital transformation. Prior to her time at Accumulus Synergy, Ashley was with the U.S. Food and Drug Administration, where she worked in various policy offices in the Center for Drug Evaluation and Research, such as the Office of New Drug Policy, the Office of Generic Drug Policy, and the Office of Regulatory Policy. Ashley has her B.S. from the Pennsylvania State University and her Masters of Public Health from the University of Maryland.

Experienced Regulatory Affairs Delivery Manager & Business Solutions Expert with a strong background in project management, advisory services, business analysis, and departmental support within the pharmaceutical industry. Certified Veeva Vault Platform Associate Administrator and recognized Regulatory Operations Subject Matter Expert (SME). Skilled in managing and optimizing multiple electronic document management systems (eDMS), with a focus on business administration, cross-functional alignment, and industry best practices. Adept at stakeholder engagement across all organizational levels, consistently maintaining a a customer-centric approach and high attention to detail.

Theresa has over 20 years of experience in the life sciences industry, where she has developed and delivered innovative and user-friendly solutions for regulatory, clinical and QA processes. She is currently provides ad hoc Regulatory consulting at Kivo, a company that provides a unified cloud-based platform for managing regulatory activities and content, TMF and QMS documents. She is passionate about empowering emerging life science groups to accelerate their research and development and bring their products to market faster and safer. She fosters a culture of inclusion and collaboration within teams, leveraging her diverse background in library and information science and her global experience with various pharmaceutical clients.

Kevin Tompkins is the Executive Director, Regulatory Information and Submission Management at Bristol Myers Squibb. He joined BMS in 2018 and has over 20 years of experience in different roles leading regulatory operations teams. In his current role, Kevin is responsible for the strategic direction and delivery of regulatory submissions, product data, and regulatory systems for BMS. He holds a B.S. in Information Systems and a M.B.A. from LaSalle University.

John is a skilled and versatile life science professional with 6 years of industry experience and a robust scientific background, including over a decade of research in chemistry with conference presentations and journal publications. As a certified change practitioner with (agile) project management certifications, John combines strong analytical skills, a hands-on mentality, and a solution-focused mindset helping regulatory teams manage data more effectively, drive digital transformation, and stay ahead in a changing industry.

Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market strategies and data harmonization. She was named PharmaVoice’s top 100 most inspiring individuals for Mentorship and Team Development and received the esteemed Excellence in Service award from DIA. Brooke has an integral role in shaping the discourse surrounding data and technology in regulatory affairs through her work with DIA as programming chair for the Data & Technology Track and as the co-chair of the DIA RA Community.

Joan Cheung is a Senior Consultant at Epista Life Science where she leverages new technologies for digital transformations in the life sciences. Since her Doctor of Pharmacy from St. John’s University, she gained technical project and product management skills in Regulatory Affairs with projects spanning structured content authoring, IDMP compliance, and data standardization. She is excited to share Epista's successes in driving data standardization initiatives and future proofing companies for global health authorities' requirements. Outside of work, Joan is advocating for AANHPI civil rights across NYC as a board member of OCA-NY, a national 501(c) nonprofit. She is also pursuing a Master of Data Science from Brown University.

Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development, clinical research, and consulting and his 20-year engagement with CDISC includes roles as a volunteer, implementer, and board member. Chris is passionate about leading CDISC towards a technology-based standards future and expanding the organization's global impact in clinical research standards.

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., a global Life Science benchmarking and advisory firm specializing in performance improvement, strategy, industry analysis, benchmarking and organizational transition. His early career was spent at Johnson & Johnson in a variety of management positions and then transitioned to consulting where he lead global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton. His organization is well known for their insightful industry benchmarks and World Class RIM thought leadership. Steve has a Bachelor’s of Science in Business Computer Science and a Master in Organizational Development and Performance.

Sandy Krogulski is an experienced and solution-oriented individual with over 10 years of submission and regulatory experience. Sandy joined BMS in 2018, working on global submissions and process evolution. In her current role, Sandy leads regulatory digital strategy and external engagement for Global Regulatory Sciences at BMS, where she sets the vision and roadmap for how the organization modernizes the way it authors, manages, and delivers regulatory submissions. She helps identify, prioritize, and scale high-value digital and AI use cases, from content authoring automation to knowledge reuse and regulatory intelligence, while keeping regulatory rigor front and center.

Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory Innovation in early 2022 coming from Amgen where he was heading Global Regulatory Operations. As part of his role at Accumulus, Dominique is supporting global Accumulus platform adoption from Health Authorities and Biopharmaceutical organizations. Dominique is also a Board Member of IRISS Forum since 2021. Dominique holds a Pharm D and a master’s in International Regulatory Affairs from the University of Paris.

Mr. Lantzy has over 20 years experience solving technology and people problems in government, vendor, consulting, and industry environments. He is a former member of CDER's Electronic Submission Support Team at the US FDA and currently leads the Global Regulatory Affairs Operations team at Novavax, Inc. His current interest is on improving the exchange and review of data between industry and regulatory health authorities, to ultimately provide safer and more effective products to patients and for public health.

David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics industry. In his Global Regulatory Policy role, David is actively involved in Reliance and Collaboration efforts at AZ. David is Bio Representative in the ICH Task Force for PQKM Feasibility Assessment. As the GSO IRISS Lead (2016 to present) David hosts monthly meetings on Regulatory Submission and Data innovation. As AZ Lead for PhRMA IT Group (2014 to 2023), David helped lead the PhRMA IT White Paper on Cloud based computing with global collaboration.

Patricia entered the Life Sciences Industry in 1994 starting her career at Schering-Plough in Kenilworth, NJ and later joining Boehringer Ingelheim Pharmaceutical in Ridgefield, CT. Within both organizations she took a leading role in transitioning business processes, document management and submission compilation from a paper to electronic system. She is a member of Regulatory Affairs Professional Society (RAPS) and has also earned her Regulatory Affairs Certification (RAC) from RAPS and the Regulatory Affairs Certification Board (RACB). She is also a member of the Drug Information Association (DIA) and a member of the TMF Reference Model Working Group (sponsored by DIA).

Kristen has 20 years of experience helping life sciences clients create modern and innovative regulatory practices and processes that leverage cutting-edge technology to satisfy both FDA requirements and their bottom line. She has built and led global regulatory operations and project management teams for top industry organizations using forward-facing strategy and business systems. Her experience includes comprehensive knowledge of electronic submissions requirements, connections into e-subs group, strong experience in pharmaceutical process and submission preparation through pre-market and NDA stages of development, and strong exposure and awareness of post-marketing and international filings.

Donna Yosua leads the Merck Data Harmonization & Interoperability program which includes the implementation of a regulatory data hub and canonical data model with reusable data publications, reporting and analytics dimensional data model, and corresponding regulatory data governance framework. Donna is a seasoned Life Sciences Strategist/Business Architect and an expert in Regulatory Information Management with 25 years of experience guiding organizations toward improved business performance by leading the development and deployment of new strategies, processes, and enabling technologies. She has global experience in the pharmaceutical, technology development, and consulting industries.

Ron Fitzmartin is a Principal Consultant at Decision Analytics. Previously, Ron was Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provided policy and strategy consultation on electronic regulatory submissions and standardized data. Ron served as Rapporteur for the ICH M11 Expert Working Group and as Co-chair of the Global IDMP Working Group. Prior to FDA, Ron held several leadership positions in industry: VP, Biostatistics and Data Management and VP, Informatics at Daiichi Medical Research and Daiichi Sankyo, respectively. Ron received his PhD in Statistics from the University of Maryland, College Park.

David Isom is Senior Director, Global Regulatory Policy at Pfizer where he leads policy and advocacy for priorities that include innovative use of technology and data to transform regulatory submission and review, and global regulator collaboration. Before his focus on policy, David led several Pfizer regulatory information management, real world data, and clinical trial data services. Prior to joining Pfizer in 1999, David served at the U.S. FDA as a regulatory project manager in CDER’s Division of Antiviral Drug Products, and later as Head of CDER’s Office of IT and e-submission programs. Before FDA, David worked in healthcare outpatient and surgical settings as a U.S. Navy Hospital Corpsman. David has a B.Sc from University of Maryland.

John Jones is the Founder and CEO of Entitech Solutions, a system integrator focused on developing innovative technology solutions for unmet business needs in Life Sciences. John has more than 25 years experience in developing and delivering IT Solutions for various companies, and has extensive experience in the clinical, regulatory, and commercial areas. His technical specialties include: enterprise architecture planning and definition, long-term technology strategy development, knowledge and content management, information architecture and metadata definition, structured component authoring and data integration/business intelligence platform implementation

J. Paul Kirwan is a Senior Manager, Regulatory Affairs, with Amgen. He currently leads reliance activities associated with cloud-based regulatory submissions and manages the initial filing content for module 3 authoring in collaboration with RA CMC and Process Development. Paul has been a member of the advocacy and external engagement team with Amgen and is active with ISPE, IQ Consortium, CASSS, and BioPhorum. He previously served as a Global CMC Regulatory Lead and is also a former FDA product quality reviewer (CDER, Office of Biotechnology Products) and FDA Commissioner’s Fellow. Paul holds a PhD in Biochemistry from the University of Colorado Anschutz Medical Campus.

Brian is a leader in KPMG’s Life Sciences Consulting practice, with a focus on Regulatory Affairs. He has extensive experience helping clients improve efficiency and enable compliance by implementing process and technology changes. His experience includes leading programs related to global RIM deployments, RA operating model and process redesign, data cleansing/harmonization and adoption of emerging digital technologies.