Jillian Carinci is Sr. Director, Head of Submission Sciences group at Biogen. Jillian leads Biogen’s Global Delivery Managers and is responsible for overseeing global submissions, establishing processes, ensuring compliance, robust submission planning, tracking metrics, high quality submission delivery and process improvements. Jillian began her career at Octagon Research Solutions before transitioning to Accenture. During her tenure at Accenture Jillian partnered with sponsors to manage numerous regulatory submission projects, ensuring compliance with global regulatory requirements, delivering within scope, on time, and with the highest quality.

Maria Barhams Sagoua joined Accumulus Synergy as Director, Regulatory Innovation where she is responsible for translating regulatory requirements into practice within the Accumulus Platform. Prior to joining the Accumulus team, Maria served as SAS’ Principal Consultant to the U.S. FDA where she was responsible for partnering with the Agency to advance digital transformation goals across regulated products.Throughout her career, Maria has worked across the biomedical research (NIH), regulatory (FDA), technology (DrFirst) and clinical (Kaiser Permanente) ecosystem to support the design, development, and delivery of innovative solutions. Maria holds a BS-Biology from Ball State University and MHSA from the George Washington University.

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.

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 a member of CDER’s Division of Data Management Services and Solutions, with a focus on eCTD and has been with FDA for 15 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 35 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 Industry Solutions Group 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 14 years, most recently as the DIA RIM Working Group subteam lead for the RIM Reference Model.

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

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.

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.

Rachel has 13+ 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.

Regulatory Affairs Business Solution expert with proven industry experience in project management, advisory services, business analysis and business support of the Department. With her 10 years’ experience at AstraZeneca leading Regulatory IT projects, spanning business/technology analysis, project management, validation/testing, business training development and delivery she has credibility speaking with both IT and Regulatory business stakeholders. As an end-to-end RIM process data and system expert with 9 years’ experience in Regulatory consulting for top pharma clients she has led business process optimization, RFP and vendor selection, implementation, and migration projects.

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.

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 the Director of Regulatory Solutions 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, business and her global experience with various pharmaceutical clients.

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.

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.

Matthias works as a Senior Consultant at Main5 GmbH & Co. KGaA. The focus of his work is Data Management, where he provides consultancy and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions and compliance projects (e.g. IDMP). In these projects, he is looking to gain more for the client than just compliance, by engaging people, processes, and tools, he is working to improve the client's data quality and processes. Additionally, Matthias has experience in software development and validation in a highly regulated environment.

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.

Cindy Chiu is a Senior Director in Global Regulatory Affairs and Clinical Safety group at Merck & Co. She has over 20 years of experience in the pharmaceutical and energy industries, focusing on post-merger process integration and operations excellence. She has served in various leadership roles overseeing project management, business process improvement and change management initiatives. In her current role at Merck & Co., she is the Lead of the Regulatory Content Authoring and Archiving Management group. Prior to Merck, she worked as a management consultant, where she assisted clients with change management and business process redesign as a result of merger activity or technology integrations.

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.

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.

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.

Mr. Senay is a visionary leader with a focus on innovation and positive change. At the heart of his mission is the widespread adoption of cutting-edge Informatics solutions, aimed at ensuring the availability of safe, effective, and new medicines for patients. As a U.S Excellence in Government Leadership Fellow, Mr. Senay is recognized for his excellence in delivering impactful results. Holding a master's degree from The Johns Hopkins University and being a Certified Program Manager, he brings extensive knowledge and expertise to advance the FDA CDER mission.

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical method development scientist, and a manufacturing specialist. He was also licensed by the New York State Board of Pharmacy to release compounded products to the market. Ciby holds a Ph.D. in chemistry from Johns Hopkins University, Master’s degree in chemistry from St. John’s University, and a Bachelor’s degree in chemistry from Binghamton University.

Jennifer Carlino is a Senior Director of Regulatory Information Submission Management at Bristol-Myers Squibb, with 25+ years in the pharmaceutical industry. She leads global eCTD submissions, guiding teams through complex regulatory requirements in the US and beyond. Jennifer holds a Master’s in QA/RA from Temple University and is committed to advancements in submission strategy and regulatory science through operational excellence and innovation.

Chris Dowdall is a Principal Data Sciences Product Leader at Roche, where he drives enterprise efficiency through transformative data, content, and AI initiatives. With over 15 years of experience, Chris is an expert in analysis, lineage, modelling methodologies, and implementation of content and data governance frameworks. Chris is the lead architect of the Roche Content Model (RCM), a semantic framework for enterprise content management. The RCM provides a unified content modelling language that ensures interoperability and powers data-driven automation across distributed application ecosystems.

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.

Niklas Jänich serves as the Head of Global Labeling Operations & Digitization at Boehringer Ingelheim. In this role, he oversees the end-to-end labeling process, ensuring system efficiency, regulatory compliance, and driving digital transformation. His key focus areas include advancing structured content management within the GxP-regulated labeling framework and championing the global rollout of electronic Product Information. Niklas is a licensed pharmacist with a PhD in medicinal chemistry and a Master’s degree in Drug Regulatory Affairs, combining scientific expertise with regulatory insight to shape the future of pharmaceutical labeling.

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 is focusing on digitalization and automation of processes to improve submission strategy and business operations.

Anjana is a passionate advocate for patient empowerment. With over 20 years of experience in the Pharmaceutical and Global Health Authority sector, she possesses strategic insights into the medicinal product journey, from development to patient care. As the Director of Product Strategy at EXTEDO, Anjana has a strong track record of successfully launching software products into the market. Her role involves actively listening to industry challenges, identifying areas for innovation, and spearheading transformative initiatives within the global network. Anjana’s expertise extends beyond the present; she scans the horizon for future changes that could impact our work today.

John is a skilled and versatile life science professional with 5 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.

Kristiina joined the European Medicines Agency in January 2002 and is responsible for the implementation, coordination and maintenance of the eSubmission systems and processes at the agency. Kristiina is a Product Owner and a subject matter expert for eCTD v3.2.2, eCDT v4.0, the electronic Application Forms (eAFs), the eSubmission Gateway and Web Client, the Common Repository, the PSUR Repository and the business processes related to the eSubmissions. Kristiina works closely with the EMA business and technical colleagues and the development teams, the colleagues from the European Medicines Network (EMRN) and pharmaceutical industry. Kristiina represents the EMA in eSubmissions related stakeholder groups and is a co-chair of the ICH M8.

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.

Sigrid Selberg is the Chief Scientific Officer at Chemestmed, a role she has held for nearly two years. She is responsible for leading the company’s GLP toxicity studies, coordinating IND preparation, and managing international collaborations with CROs and academic partners to further develop Chemestmed’s comprehensive epitranscriptomic pipeline. Dr. Selberg holds a Ph.D. in Analytical and Physical Chemistry, with her doctoral research focusing on organic synthesis and acidity studies in biphasic, cell membrane–like systems. Her multidisciplinary background bridges chemistry and biomedical innovation, supporting Chemestmed’s mission to translate cutting-edge science into safe and effective therapeutic solutions.

Magnus Wallberg completed his M.Sc. degree in Engineering Physics from Uppsala University, School of Engineering. Since 1999 Magnus has worked in the area of pharmacovigilance informatics. Magnus has for many years had the overall responsibility for the Systems Development Strategies of internal and external development projects at the Uppsala Monitoring Centre. Magnus now has the role of Technology Evangelist focusing on harmonization and beter use of technology to enhance patient safety.

Andrea Bastek, Ph.D., is VP of Market Strategy at Florence Healthcare. Her team works to drive transformation in the eClinical industry in order to improve the site experience and the collaboration between sites and Sponsors/CROs. Prior to Florence she spent 15 years supporting sites running cardiac medical device studies working with and leading a unique sponsor field team. She holds a Ph.D. in Bioengineering from The Georgia Institute of Technology as well as a BS and MS in Biomedical Engineering from Tulane University.

Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that enable organisations to generate value from data. In their current role, Vanni is the Regulatory Data Lead at Roche and is based in South San Francisco.

Jason Cober is the Director - Regulatory Review, AI, and Digital Transformation at ProPharma Group. He previously led FDA/OPDP's eCTD implementation and has 17 years' experience with the Agency's eCTD specification and guidance development process.

Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products. Her work at various pharmaceutical and biotech companies includes digital innovation, process management, and preparation of marketing applications for Health Authorities.

Sharon Kim, PharmD, is CEO and founder of MPilot, an AI company transforming how clinical and regulatory documents are designed, authored, and reviewed. With extensive experience at Pfizer, Genentech, and Gilead, she founded MPilot to make AI a true collaborator for medical writers, enhancing accuracy, consistency, and compliance while preserving human oversight. A recognized advocate for ethical and practical AI adoption, Sharon has led sessions at DIA, AMWA, and in academia, advancing industry understanding of how AI can improve regulatory workflows, accelerate research, and strengthen confidence in data integrity across the life sciences.

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, University of Southern California, and the University of Maryland.

Regulatory Labeling professional with 20 years experience in Biotech and Pharma. Skilled PM having led multiple cross-functional and cross-cultural teams. Currently responsible for leading US, EU, Japan, and China Labeling activities for five global products. Led an internal initiative to develop and implement a standard global process for implementation of Electronic Labeling (e-Labeling) at Astellas Pharma Inc. Additionally, skilled automation and validation engineer having designed and built multiple automated systems, including GxP validation where applicable, which drive efficiency in global processes.

A self-motivated, committed, and diligent individual with leadership experience in regulatory product management and initiative management. I am keen on learning and help transform regulatory information landscape.

Mukesh Singhal is a leader in Deloitte’s R&D and Regulatory practices, with over 15 years of industry experience shaping and leading digital transformations across the industry. Mukesh has led a cross-industry Regulatory Intelligence forum since 2018, helping to shape an industry vision for a next gen regulatory intelligence capability. Mukesh is the product owner of Deloitte’s next gen regulatory intelligence industry solution.

Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology. Her areas of expertise include regulatory information management, artificial intelligence, data strategy/governance, clinical/R&D and GxP content management, IT strategy, enterprise architecture, Agile, business process optimization, and project/program/portfolio management. Cary co-leads the DIA RIM Working Group, leads the DIA RIM Intelligent Automation Topic Team, co-leads the RAPS AI Community, and regularly serves as an industry thought leader.

Kathleen has spent over 25 years in the life sciences digital content space as an editor, product manger, Editor in Chief, and leader of integrated content teams. Over her career, Kathleen has led teams to embrace new ways of working supported by innovative content operations including structured content authoring. Recently, Kathleen has worked with several pharmaceutical regulatory affairs groups as part of their journey to data-integrated, digital solutions.

Angela Dyer brings over 30 years of experience in the biopharma industry. A seasoned Regulatory Affairs leader and executive leadership coach, key roles include Department Head of Regulatory Affairs Cangene Corporation, VP & Global Head of Regulatory Affairs Emergent BioSolutions Inc. and Chair of the Canadian Association of Professionals in Regulatory Affairs (CAPRA). Angela has overseen product licensure and maintenance for 11 products across 30+ countries. Her regulatory technical experience spans across various modalities including anti-toxins, small molecules, vaccines, therapeutics, and combination products. A 2x founder, Angela embraces a 'can-do' mindset and is driven to translate scientific data into drug approvals for patients.

Jamey Galione is a seasoned Regulatory Affairs leader with over 25 years of experience driving excellence in Chemistry, Manufacturing, and Controls (CMC), Regulatory Operations, and Quality Assurance. Jamey’s career spans leadership roles as Global Regulatory Strategist, Global CMC Specialist, and Regulatory Project Manager, with deep expertise in vendor management, eCTD submissions, and regulatory systems optimization. Skilled in implementing and enhancing content management and tracking platforms, Jamey streamlines global operations and ensures compliance. A cancer survivor, Jamey advocates for advancing early detection through biomarkers, diagnostics, and medical devices, reinforcing a lifelong commitment to improving patient outcomes.

Andrea began her career in genetic toxicology before joining the MHRA in 1996. She has worked in diverse roles including product licensing, system development, and various and various business architecture roles. Her responsibilities have included working with International Partnerships on several projects such as IDMP and eSubmissions. For the past three years she has been Deputy Director in the Health Quality and Access Group, managing teams including those handling eCTD. Most recently her work has focussed on aligning business needs with system development.

Kruti is a Senior Consultant at Astrix, where she helps life sciences organizations rethink how regulatory content is created and delivered. Her recent work focuses on implementing AI-powered solutions that not only automate processes but also inspire people to work differently. With a background in project management and organizational change, Kruti believes true transformation happens when technology meets human adaptability.

Calyn Stanfill is a Senior Manager at Gilead Sciences with 12+ years submission experience. She has been a leader in leveraging submission tools to cut rework and streamline the global submission process. With a focus on compliance and collaboration, Calyn has a deep technical expertise and a passion for process innovation to strengthen global team capabilities.

With over 15 years at the intersection of Digital Innovation and Life Sciences, I have spent my career shaping how technology can accelerate drug development, regulatory operations, and commercialization. An IIT alumna and former Novartis professional, I’ve worked across the full value chain of pharma from R&D and Regulatory to Clinical, Safety, and Commercial helping global organizations modernize how they manage data, content, and decisions. Today I lead a rapidly growing AI services startup Slickbit focused exclusively on building custom GenAI and automation solutions for Life Sciences. At Slickbit, our mission is to help pharma and biotech companies translate the promise of AI into practical, compliant and high-impact outcomes.

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.

Murali Menon is Chief Revenue Officer at Docuvera, where he leads business strategy and partnerships focused on transforming how life sciences organizations create, manage, and deliver clinical and regulatory content. With over 20 years of experience in technology and digital transformation, Murali is passionate about helping teams move from document-based to data-driven processes. His leadership combines deep domain expertise with a vision for interoperability, automation, and compliance across the clinical lifecycle.

Keith founded and has led the IT & Life Science Strategy for Court Square since it's inception in 1995. Keith understands the intersection between IT and Quality within the Life Science industry and continues to drive FDA Compliant IT Solutions. Instrumental in creating the Audit Ready Compliant Cloud (ARCC) platform specifically used for qualified and validated applications from pre-clinical to manufacturing with a specialty in Clinical and Regulatory systems. Keith is also co-founder of both RegDocs365, a regulatory content management repository and EmpiraMed, an ePRO, EDC and Registry software solutions company.