Regulatory Submissions, Information, and Document Management Forum
- Director Regulatory Information Management
- Qdossier - A Celegence Company, Netherlands
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.
Karen McCarthy Schau
- Director, Risk-based Study Management
- Vertex Pharmaceuticals, United States
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.
- Program Director
- Transcelerate Biopharma Inc., United States
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, MBA, MS, PMP
- Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
- FDA, United States
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 and Business Intelligence programs. While leading the CDER Division of Data Management Service and Solution, Ethan had successfully implemented the eCTD electronic submission mandate in 2017 for NDAs, BLAs and ANDAs, and again in 2018 for Commercial INDs and DMFs (excluding DMF Type III). Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.
- Head of Digital
- MAPS Public Benefit Corporation (MAPS PBC), United States
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.
- Vice President, Regulatory Information Management
- Calyx, United Kingdom
An established Regulatory Information Management expert with extensive skills and experience in life sciences. As the VP of Regulatory Information Management at Calyx Jo is the operations lead and the business owner for the Calyx RIM suite. The operations team are responsible for strategic consultancy and delivery of services and solutions to facilitate our clients’ business using the Calyx RIM suite and other RIM technologies. The operations team remit is to ensure that the Calyx RIM suite aligns with the changing regulatory landscape and client needs and to provide strategic regulatory input into the software development lifecycle. As the business owner Jo is responsible for the overall budget to align with Calyx fiscal requirements.
Vahe Ghahraman, PhD
- Senior Director, Global Regulatory Operations Head
- Apellis Pharmaceuticals, Inc. , United States
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 Sauter, MBA
- Director, Global Regulatory Informatics & Analytics
- Takeda Pharmaceuticals, United States
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, MBA
- Director Regulatory Solutions
- Phlexglobal, A Pharmalex Company, United States
Cary Smithson is the Director of Regulatory Solutions at Phlexglobal, a PharmaLex company, and has over 25 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 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, MS
- Senior Advisory Consultant, Life Sciences
- NNIT, United States
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 Buno, MBA
- Sr. Director, Regulatory Submissions
- Abbvie, Inc., United States
Alison is Sr. Director, Regulatory Affairs Submissions at AbbVie Inc. She has 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, MS, MSc
- Director, Development Records Management
- Regeneron Pharmaceuticals, United States
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.
- Head, Clinical and Regulatory Consulting Services,
- Astrix, United States
Mr. O’Keefe has over 15 years of R&D management and IT consulting expertise, working with both top tier pharmaceutical firms, and early stage biotechs. Prior to joining Just in Time GCP as Vice President of Business & Technology Consulting, 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.
- Associate Director, Regulatory Information Management
- BeiGene, United States
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.
Sandra Krogulski, MA
- Director, GRSO Innovation and Business Operations Lead
- Bristol-Myers Squibb Company, United States
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 Labriola, MS
- Exec. Director, Regulatory Operations
- Certara Synchrogenix, United States
Rob oversees the Regulatory Operations services group at Synchrogenix, a Certara Company. His over 35 years-experience in leadership positions of increasing responsibility managing high technology programs and initiatives, include over 25 years expertise in Regulatory Operations. He was an early planner and adopter for the electronic Common Technical Document (eCTD), having previously serving on Bio and PhRMA working groups for eCTD and electronic submissions. Rob is a builder and leader of teams of all sizes, including past roles at Janssen, Millennium, Sunovion, and Alexion. His submissions experience includes coordinating submissions for investigational and marketing programs, and has been an operator, planner, gatekeeper and champion.
- Principal Consultant
- eSub Solutions, United States
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. He has been responsible for thousands of submissions to multiple regulatory authorities. Dan holds a bachelor of science degree from Duke University.
Jonathan Resnick, PMP
- Project Management Officer, OBI, OSP, CDER
- FDA, United States
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 12 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.
Jan Benedictus, MS, MSc
- Managing Director
- Fonto, Part of RWS, Netherlands
Jan Benedictus is founder 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 increasinlgy in Pharma. 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.
Tamei Elliott, MS
- Senior Manager, Scientific Programs
- DIA, United States
Tamei Elliott is the Senior Manager of Scientific Programs for the Americas Region at DIA. She is responsible for identifying and prioritizing content areas and topics of importance to DIA constituents, assessing the implications of important regulatory and health policy changes, and incorporating appropriate content into the development and advancement of content for DIA conferences and courses. Prior to DIA, Tamei worked as a Regulatory Affairs Specialist where she maintained a portfolio of INDs and protocols for clients and was responsible for the preparation, tracking, and submission of regulatory documents to regulatory health authorities. She has her master's degree in biotechnology and bachelor's degree in nutritional science.
Ron Fitzmartin, PhD, MBA
- Senior Informatics Advisor, Office of Regulatory Operations, CBER
- FDA, United States
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.
Venkatraman Balasubramanian, PhD, MBA
- SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
- Orion Innovation, United States
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 A. Gray
- Senior Project Manager, DSB, CBER
- FDA, United States
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.
- Technical Solutions Consultant
- Calyx, United States
- Chief Product Officer
- Adlib Software, Canada
Robert C. Schilling
- Project Manager
- PPD Development, United States
- Vice President Regulatory Operations Information and Compliance
- Daiichi Sankyo, United States
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.
Daniel Orfe, MS
- President and CEO
- United States
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, MSc
- Senior Regulatory Affairs Consultant
- Qdossier, A Celegence company, Netherlands
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.
- Digital and Data Lead, Regulatory Affairs
- Genpact, United States
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, MA
- Director, Innovation & Information Management
- Merck & Co., Inc., United States
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, MBA
- Montrium, Canada
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, MS
- Managing Partner
- Gens & Associates Inc., United States
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.
- Sr. Director, Integrated Global Compliance Solutions
- IQVIA, United States
Paul Richard Ireland
- VP Life Sciences
- DocShifter, Belgium
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.
- Director Product - RIMS
- Arisglobal, United States
Thomas P Kivlehan
- Chief Data Officer
- Docxonomy, United States
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, MBA
- Executive Director, Transformation and Business Informatics, RMOD, HPFB
- Health Canada, Canada
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.
Ivana Miljkovic, MSc
- Senior Consultant - Information Management
- OSTHUS Gmbh (a Company of Pharmalex), Germany
Ivana Miljkovic is a senior data & IT strategy consultant supporting leading life science companies to define strategy and technology solutions in areas of knowledge management and FAIR data, reference/master data management and digital transformation. Being a part of the data standardization initiatives in pharma industry in the past years, she is now involved in the Pistoia Alliance’s IDMP Ontology initiative aimed to enable semantic interoperability of product data assets.
Gerhard Neurauter, DrSc
- Head of Regulatory Competence Center
- EXTEDO GmbH, Germany
Gerhard leads the Regulatory Competence Center at EXTEDO GmbH in Munich, Germany., which serves as the backbone for EXTEDO’s regulatory competence and ensures the life sciences business operates compliant. Gerhard is responsible for all aspects of regulatory intelligence at EXTEDO which includes eCTD, IDMP, PV, PP and supports EXTEDO to explore new innovations and markets. With now more than 25 years of life sciences industry expertise, he has a deep understanding of the underlying regulatory business processes of the pharmaceutical industry and the national competent authorities. Gerhard graduated in analytical chemistry at the Karl-Franzens-University of Graz,Austria and holds a doctorate degree from the University of Regensburg,Germany.
Keith Parent, MS
- Court Square Group, United States
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.
Neel Patel, MS
- Principal Consultant
- Red Nucleus, United States
Andrew Potter, PhD
- Mathematical Statistician, OB, OTS, CDER
- FDA, United States
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
- Sr. Director of Content Strategy Solutions
- Content Rules, Inc., United States
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 Fallas, PharmD, MSc
- International Regulatory Team Lead
- F. Hoffmann-La Roche Ltd, Switzerland
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.
Cassandra San Jose, MS, PMP, RAC
- Director, Submission Planning and Resource Management
- Biogen, United States
- Senior Regulatory Data Specialist
- Qdossier, a Celegence company, Netherlands
Mary Ann Slack
- Director, Office of Strategic Programs, CDER
- FDA, United States
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, MSc
- Managing Director
- Iperion Life Sciences Consultancy, Netherlands
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.
- Associate Director, Regulatory Informatics and Analytics
- Takeda Pharmaceutical Company Limited, United States
Geert Van Peteghem, MBA
- DocShifter, Belgium
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.
- President and CEO
- LMK Clinical Research Consulting, United States
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 Agard, MS, RPh
- Team Leader, Clinical Consulting US
- NNIT, United States
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.
Maria Barhams Sagoua, MHA
- Principal Industry Consultant
- SAS, United States
Maria is a Principal Consultant in SAS’s business development practice primarily working with Federal Health clients like the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH). In this role, she focuses on collaborating with government agencies on their journey toward enterprise and digital transformation. She has nearly two decades of experience working in both the public and private sectors applying data, analytics, and public health strategies to modernize FDA’s new drug regulatory review and drug safety processes; generate body of evidence to revise clinical guidelines for risk stratification of a rare disease and improve the clinical management of atrial fibrillation patients in primary care settings.
Stephen Blanchard, MS
- IDMP Programme Lead
- Johnson & Johnson Consumer Health, United Kingdom
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.
- Regulatory Services Manager
- Certara Synchrogenix, United States
Rachel Bombara is a Regulatory Services Manager at Certara Synchrogenix with over a decade 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.
William Bryant, MBA
- Point B Consulting, United States
- Global Regulatory Affairs Operating Leader
- Genpact, United States
Jason Cober, MPA
- Lead Project Manager, OPDP, CDER
- FDA, United States
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 10 years experience with the Agency's eCTD specification and guidance development process.
Lina Cong, MS
- Senior Health Informatics Officer, OBI, CDER
- FDA, United States
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.
- Director, RA Submission Management
- Abbvie, United States
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 Francois Denarie, MBA
- Senior Principal, Regulatory Affairs and Drug Development Solutions
- IQVIA, United States
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.
- Senior Business Consultant
- EXTEDO Gmbh, Germany
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
Jason Hirschhorn, MBA
- Point B, United States
- Manager, Global Regulatory Affairs Solutions
- Syneos Health, United States
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, BSN, RN
- Senior Director Innovation and Information Management
- Merck & Co., United States, United States
Leslie Kitchen is a Senior Director in the 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, Chief-of-Staff, and Business Development, Sourcing, and Alliance Management. In her current role at Merck, she leads an Information & Communication Management group focusing on developing and supporting innovative digital solutions to manage information across Global Regulatory Affairs.
- Senior Director, US Site Head Regulatory Submission Management
- Bayer U.S. LLC, United States
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, MA
- Senior Director, Regulatory Affairs Operations
- Atara Biotherapuetics, United States
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, PhD
- CEO and Co-Founder
- Accurids GmbH, Germany
Heiner Oberkampf is the CEO and Co-founder of ACCURIDS, which is a data registration software that helps pharma companies 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.
Donald Palmer, MA
- Senior Regulatory Affairs Director; Business & Technology Transformation
- IQVIA, Inc., United States
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.
Sarah Powell, RAC
- Powell Regulatory Services, United States
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 19 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
- Team Manager, US Publishing Team
- Pfizer, Inc., United States
Leonardo Nascimento Santos
- Health Regulation Specialist, Office of Drug Products
- ANVISA, The Brazilian Health Regulatory Agency, Brazil
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.
- Managing Director
- FTI Consulting, Inc., United States
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.
Hans van Bruggen, MSc
- Qdossier, a Celegence Company, Netherlands
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.
Yusuf Azzeddine Leenen
- Regulatory Operations Associate
- Qdossier, Netherlands
- Product Manager, Regulatory Technology
- IQVIA, United States
Gary Colantonio, MBA, MS
- Assoc. Dir, Regulatory Affairs
- Merck, United States
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, MS
- Sr Director and Process Owner, Clinical Trial Foundations
- Eli Lilly and Company, United States
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, MA, MSc
- Master Data Manager
- Bayer, Germany
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.
Hilmar Hamann, PhD
- Head of Information Management Division
- European Medicines Agency, Netherlands
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.
- K2 Consulting, United States
Kelly is a recognized industry leader in RIM and IDMP with nearly 30 years in the pharma industry, the last 16 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.
- Executive Director
- PharmaLex, Taiwan
John Jones, MBA
- Entitech Solutions, United States
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 Lagrave, PharmD
- VP of Regulatory Innovation
- Accumulus Synergy, United States
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 VP 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.
Jason Mattis, MBA, MSc
- Director, Regulatory Affairs CMC
- Johnson & Johnson, United States
- Director of Client Success
- Glemser Technologies, United States
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 Robert Schmuff, PhD
- Associate Director for Science, OPMA, OPQ
- FDA, United States
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.
Olaf Schoepke, PhD
- Vice President, Regulatory Solutions
- Instem, United Kingdom
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.
- Supervisary Program Analyst
- FDA, United States
Mr. Ta has worked in the IT industry for over 30 years and possesses extensive experience in implementing IT projects. Prior to joining the FDA, Mr. Ta worked for large corporations such as IBM, Lockheed Martin, and others. At FDA, he supported various informatics initiatives for the Center for Drug Evaluation and Research and Office of Regulatory Affairs such as the Structured Product Labeling and Laboratory Management. Currently, Mr. Ta is with the Office of Digital Transformation as Senior Technical Advisor managing multiple enterprise efforts, including the next generation for the electronic submission gateway.
Siva Thiagarajan, MBA
- Associate Partner
- ZS Associates, United States
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.
- Managing Consultant
- NNIT, United States
Adair Turner, MSc, RAC
- Sr. Director, Head of Regulatory Affairs US
- PharmaLex, United States
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.
- Director and Head of Global Regulatory Policy & Intelligence
- Seagen Inc., United States
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.
- Advisory Managing Director, Life Sciences
- KPMG, United States
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, IDMP preparation, data cleansing/harmonization and adoption of emerging digital technologies.
Akira Yamaguchi, MBA
- Chief Technical Officer
- LORENZ Life Sciences Group, United States
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.
Christopher Joneckis, PhD
- Associate Director for Review Management, CBER
- FDA, United States
Seyoum Senay, MS
- Supervisory Operations Research Analyst, CDER/OBI
- FDA, United States
Mr. Senay is leading the FDA CDER mission-critical Informatics initiatives in support of human drug regulatory review and approval process. Consistently demonstrated exemplary leadership and received FDA commissioner’s award for leading Informatics modernization. Leveraging CDER NextGen Portal, successfully reduced regulatory overhead for sponsors, research institute, academia, and small businesses. In addition, Mr. is the U.S Excellence in Government Leadership Fellow (EIG) to solve national problems by driving innovation, inspiring employees, and delivering results. Mr. Senay holds a master’s degree in Information Systems from The Johns Hopkins University and a Certified Program Manager by the U.S Federal Acquisition Institute.
- Director, InforMaster Data Management & Data Governance
- Merck & Co., Inc, United States
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, MBA
- Executive Director, Regulatory Information & Submission Management
- Bristol Myers Squibb, United States
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, MBA, MS
- Director, Data Standards Staff, OSP, CDER
- FDA, United States
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.
On-Demand Content Preview Webinar
Preconference Short Courses
Additional InformationDiscover DIA’s Live In-Person Events
Download and fill out our Justification Letter