Michiel has 15 years of experience in Regulatory Affairs and Information Management. He provides strategic direction and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions. His focus goes beyond compliance, Michiel specializes in unlocking the true value of an organization’s data – whilst taking advantage of initiatives such as XEVMPD, IDMP and SPOR. Through the alignment of people, cross-functional processes, and tools, he has enabled efficient and sustainable data quality for a wide range of customers.

Clinical Research/Clinical Management Professional with 24 years diversified experience across functional areas and global regions with current focus in Clinical Operations Risk-based Quality Management business process improvement and eClinical Systems deployment. Career includes greater than 9 years specializing in process reengineering and eClinical system implementation for a large global CRO and 6 years helping companies deploy solutions to streamline processes, improve productivity and operational efficiency, and better manage information across CTMS, eTMF, Risk-Based Quality Management (RBQM), Investigator Portal, CRO Engagement and Clinical Architecture.

Stacy Tegan is a Program Director at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development process. She has expertise in Regulatory Operations, Clinical Development processes, and Project Management gain through 20+ years of experience working for sponsor, consulting, technology, and nonprofit organizations in the pharmaceutical industry.

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics Architect, including Data Management, Analytics and Business Intelligence, Electronic Submission and Portal Collaboration programs. Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.

Jake Doran is currently the Head of Digital @ MAPS Public Benefit Corporation. In this role, Jake is responsible for overseeing the development and implementation of the digital and IT strategy as the MPBC organization transitions from a clinical research startup to a commercial entity and industry pioneer. Prior to joining MPBC, Jake was the Head of Global R&D IT at Bausch Health. Jake prides himself in being a biologist by study and a technologist by trade and throughout his career has positioned himself at the intersection of science and technology. Earlier in his career, Jake held positions of increasing responsibility at Genpact, Janssen Pharmaceuticals and Schering Plough.

An established Regulatory Information Management expert with extensive skills and experience in life sciences. As the VP and GM of Enterprise Technology at Calyx Jo is responsible for the Commercial and SME functions. Our expert team are responsible for strategic consultancy and delivery of services and solutions to facilitate our clients’ business using the Calyx RIM, Calyx CTMS and Calyx EDC technologies. With a remit to ensure that the our suite of technologies aligns with the changing regulatory landscape and client needs and to provide strategic regulatory input into the software development lifecycle, Jo is responsible for the overall budget to align with Calyx fiscal requirements.

Vahé has over 20 years of global regulatory operations, project management and regulatory technology experience, with special focus on regulatory information management, data governance, business process optimization, regulatory intelligence, medical imaging, publishing and global submissions strategy. Vahé has had various leading roles at Alexion, Takeda, Dyax, Millennium, Parexel, and Datafarm, and has also been involved in consulting activities. He is currently heading the Global Regulatory Operation at Apellis. Vahé is an active member of the DIA-RIMWG sub-team on RIM Reference Model.

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.

Cary Smithson is the Senior Director, Business Transformation and Systems Management at PharmaLex and has over 30 years of experience helping life science Regulatory, Clinical and Quality organizations drive increased productivity, streamline information management and enhance regulatory compliance. Her areas of expertise include regulated content and information management, regulatory information management, eTMF, GxP quality / compliance, IT strategy, business process optimization, Agile and project / program management. Cary co-leads the DIA RIM Working Group, leads the DIA RIM Intelligent Automation Topic Team, contributes to the RIM and EDM Reference Models and led the development of the DIA GMP Quality Systems Reference Model.

Katherine Novak provides experience as a Business Analyst across the full drug product lifecycle, including Clinical Research, Regulatory Operations, Regulatory Information Management, Pharmacovigilance, and large-scale Manufacturing. She obtained her MS degree from Georgetown University in Clinical and Translational Research, where she focused on large-scale meta-analyses as a basis for clinical trials. With over four years of experience in the life science industry, Katherine supports clients in system implementation, process development, and data quality. Her passion is in data standard harmonization, specifically Regulatory data and optimization for Regulatory decision-making.

Alison is Sr. Director, Regulatory Affairs Submissions at AbbVie Inc. She has many years of experience in all aspects of regulatory operations including global submissions management and publishing, data and document management systems, quality assurance, regulatory information management and system support.

Joanne Malia is Director, Development Records Management at Regeneron Pharmaceuticals and responsible for the TMF group and Clinical Archives and is the Business Process Owner for the eTMF. Throughout her 25+ year career in life sciences she has worked for diagnostic, biotech, pharmaceutical companies and CROs. She serves on the CDISC TMF Reference Model Steering Committee, on the organizing committee for DIA’s Regulatory Information Document Submission Meeting and presents frequently at industry conferences.

Mr. O’Keefe has over 18 years of R&D management and IT consulting expertise, working with both top tier pharmaceutical firms, and early stage biotechs. Prior to joining Astrix, he led Business & Technology Consulting at Just in Time GCP; he established and led the R&D Consulting Solutions practice for Paragon Solutions/CGI Life Sciences, where he focused on helping drive adoption of business capabilities such as: submissions management and archiving; IDMP; electronic management of Trial Master Files and investigator interactions; and defining and implementing risk-based monitoring programs. He has over 20 years of business and IT consulting experience, with the past 15 years focused in life sciences clinical and R&D.

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our reports into WordPerfect format for the FDA reviewer?" -- and he didn't say "no." Since then, he's been involved with content management, custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard both as a vendor/consultant and within biopharma companies.

Sandy Krogulski is an experienced and solution oriented individual with over 10 years of submission 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.

Rob is a seasoned Regulatory Affairs Operations professional with over 30 years of experience. He was an early planner and adopter for the electronic Common Technical Document (eCTD), previously serving on Bio and PhRMA working groups for eCTD and electronic submissions. Rob has served as a leader of dynamic Regulatory Operations teams of all sizes, including past roles at Janssen, Millennium, Sunovion, and Alexion. His submission expertise includes global investigational and marketing applications. Rob has a demonstrated ability to drive and deliver operational strategies and an in-depth understanding of all facets of Regulatory Operations, including publishing, submission management, document management, and regulatory systems and tools.

Dan Offringa has regulatory career spanning over thirty years. For the past 20+ years he has worked in the electronic submissions field for both the FDA and industry, including guidance promulgation, standards and process development, and system implementation. He is the owner of eSub Solutions, an electronic publishing consultancy, and has been responsible for thousands of submissions to multiple regulatory authorities. Dan holds a bachelor of science degree from Duke University.

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 13 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

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.

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on the standardized clinical protocol template, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme. Ron received a PhD in statistics from the University of Maryland and MBA from University of New Haven.

V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience. Prior to Orion, Bala was the President and CEO of Cabeus, a niche Life Sciences services firm where he was also responsible for vision and strategy for a cloud platform called ReALM® to transform the regulatory value chain for Life Sciences. Bala developed IT strategies and capabilities for Bristol-Myers Squibb, Roche, Aventis, Merrill Lynch, AT&T, Bell Atlantic and IBM. Bala has his PhD and MBA from Rutgers University and MS in Computer Science from NJIT.

Mark has over 30 years’ experience in Information Technology & Management. Mark began his career developing commercial applications and has been working for FDA for over 30 years. Mark’s FDA responsibilities have included software development and project management in CBER; Director of Applications Development & Services in CDER; PDUFA IT Program Director; Director, Division of Data Management Services & Solutions managing CDER’s electronic submission program, and ICH M8 (eCTD) Rapporteur. Mark has been with CBER's data standards group since 2014, and his current responsibilities include representing CBER in the development and implementation of international electronic submission standards.

Jan Benedictus is founder and managing director of Fonto - a user-friendly authoring tool for structured content. Fonto is widely used in content-intense industries such as Publishing, Aviation, Technical Documentation, and increasingly in Pharma and Life Sciences. Jan is actively involved in programmes that are rolling out structured content management and authoring at various top 10 Pharma companies. He will be sharing his experiences on use-cases and key challenges that arise when implementing structured content.

Mr. Chen is a project management Officer at Office of Strategic Programs, CDER, US Food and Drug Administration, where he is responsible for the development and implementation of electronic data standards for CDER regulatory review. As an FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he has been actively participating in the development of E2B (R3) Implementation guide, ISO/HL7 ICSR message standard, and the ISO IDMP standards. TJ has more than 30 years of experience in program management and various data standards and message standards areas. He worked for a pharmaceutical company before join FDA in 2005.

Scott Cleve is currently the Vice president of Regulatory Operations and Compliance at bluebird bio where he leads a team responsible for building and executing publishing, project management, RIM, and compliance activities to support the regulatory organization. In his career he previously led Regulatory Operations teams at Boehringer Ingelheim, AbbVie and Astellas. Scott’s focus is on developing his team, investigating technology to improve process and compliance, and partnering within industry and vendors to improve standards, process and technology.

Dan is a Leadership professional with 20+ years experience in Regulatory Submission production. A subject matter expert for eCTD & EDMS solutions. A business process analyst for submission assembly and eCTD publishing. He’s been a key member of several industry/agency initiatives for electronic submission standardization & efficiency. Dan has presented or chaired sessions at DIA Annual Meeting & DIA RSIDM/EDM Conferences. He's a DIA RSIDM Conference Program committee member. Dan established/directed eCTD publishing groups at Merck & Co., Inc. & Datafarm Inc. (leading eCTD software & services provider). At Teva, Dan led a initiative to harmonize the publishing environment into a single tool set (EDMS, eCTD Publishing etc.).

Joanne Roza works as a Senior Regulatory Affairs Consultant at Qdossier. She is involved in regulatory affairs consultancy and has also expertise in regulatory operations for big- and small-sized pharmaceutical companies. Joanne holds a bachelor degree in Health Sciences from Maastricht University and a master degree in Health Economics, Policy and Law from the Erasmus University in Rotterdam. She started her career at Qdossier in 2016 and has experience in regulatory operations and affairs projects. Joanne’s areas of expertise are: regulatory affairs (strategy and planning), preparation/creation and dispatch of electronic submission formats (e.g. US FDA, CA, EMA, CH), lean/structured authoring and the creation of baseline submissions.

Robert Baldry leads Genpact's Data and RIM migration practice focused on projects to improve regulatory data management through better technology, process and governance. Robert has over 15 years of experience implementing new technologies to the pharmaceutical industry. Projects include xEVMPD and IDMP migration projects. Enterprise wide multi-source legacy RIM to cloud based RIM system implmentations. Global data remediation and migration programs as well as paper to digital transformation projects. Robert studied business and technology at the University of Wolverhampton, United Kingdom and InHolland University of Applied Sciences, the Netherlands

Paul Cutajar has over 22 years of experience in the pharmaceutical industry including 17 years in IT supporting such varied areas as customer contract pricing, sales and CRM, customer master data, and the globalization of the Merck Manuals website. With his most recent focus in regulatory and safety, Paul now serves as business owner of BDLM used to manage business regulatory and pharmacovigilance commitments for partners and vendors. He also supports other regulatory and safety teams' processes and systems, such as Policy Management. Paul has a master's degree in Modern British Literature from Fordham University.

Paul Fenton holds a degree in management from London Metropolitan University as well as an MBA in Technology Management from the Université du Québec à Montréal. Paul has significant industry experience at a senior management level in the development, deployment and management of computerized systems for use in regulated clinical trials. He co-founded Montrium in 2005. He has worked on major clinical technology projects both in Europe and North America and has a strong background in CDISC and ICH standards as well as in the integration of systems and processes for clinical trials. He is a member of the TMF Reference Model Steering Committee and co-chair of the eTMF Exchange Mechanism Standard.

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.

Currently the VP of Life Sciences and Product Owner at DocShifter, Paul has over 20 years of experience in helping to provide regulatory software and service solutions to Life Sciences organisations globally. Paul has practical industry and commercial experience in delivering content authoring & rendering, Regulatory Information Management, submission and report-level publishing, and electronic Document Management solutions.

Rafail is a Senior Data Strategy and Governance Consultant supporting companies of the Lifesciences and Healthcare sector on their transformation to a data-driven organization. With his broad expertise in various functions, he has a holistic approach putting data in the center of processes, technology, and people.

Mr. Kivlehan has been immersed in software product development and consulting services for nearly 26 years. He earned a B.S. in Computer Engineering from Lehigh University and his focus is on drawing insight from enterprise content. For over 10 years he was a self-employed entrepreneur. His work included customization of Documentum, Sharepoint, imaging systems, mobile development and more. He has worked with customers in the Life Science, Insurance, Financial, Packaging, Automotive, Petrochemical, Legal and Real Estate industries. In 2017 Mr. Kivlehan joined Docxonomy, helping to build its core text and content processing engine and is now Docxonomy's Chief Data Officer.

Shannon Laforce joined Health Canada in 2018 as the Executive Director, Transformation and Business Informatics within the Health Products and Food Branch. In her role she is responsible for providing leadership as it related to the development and management of the Branch’s IT modernization and Regulatory Transparency agenda. Shannon has demonstrated strengths and success in leading strategic business initiatives that encompass process re engineering and automation, data standardization and Regulatory Transparency.

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.

Neel Patel is a Principal Consultant at Red Nucleus with many years of experience in spearheading digital transformation initiatives within the Life Science industry. As a strategic, operations, and advisory consultant, Neel excels in digital innovation, technology transformation, business process optimization and software product development, showcasing a results-oriented approach and a track record of successfully executing complex business and technology programs. Neel is recognized for building and leading high-performing teams and cultivating key customer relationships across Clinical, Pharmacovigilance, Regulatory, and IT functions in pharmaceutical organizations.

Andrew Potter is a mathematical statistician in the Division of Biometrics I at the Center for Drug Evaluation and Research of the US Food and Drug Administration, supporting the review work in the Division of Psychiatry. He also leads digital health technology initiatives in the Office of Biostatistics at CDER. His research interests include the use of digital health technologies in clinical trials and the analysis of high-frequency outcome data. He is involved in FDA working groups on this topic.

Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech, med device, high tech, financial services, and manufacturing. Regina is an industry expert in structured content authoring, component content management, and content reuse and automation. She lives a dogspotting lifestyle.

Catalina Rojas is a Doctor in Pharmacy with 17 years’ experience in International Regulatory Affairs (global and affiliate roles). Before she has worked in quality control and assurance activities in manufacturing plants. She's passionate about building highly-motivated teams and building successful, long-lasting connections with diverse stakeholders. Catalina is currently the Regulatory co-lead for automation and is a core team member of a portfolio of initiatives looking at speeding up the regulatory approvals and information lifecycle through technology and infrastructure improvement.

Matthias works as a Senior Data Management Specialist for Qdossier, a Celegence company. 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/DADI). 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. Additionally, Matthias has experience in software development and validation in a highly regulated environment.

Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in many of the Center’s strategic initiatives including decision support, data standards, program analysis, IT, informatics and governance. Ms. Slack serves on several Boards and Committees where she supports FDA’s needs and perspectives.

Frits Stulp is Managing Director of Iperion a Deloitte business, with over 20 years of industry and consultancy experience. In this role he leads a team of regulatory / IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. Frits is the IDMP topic group lead for the IRISS Forum and heavily involved in the EU-SRS project for the Medicines Evaluation Board / European Medicines Agency as part of SPOR landscape. Frits is also Chariman of the Board of CTADHL, involved in Transatlantic adoption of IDMP (www.ctadhl.org). Regarded as an SME on IDMP, he gladly shares his gained knowledge and experience in various occasions around the globe.

Margo Tyler-McWilliams is Associate Director, Global Regulatory Operations Informatics and Analytics at Takeda. She has 19+ years of experience in life sciences and 10 years within Regulatory. Margo has experience across all stages of drug development with expertise in Clinical Development, EU CTR, Global Submission Management, Regulatory Information Management, Compliance, Data Governance, Pharmacovigilance, xEVMPD, IDMP and Automation. Her interests are in interoperable data, process optimization and automation.

Geert Van Peteghem is above all a proud father of 3 children and 2 dogs. He is a full-time optimist and loves his e-bike, Thai food and his wife. Not necessarily in that order. In 2014 he founded DocShifter to help solve document conversion challenges in regulated enterprises. Before that, he managed a number of large IT companies in Northern Europe.

Sholeh is an internationally known TMF Subject Matter Expert with over 15 successful years of experience in the Clinical Research Industry. Her experience includes the TMF Reference Model Subject Matter Expert, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations, electronic document management, regulatory submissions, quality control processes and implementation and regulatory inspection preparation and participation. She is currently Principal Consultant and President and CEO of LMK Clinical Research. She is also the Facilitator for the Metrics Champion Consortium's (MCC) TMF initiative.

Michael joined NNIT in 2021 and is managing the US clinical consultants at NNIT. Michael works with clients to improve their clinical operations compliance and operational efficiency. He is working to increase the agility and automation of clinical processes with several clients. Michael has worked at CGI, Paragon Solutions and Sanofi-Aventis prior to joining NNIT. He has experience in Clinical Operations, Data Management, and Clinical Supply Operations. Michael has a Masters in Leadership Development and a BS in Pharmacy.

Steve is Head of IDMP at J&J Consumer Health and is leading a cross-functional team for digital transformation to deliver IDMP compliance. He has 27 years’ R&D experience with J&J spanning product development and Regulatory Affairs leading multiple global projects across different categories including medicinal products, medical devices, engineered and formulated products. He has worked in Germany, USA and UK. Steve’s interests include delivering new solutions, data and technology strategy, working across functional areas.

Rachel Bombara is a Regulatory Services Manager at Certara with 12+ years of experience in Regulatory Operations and helping clients achieve their submission goals. She has managed the submissions 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 regulatory operations.

Jason Cober is the Lead Project Manager in the FDA's Office of Prescription Drug Promotion. He leads OPDP's eCTD outreach efforts and has 15 years experience with the Agency's eCTD specification and guidance development process.

Lina Cong has medical and computer science background with over ten years of experience on study data standards and study data submissions in FDA. She also has ten years of experience on clinical trial data analysis and clinical data management within the pharmaceutical industry. 

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.

Michel Denarié is part of IQVIA’s Strategic Drug Development team, a group that helps emerging biopharma companies around the world in their early clinical development and regulatory process with target product profiles, clinical development plans, indication prioritization, and regulatory interactions. With 35 years of pharma industry experience, his area of expertise covers all the legacy IMS data assets that can be leveraged world-wide to support clinical development. Denarié earned an MBA from the Colgate Darden Graduate School of Business Administration at the University of Virginia.

Frank Dickert started with an apprenticeship in the pharmaceutical industry and afterwards studied biochemistry with a focus on bioinformatics and structural biochemistry. In 2011 he took an opportunity as a Regulatory Affairs Specialist at a pharmaceutical company and was responsible for centralized, DCP/MRP and national procedures. In 2017 Frank joined EXTEDO’s Regulatory Competence Center and since then, he is consulting pharmaceutical companies in regulatory business and eCTD submissions and IDMP worldwide. Furthermore, he is analyzing and optimizing regulatory business processes and document lifecycles with or without software, resolving customer support issues with different eSubmission tools, and offers regulatory consulting with

16 years regulatory experience within the pharmaceutical industry including 4+ years in a consultancy environment. Regulatory Submissions/Project Management support for pre-approval and post-marketing submissions worldwide. Extensive eCTD submission experience, working with templates and troubleshooting document issues, ensuring proper eCTD structure and life cycling within the needed timelines. Experience in creating SOPs, lean initiatives, regulatory and/or publishing product system improvements. Cross-functional collaboration and facilitation of submission planning activities working closely with CMC, clinical, non-clinical, medical writing, PV, commercial, regulatory affairs and regulatory operations teams.

Leslie Kitchen is a Senior Director in the Regulatory Innovation & Information Management organization at Merck. She joined Merck in 2007 after a successful career as a cardiac nurse. She served in various roles across Safety and Regulatory Affairs including Global Safety Operations, Process and Portfolio Management, and Business Development, Sourcing, and Alliance Management. In her current role at Merck, she leads a Regulatory Information & Communication Management group focusing on developing and supporting innovative digital solutions to manage information across Global Regulatory Affairs. Leslie is also pursuing a Master's degree in Information Technology Management through Georgetown University.

Teresa joined Bayer in August 2009 and has held increasing levels of responsibility in Submission Management. Currently, as Senior Director, Teresa drives strategic technology initiatives, compliance and submission activities for the US region while operating within a global network. She began her career at Interleaf, Inc. building and supporting electronic document management and publishing systems. This experience developed into further opportunities to hold publishing responsibilities within Wyeth Consumer Health, Johnson & Johnson, Schering-Plough and other companies. Teresa brings over 30 years of publishing experience and has a Bachelor of Science in Computer Science from Muskingum University with specialization in Math and Chemistry.

Matt Neal is an author and frequent keynote speaker. He joined Atara Biotherapeutics in 2019 as the Head of Regulatory Operations. Prior to that, Matt was the Head of Product Management for the InSight Suite of Regulatory Information Management Solutions at Parexel, Inc. and partnered with Microsoft. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. (2003-2016) and was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline (1996-2003). Matt has been publishing and submitting electronic dossiers to the FDA since 1996, and submitted the very first fully electronic NDA for GSK in 1999.

Heiner Oberkampf is the CEO and Co-founder of ACCURIDS, which is a software for collaborative data standards implementation, that helps pharma companies, e.g., in the implementation of IDMP standards through a federated product data graph. With a group of pharma companies, he has initiated the IDMP Ontology project under the umbrella of the Pistoia Alliance to promote a universal implementation of the IDMP standards in a collaborative manner in alignment with health regulators.

As the Senior Regulatory Affairs Director for Business & Technology Transformation, Donald works with the Regulatory Affairs and Drug Development Solutions (RADDS) team at IQVIA to add and update technology solutions to RADDS's business processes. His experience bridges the business and technology divide that spans Regulatory submissions, document management, and Regulatory Information Management, especially as they integrate with other departments and systems. Having worked in several organizations of different sizes, he provides perspectives from sponsors, vendors and now CROs. He is a strong proponent of standards and data governance.

Ms. Powell is the President of Powell Regulatory Services. Sarah has 30+ years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 23 years as a consultant, she has assisted clients with projects related to regulatory process improvements, standards development, defining filing strategies and writing/review of submission content. She has extensive experience with projects related to design and implementation of regulatory solutions including document management, submission planning, publishing, and registration management. Sarah is a past executive at Chiron, First Consulting Group and Liquent, and PAREXEL

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.

Leonardo Santos is a pharmacist, PhD in Immunology from University of Bahia, Brazil. He is a health regulation specialist from The Brazilian Health Regulatory Agency (ANVISA) since 2014. He worked with the evaluation of Chemistry, Manufacturing, and Controls (CMC) of pharmaceuticals for post-approval changes. After spending almost four years working with health control of pharmaceuticals, medical devices, food, and cosmetics importation in different positions, he is now an assistant in the general Office of Drug Products leading the process of eCTD implementation.

Pat Shafer is a Managing Director at FTI Consulting. He is responsible for delivering services, solutions and thought leadership for pharmaceutical, biotech and medical device clients. He has over 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of regulatory affairs and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. He currently leads the development of the RIM Whitepaper 3.0 as part of the RIM Working Group, and leads the Culture of Quality initiative as part of the FDA/MDIC Case for Quality.

Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

Sadia leads the team responsible for RIM Smart Submission Management at IQVIA. She has over 20 years of experience in IT and Life Sciences Industry working globally for consulting and technology solution companies. Sadia has comprehensive knowledge of global electronic submissions publishing, business process optimization, document management, systems integrations, and regulatory information management.

Gary is an Associate Director responsible for Innovation and Information Management at Merck. His pharmaceutical career spans over 20 years and includes roles as an Information Technology Manager, R&D Operations Lead and Regulatory Affairs Program Manager for the integration of Regulatory content and data obtained through mergers and acquisitions. He is an accomplished business technology professional with extensive experience managing digital platforms and programs in global pharmaceutical environments. He holds a bachelor's degree in Computer Science from Temple University and MS, Information Science and MBA degrees from Penn State University.

Vivian Combs is a full-time Process Owner within Eli Lilly and Company's Clinical Trial Foundations organization, where she is focused on medical writing, content reuse, and automation. She recently completed her duties as the rapporteur for the ICH M11 CESHarP (Clinical Electronic Structured Harmonized Protocol) Expert Working Group, and previously led the TransCelerate workstream responsible for the development of the TransCelerate Clinical Template Suite.

Sheila Elz grew up in Michigan, USA, and now lives in Germany. After a career as concert pianist, she acquired a BSc in Nutritional Science and a MSc in Toxicology, specializing in biochemistry and statistical analysis. Sheila brings the regulatory perspective to her current job as Master Data Manager at Bayer AG Pharmaceutical R&D. Her primary focus is on cross-functional and global master and reference data management. She is co-leading two International Organization for Standardization (ISO) teams of experts in the drafting of guidance for indications terminology harmonization, and on building a logical data model for ISO Identification of Medicinal Products (IDMP) standards, and is co-leading the Pistoia Alliance IDMP Ontology.

Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the future. Prior to joining EMA, from 2011 to 2020, he served as the Director for Business Informatics at the U.S. Food and Drug Administration leading the transformation of medicines regulatory data, advancing data analytics, and modernizing the scientific computational and collaboration platforms that underpin operations.

Kelly is a recognized industry leader in RIM and IDMP with 30 years in the pharma industry, the last 17 focused on Regulatory Affairs. She currently heads K2 Consulting, a specialty firm focused on Regulatory Affairs, has previously held leadership positions in IT and Regulatory Operations/RIM at Wyeth, Pfizer, Shire and Teva. Kelly is part of the Gens & Associates World Class RIM core reasearch team, has been actively involved in the EU implementation of IDMP as a member of the SPOR Task Force and its PMS subteam, and currently the President of IRISS Forum.

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

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.

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.

Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives, including the Pharmaceutical Quality/Chemistry, Manufacturing, and Controls structured data project. He is also serves as a delegate to the International Organization for Standardization's (ISO) Technical Committee (TC 215) on health informatics which deals with the IDMP standards. Currently he is Associate Director in FDA’s Office of Process and Facilities in CDER. He has never served time in prison.

Dr. Olaf Schoepke studied Computing Sciences in Germany and holds a PhD in Computer Architecture from Bath University (UK). He is now the Director of Strategic Development at Samarind Ltd., having worked for PricewaterhouseCoopers, advising pharmaceutical companies worldwide on document and submission management.

Siva has over 25 years of Life Sciences experience with almost 20 years in R&D. At ZS, Siva specialized in digitizing Safety and Regulatory business processes. Siva’s expertise is in understanding the opportunities and challenges the industry faces in the R&D value chain and drive innovation using digital levers such as data sciences, AI / ML, mobility etc. In safety, Siva has experience leading PV operations including ISCR processing, aggregate report authoring, QA function in safety etc. across various pharma companies for service provider organizations.

Sam has 20 years of cross functional, multi-disciplinary experience across Life Science, Healthcare, and Information Technology, focused on the applied use of data technology for clinical, regulatory and safety applications. His specific experience includes the design and implementation of lakes/warehouses, ETL scripting, and implementing regulatory compliant data management solutions. Special experiences/knowledge within: • Identification of Medicinal Products (IDMP) Readiness Assessment and Implementation • Clinical, Safety and RIM Vault implementations • Data Architecture with specific focus on Master data Management, Data Stewardship and Data Governance • SDTM, ADaM, PQ/CMC FHIR, IDMP (ISO) standards.

Adair has 20 years of experience in Regulatory Affairs and has worked for companies such as ImClone Systems and Celgene where she led the planning, review, and delivery of high-quality regulatory submission dossiers in support of the development and registration of anti-cancer compounds worldwide. At PharmaLex Adair leads a team of Regulatory Affairs professionals and is accountable for the overall planning and management of Regulatory Affairs resources to effectively support timely and quality submissions to Health Authorities (i.e., FDA, Canada, etc.). Adair is experienced in defining, assessing, and improving processes and works closely with life sciences companies to plan and manage successful Regulatory projects.

Chris Whalley brings 20 years of experience in biotechnology & healthcare operations and is currently Associate Director of Regulatory Policy & Intelligence at Seagen Inc., a biopharmaceutical company focused on oncology therapies. Prior to joining Seattle Genetics, Chris established & led the global healthcare & life sciences regulatory program at Amazon Web Services, and he previously built regulatory & quality programs at Fred Hutchinson Cancer Research Center, Amgen, and a number of pre-commercial biotech companies in the Seattle area.

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.

After an international career in management consulting and information technology at Software AG and Comshare, Akira Yamaguchi joined LORENZ Life Sciences in 1995. His initial role was software development in the field of electronic submissions, achieved in 2001 with the release of docuBridge as a major company milestone. In 2003, Mr. Yamaguchi became responsible for LORENZ' overall software product development. In his Project SME role, Mr. Yamaguchi advises larger customer implementation projects. His current task is to develop the strategic directions of LORENZ' software portfolio.

*Chris Joneckis currently serves as the and the Office Director For the Office of Regulatory Operations and Associate Director for Review Management in the Center For Biologics Evaluation and Research (CBER) at FDA. In this capacity, he Is the Center’s authoritative expert on review management, directing the review management staff and providing leadership for review program activities for biologics, devices and combination products executed throughout the offices of CBER. He is responsible for the development, implementation and oversight of several CBER programs including policies, procedures and standards for review, data standards, information technology, regulatory affairs, document control, regulatory database and regulatory business

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.

Donna Yosua leads the Merck Data Harmonization & Interoperability project which includes the implementation of a regulatory data hub and canonical data model with reusable data publications, and the 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.

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.

Ray Wang leads the Data Standards Staff within CDER’s Office of Strategic Programs. He is responsible for managing a portfolio of initiatives that covers the program areas of Study Data, Product Quality Data, Postmarket Data, Real-World Data, and data standards-related policy activities with the goal of driving greater consistency and efficiency in submissions for regulatory review. Mr. Wang has a M.S in Technology Management, and an MBA from University of Maryland.