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

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.

Peter is the Sr. Director of Publishing & Submissions for Astellas. This global group has responsibility for compiling, dispatching and archiving submissions and ensuring those activities are captured in the appropriate systems. Peter has been involved in multiple global programs targeting process improvements around product change control, document management and submission management. Prior to moving into Regulatory Operations, Peter worked in IT at Astellas focusing on informatics in the areas RA, QA and document management. Peter has a Bachelor’s degree in Mathematics from Austin College in Sherman, TX, and an MBA from the Lake Forest Graduate School of Management.

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.

Thomas is a 20+ year experienced leader in Pharmaceutical, Diagnostic and Medical Device Regulatory Affairs, Electronic Publishing and Document Management. He has a strong track record of successful regulatory interactions and filings, resulting in the approval of over 25 new drugs, devices and diagnostics. He has worked for a number of organizations both in the Consulting and CRO industry, as well as on the sponsor side of the equation. He has developed services and led global teams resulting in the consistent delivery of high-quality output aligned with business needs. Some of Thomas’s skills include regulatory process and workflow excellence, eCTD publishing, document management, commercial regulatory, and computer systems validation.

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.

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.

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.

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.

Danielle Beaulieu, PhD Danielle obtained her PhD in Biochemistry from Laval University Canada. After a 13 years career in Microbiology Drug Discovery, she moved into regulatory operations where she managed several drugs at different stages of development in the US/EU. In 2012, she began managing BMS’s home grown RIM Solution. She also envisioned, helped develop and instituted a Data Quality program. In 2014 BMS began the work to replace their older RIM solution with a new authoritative source for RIM. Danielle was been the Business lead for that effort, from process definition and simplification to configuration and roll out, and she is now the head of the Business Capabilities group for regulatory at BMS.

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.

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.

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.).

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.

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.

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

Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. She is Program Manager for Project PRISM, co-Chair of the FDA Data Standards Advisory Board and FDA Topic Lead for the ICH M2 Electronic Standards EWG. Ginny has worked in informatics at FDA since 2004.

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.

Sarah Powell is the President of Powell regulatory Services. Sarah has over 35 years of experience in pharmaceutical and related regulated industries. Sarah has worked as an independent consultant assisting clients with projects related to process improvements, standards development, and implementation of new technology. While in industry, Sarah performed roles within the Clinical, Quality, Regulatory Affairs and Regulatory Operations groups. Sarah has extensive experience with preparing regulatory submissions for biologic products for submission in the US and EU. She also has detailed knowledge on the requirements for the regulatory information systems.

Dr. Wendy Charles has been involved in clinical trials from every perspective for nearly 30 years with a strong background in operations and compliance of digital health technologies. She currently serves as Chief Scientific Officer for BurstIQ, a health IT company specializing in blockchain and AI. She is also an adjunct faculty member in the Health Administration program at the University of Colorado, Denver and in two departments at the University of Denver. Dr. Charles augments her blockchain healthcare experience by serving on the EU Blockchain Advisory Panel, Government Blockchain Association, and IEEE Standardization Committees. She is certified as an IRB Professional, Clinical Research Professional, and Blockchain Professional.

Ms. Fallen is an authority on the business processes and associated use of information technology in drug development with a focus on regulatory and clinical. A passionate advocate for moving life sciences business on-line, Betsy is an expert on regulatory and clinical operations. Over the two decades of outstanding contributions at Merck, she was recognized for her leadership and excellent representation of the organization on internal transformational teams and in many industry initiatives. Now consulting, she continues to be recognized for her knowledge in technical innovation, process efficiency and ability to assess and assure compliance in documentation, execution and oversight.

As the Chief Data Officer of the FDA, Ram C Iyer has the accountability to develop and execute an agency wide data modernization strategy, building robust central functions that can be leveraged by the centers and the agency for high value decisions. The scope spans the entire stack from data identification to actionable decision, including data policies and governance. Ram is an industry and peer recognized data and technology professional with experience in the Pharma, Consulting, Telecom and International Government organizations. His expertise includes Data and Decision Sciences, Digital and Technology Architecture, and Talent Development with a focus on building collaborative partnerships and Ecosystems.

Venu Mallarapu is a leading industry expert in Life Sciences R&D. In his current role he is working as global market lead for Cognizant Life Sciences R&D technology consulting services. He spent the past 20 years in providing business and technology strategies to transform Clinical, Regulatory Affairs, Safety & PV. He is actively working in helping the industry in adoption of Decentralized Clinical Trails, building technology to drive Digital Medicine, implement platforms to drive end-to-end transformation in Safety & PV and Regulatory Affairs and develop solutions to adopt disruptive technologies like AI, ML, NLP and Blockchain in Life Sciences R&D.

Robin M. Weinick, PhD. brings 25 years of experience to her DIA role as Senior Vice President & Managing Director, Americas, and Global Program Officer.Robin joins DIA from RTI International, a large, nonprofit research institute dedicated to improving the human condition. She also has served as Associate Director for Health at the RAND Corporation, a premier U.S.-based think tank, and on the faculty of Harvard Medical School and Massachusetts General Hospital. She began her career in federal service with the U.S. Department of Health and Human Services. She holds a B.A. in Health and Society from the University of Rochester and a Ph.D. on Population Dynamics from Johns Hopkins University.

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.

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.

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.

Vid Desai is a seasoned technology leader who brings more than 30 years of experience in the information technology (IT) field, with over 26 years in the healthcare and life sciences industries. He has previous experience working for large Pharma, Clinical Research Organizations (CRO) and Medical Device companies. As the FDA Chief Technology Officer (CTO), Vid is the day-to-day operations and technical leader of the Office of Information Management & Technology (OIMT). OIMT is FDA’s Enterprise Technology team that supports all the FDA Centers and Offices for their enterprise technology needs. This team oversees the overall FDA IT spend of over $750M and a staff of around 2,500 employees and contractors.

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.

Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.

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.

Sean Manion, PhD is a neuroscientist with two decades of federal brain research and leadership experience. He is the Chief Scientific Officer of ConsenSys Health, a start-up focused on the application of emerging technology (blockchain, decentralized machine learning, and privacy-preserving encryption) in healthcare and life sciences. He completed his doctoral and post-doctoral work as a civilian at Uniformed Services University of the Health Sciences looking at pre-clinical models of post-traumatic stress disorder (1999-2009). He continued work with the Military Health System as Deputy Chief of Staff and later Research Activities Chief for the Defense and Veterans Brain Injury Center (2009-2017).

Alison has 15 years of experience, including a broad range of strategic and operational activities from development to commercialization. She has been an eCTD publisher at Octagon Research Solutions, a Regulatory Project Manager, a TMF manager at Omnicare Clinical Research, and a Regulatory Affairs Consultant for drug development activities in North America, where her roles included serving as U.S. agent for foreign sponsors and FDA meeting facilitation. Most recently, she designed and oversaw global regulatory outsourcing programs for medium and large pharmaceutical companies. Alison joined Veeva in March 2020 where she serves as the US Director of Strategy for the Veeva Vault Regulatory Information (RIM) product suite.

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.

Marion Mays in an industry leader in Information Management with over 25 years of experience in the Pharmaceutical industry. An advocate for essential information management practices; competent training for all contributors and consumers of the documentation which supports the advancement of clinical outcomes. Highly skilled in developing and implementing enterprise-wide programs and systems in regulated environments with proven record of success in technical problem solving. In-depth experience with quality and compliance processes in the pharmaceutical industry including supporting organizations through major regulatory inspections with FDA, MHRA, EMA, and PMDA.

Dom Moloney is an Associate Director within PRA’s Regulatory Project and Submission Management group. With a background in physics and a passion for electronic systems and collaboration, he has been active in the pharmaceutical industry since 2004 holding a variety of regulatory operations roles, both hands on and managerial. Dom has experience in global regulatory submission management and strategic planning including reference and emerging markets. He has in depth knowledge of local regulations and best practices in electronic and paper submissions. Having been a regulatory publisher in his early days, he is a keen advocate of 'protecting the publisher' from tight timelines and dodgy documents!

Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP. Remco is Chair of Medicines for Europe Telematics group; and President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals.

Jim has nearly 30 years of experience with compliant software solutions for regulated processes in both the insurance and life sciences industries. He has held senior management positions at Intracorp (a CIGNA company), Liquent, Thomson Reuters, ePharmaSolutions, DitaExchange and Cunesoft. Following the merger of Cunesoft into Phlexglobal, Jim is now the Chief Product Officer at Phlexglobal. Phlexglobal is now part of Cencora PharmaLex. Jim holds a Bachelor of Science in Mathematics from The Pennsylvania State University.

Lead for the Labeling Networks at Navitas with over 18 years of varied experience in the Life sciences, Medical Devices and Consumer product sectors. She has experience in the E2E labeling business process and a background in Quality Management and Technology across the Regulatory and Commercial environments. Experience includes: E2E Labeling/artwork process design/improvement, POC, implementation and training Strategy development and thought leadership – Labeling and RIM Quality Management design and implementation Team Leadership – work with teams to ensure projects are delivered on time and budget with a high degree of quality and customer satisfaction Culture and Change Management

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.

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.

Mr. Reynolds has over 30 years of experience as a successful entrepreneur, senior executive, and managing consultant with core competencies focused on enterprise content management, mobility, business process engineering, imaging, and records management. Currently, Mr. Reynolds is the Founder and CEO of Docxonomy. The breadth of his knowledge includes the architectural design and development as well as project management of numerous global, large-scale document/records management initiatives across multiple industries including pharmaceutical, biotechnology, medical devices, financial services, insurance, healthcare, and the public sector.

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.

Sujit Shetty holds a master’s degree in business administration and brings over 10 years of experience in Regulatory Publishing and Submissions. Currently, he is heading the Regulatory Publishing group at Quartesian. Prior to Quartesian, he worked with PPD and Tata Consultancy Services and was responsible for end-to-end publishing and submissions to different health authorities.

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, intelligent automation, data strategy/governance, e-submissions, 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, leads the new RAPS AI Community, and regularly serves as an industry thought leader.

Allison Steffen is currently the RO Submissions Lead at WAYS Pharmaceutical Services. With over 12 years in client services, she is well versed in the compilation and submission of eCTD applications. She has been the project lead on nearly 80 Initial Applications, as well as hundreds of lifecycle sequences for a wide range of products across multiple Global Health Authorities.

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.

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.

Adam Bone has spent over 20 years in the Pharmaceutical industry. He has worked for 4 companies during that time, with the last 13 years being at Merck. He is the Subject Matter Expert for Merck's Outsourced Documents and Vendors. He plays tennis at a high level and loves the Red Sox. Adam has a Bachelor's Degree in Criminal Justice. Hopefully the audience for this Program will enjoy the presentation as much as Adam enjoys winning the crowd over.

Greg Brolund is a management and technology consultant with experience with global pharmaceutical companies’ regulatory information management business processes and supporting technology. He was at the FDA / CDER for over 25 years was the rapporteur of the ICH M2 group leading to the initial eCTD specification. After FDA, Mr. Brolund was the Chief Technology Officer for the US Department of Health and Human Services and has been a pharmaceutical industry consultant for the last 18 years.

Trained bench scientist (Queen’s University, National Institutes of Health) reinvented as a regulatory documentation writer and leader (8 years at Roche) with experience across oncology, pediatric, and rare diseases. Driven to translate science into medicine, increasingly involved with operational excellence initiatives impacting regulatory content management and submission and the design of executable strategies to advance future business needs.

Teresa Eastwood is a Global Team Leader within Pharma Development Regulatory Operations, Roche, and Product Owner for a centralized Automation 'Factory'. With over 15 years’ in Regulatory Affairs, she is known as an expert in drug application requirements and drug development processes. She is an active lecturer at ETH University and forums. A passionate advocate for innovation, Teresa regularly assesses future trends in industry and technology and proactively translates them into opportunities to increase efficiency. After 9 years in Actelion Pharmaceuticals Ltd., building a regulatory operations function from the ground-up, Teresa found her why when joining Roche in 2014 to bring therapies to patients faster while ensuring patient safety.

Extensive industry experience in Regulatory Operations and Regulatory Information Management with proven success in the implementation of Regulatory processes and compliance with regulations. In Karen's current role as Director of Regulatory Information Management at Calyx she leads a team of Regulatory Consultants who provide strategic regulatory input into the software development lifecycle and support clients with their subject matter expertise to effectively manage complex regulatory processes, to align with the changing regulatory landscape.

Ken Keefer, MBA, is founder of Keefer Consulting Inc., dedicated to helping biopharmaceutical companies solve business problems through information technology. He has worked with clients including Pfizer, Merck, and GSK in transforming R&D and commercial business processes. He managed the review of the eTMF Exchange Mechanism Standard (eTMF-EMS), Version 1.0, for the TMF Reference Model Group, an initiative under the auspices of DIA. (eTMF-EMS is a common standard for exchanging trial master file documents between systems.) He holds an MBA from Temple University and a Post-graduate Certificate in Pharmaceutical and Healthcare Business from the University of the Sciences in Philadelphia.

James Kelleher is CEO of Generis, which provides end-to-end solutions for RIM and other Life Science use cases, and has been working in the Life Sciences in content / information management for over 20 years. He is frequently involved in industry group defining standards and best practices for ECM.

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.

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.

Jennie has worked within the industry for over 20 years, with a focus on systems and processes to support the Regulatory Affairs business. She has a wealth of experience including RIM System implementation, Business Process review and improvement, Regulatory Intelligence, Submission Management and electronic Publishing. Jennie's current role at PharmaLex is Director of Regulatory Informatics & Operations, focusing on systems Implementation and Governance. In her role she supports internal systems used within PharmaLex as well as supporting clients.

At bluebird bio Tricia is currently a Senior Director of Regulatory Operations & Compliance responsible for leading the Project Management, Publishing Operations and Business Operations Management teams. Over the past three years, her team delivered multiple major marketing applications and built a robust set of tools to support organizational objectives and improve efficiency. Tricia’s previous experience at Biogen and Millennium/Takeda included various IT roles that allowed her to develop technical expertise and delivered solutions to her business partners. Tricia is focused on continuously improving processes and systems by applying technology and identifying opportunities to automate.

Nikki Qu holds a master’s degree in Graduate University of Chinese Academy of Science. She joined Bayer from 2009 till now and provided very good support on global regulatory activities of dossier publishing and submission; she owned rich experience and knowledge on eCTD publishing; especially for the recent emerging countries like GCC, ZA and other new eCTD countries.

I started my career with the TMF 6 years ago as an intern while earning my Master of Science in Information Studies degree. More recently I was the Manager of Clinical Documentation at AveXis where I was able to build the TMF from the ground up. There I was able to implement the Veeva Vault eTMF and author SOPs to support the business and system sides of TMF management. I have been involved and presented in multiple regulatory inspections and look forward to more in the future. In April of 2020 I joined Moderna as the TMF Manager. Since joining I have driven process and quality improvement initiatives, with the focus on aligning TMF management across the portfolio.

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.

Director, Regulatory and Head of RIM Strategy at Vertex Pharmaceuticals capitalizing on 20 years across the spectrum of pharmaceutical, consumer and medical device. My passion in management is a commitment to helping employees reach their highest levels of performance utilizing inherent skills and best-in-class technology. I am a visionary and innovator, while believing in the fundamentals of key performance indicators that demonstrate solid execution and measurable results. Technology within Regulatory and Quality is at a critical intersection and should be harnessed to improve cross--functional work, product speed to market and ultimately meet the underlying goal to serve patients and their medical needs.

Extensive industry experience in Regulatory Operations and Regulatory Information Management with proven success in the implementation of Regulatory processes, with emphasis on the creation and embedding of bespoke reporting solutions. In Daniel's current role as Regulatory Information Management Consultant at Calyx he has supported a variety of clients to effectively manage complex end-to-end regulatory processes, using the power of reporting to drive better business decision-making.

Chrystal Zhang is Senior Manager of Business Intelligence and Automation in Bayer Healthcare Co. Ltd, where she provides regulatory operation support to stakeholders globally. She holds M.Sc. degree in Biotechnology from Royal Institute of Technology in Sweden, and B.Sc. in Biology from Beijing Forestry University. Within Bayer, Chrystal has 9-year experience in regulatory information database maintenance and 2-year experience in CMC change management process coordination. Since 2018, she engaged in the Automation projects within RA department. In 2019, setup the Robotic Process Automation (RPA) in house development team and went live several bots in second year for various RA stakeholders.

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.

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.

Dominick has a proven track record in Project/Program Management and Regulatory Operations, meeting business-critical needs on time, on budget and with high quality by developing and leading cross-functional teams in identifying and implementing operational solutions. Dominick's experience and expertise includes pharmaceutical product development, regulatory submissions/operations, clinical operations, CMC, manufacturing, QA, new product launches, change management and business process improvement. Dominick's key accomplishments include managing teams through the submission and approval of four NDAs, two MAAs and multiple ANDAs, supplements & variations. Dominick holds a BS in Mechanical Engineering and currently pursuing his MBA.

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.

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.

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.

Isabelleis a professional facilitator at BioPhorum. Isabelle has over 20 years of experience working in the pharmaceutical industry. Her career first focused on the formulation, development and troubleshooting encountered during the manufacture of dosage forms and products. Her expertise is in the facilitation of problem solving both from a technical or an operational point of view. She has extensive knowledge and practice of accelerated delivery and project management tools that she now applies to the facilitation of regulatory teams in BioPhorum.

Dr. Mandello received her B.S. from the University of Georgia, and her DVM from The Ohio State University and has a passion for safety and innovation. Kristen brings more than a decade of global vigilance experience and develops creative solutions to efficiently meet global compliance standards and surveillance needs. Prior to joining Zoetis, as Head of the Global Pharmacovigilance at Merial (Sanofi's AH Division) and at Ennov, she lead development of automated systems to facilitate statistical signal detection, signal tracking and risk management for marketed pharmaceutical and biological products worldwide. Kristen is also an Associate Professor at University of Georgia's College of Pharmacy, International Regulatory Sciences Program.

I am a Clinical Development Associate Director responsible for Clinical Processes within Novartis and also a member of TransCelerate's Clinical Content and Reuse team. At DIA RSIDM, I sharing the journey of a sub team from CC&R that focused on Protocol Amendment Metadata Landscape Exploration.

JP Miceli is an Associate Director of Document Management for Advanced Clinical. JP started work at AC in September 2018 managing all TMF activities and staff, business development opportunities and budgeting, inspection readiness events, and acting as eTMF system owner. Prior to joining AC, JP’s background includes 20 years’ experience at companies including Shire Pharmaceuticals, Vertex Pharmaceuticals and Takeda Pharmaceuticals, with a primary focus on GxP records management and clinical documentation. JP has been a member of the TMF Reference Model group since 2010 and is currently a member of the Change Control Board, multiple Reference Model Zone subgroups, and the Heath Sciences and Records Archives Association (HSRAA).

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. I love conversations with disruptive thinkers, walking my dog and training in the local circus schoo

Efi Sergi is an Associate Director within PRA’s Regulatory Project and Submission Management group. She has been in the pharmaceutical industry since 2008 and has held various regulatory roles in the US and the UK. Efi has international regulatory submission management and strategic planning experience in key markets/regions and in-depth knowledge of local regulations and best practices in electronic and paper submissions. She has project managed several submission types, including but not limited to NDAs, MAAs, INDs, sNDAs, and Type II variations. Efi is a pharmacist by training and holds a Master of Science in Regulatory Affairs from Northeastern University, Boston, MA. Efi is also PMP-certified by PMI and a DIA and RAPS member.

Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry collaboration through a cloud-based data exchange model. Cesar supports efforts that permit the adoption of the Accumulus platform by both sponsors and regulators. Additionally, he leads a Topic Group Digitalization in Regulatory for IRISS, pushing forward industry-wide digital advancements. Cesar has over two decades of experience, the last 12 years he spent in Submissions Management leadership roles within Regulatory Operations at Pfizer.

I have been working in the pharmaceutical industry for more than 20 years. My career began working in pharmacy retail and I later started at Fujisawa Healthcare, now Astellas Pharma, in January 2001 in Pharmacovigilance. I shifted to publishing, after three years in Pharmacovigilance, in January 2004 and have worked in Publishing and Submission since that point. As a publisher, I assisted the team with the transition from paper to eCTD submissions. Over the past years, I have been the publishing lead or provided publishing oversight for several applications, including IND, NDA and BLA. Currently, I am the Director of the publishing team at Astellas with a team of primary publishers and outsource resources.

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.

For over 15 years’ I have been in Regulatory Affairs for large and small Pharmaceutical and Medical Device companies. I am currently Senior Regulatory Affairs Manager of Global Regulatory Affairs for Gan & Lee Pharmaceutical US Corporation. During my years in the industry, I have contributed to the production, manufacturing, registration, and marketing of medicinal products, that include biopharmaceuticals, Oligonucleotides, and orphan-drugs designated for specified rare diseases or conditions.

Michelle Charles, MPH is the Director of Regulatory Affairs in the Gene Therapy Program at the University of Pennsylvania, Perelman School of Medicine, providing guidance on global regulations, submission support and strategic regulatory planning. She co-chairs the DIA RSIDM Conference and has participated as a committee member for several years. Before joining the University of Pennsylvania’s Gene Therapy Program Michelle held multiple positions at both Merck & Co., Inc. and PAREXEL International. During her time in industry Michelle focused on regulatory operations, project management and business process development for global regulatory information management. Michelle holds a Masters of Public from Johns Hopkins University.

Daniel Chen is a Senior Consultant with Veeva's RIM Process Development Group. He was previously a Principal Product Manager at OpenText Life Sciences managing the company's EDMS and RIM products. Prior to becoming a technologist, he spent close to a decade in immune-oncology product development, using machine learning and robotics to automate and scale personalized biologics manufacturing. Daniel is RAC-certified and holds a Ph.D. in computational biology.

Susant Mallick comes up with 23+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial Intelligence, Machine Learning, IoT, Cloud etc) and an industry leading speakers across geographies. He has been working with various customers and partners in pharma and healthcare to drive digital transformation in clinical and regulatory landscape. He was instrumental in implementing/building many Regulatory solutions using advanced technology. Innovation and Digital Transformation in Healthcare and Life Sciences are two key focus areas.

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.