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

Lorelle Leonienco, PMP Product Manager, Global Regulatory Agencies, LORENZ Life Sciences Group, Canada With over 20 years in Life Sciences, Lorelle has held roles across Commercial, Regulatory, Medical, Clinical, and IT in both Generic and Brand Pharma. Her career has focused on implementing technology to modernize operations, drive efficiency, and support regulatory compliance. As Product Manager for Global Regulatory Agencies at LORENZ Life Sciences Group, she steers the development of strategic RIM solutions designed to meet the evolving needs of Health Authorities, ensuring they are aligned, user-focused, and impactful across the global regulatory landscape.

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.