Regulatory Submissions, Information, and Document Management Forum
- Director Regulatory Information Management
- Qdossier - A Celegence Company, Netherlands
Michiel Stam is heading the Data Management group at Qdossier and works as a Regulatory Information Scientist. He is a specialist in electronic submissions and regulatory information management and worked for various Pharma and Biotech companies in the past 10 years. Michiel has a strong focus on product and registration data management, master data management and IDMP.
Karen McCarthy Schau
- Director, Global Clinical Operations
- Vertex Pharmaceuticals, United States
Clinical Research/Clinical Management Professional with 23 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.
- Associate Director, Program Management
- 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
- 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 Global R&D IT
- Bausch Health, United States
Jake Doran is the Head of Global R&D IT @ Bausch Health. In this role, Jake is responsible for establishing the strategic direction and defining the digital solutions across Bausch's R&D portfolio. Prior to joining Bausch Health, Jake was with Genpact, as the Chief Technology Officer focusing on the life sciences vertical. 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 Janssen Pharmaceuticals and Schering Plough. Jake has a Bachelor’s Degree from Fairleigh Dickinson University where his area of specialization was Biological Sciences.
- 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 about 20 years of global regulatory operations, project management and regulatory technology experience, with special focus on regulatory information management, data governance, publishing and global submissions strategy. Vahé has had various 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 a 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, United States
Cary Smithson is the Director of Regulatory Solutions at Phlexglobal 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, Regulatory Affairs
- 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 23 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, Clinical Documentation Management
- Regeneron Pharmaceuticals, United States
Joanne Malia is Director, Clinical Documentation 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 as co-lead of the Change Control Board for the TMF Reference Model group, on the organizing committee for DIA’s Regulatory Information Document Submission Meeting and presents frequently at industry conferences.
- Vice President, Business and Technology Consulting
- Just in Time GCP, 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
- Associate Director, Submission Management
- Bristol-Myers Squibb Company, United States
Sandy Krogulski is a Regulatory Submission Manager with 10 years of experience and this is her sixth RSIDM. She has experience managing and reviewing submissions to the US, Health Canada, Swissmedic, Australia and other Rest of World countries. In addition to submissions, Sandy has a background in training/developing teams, SOP writing and change initiatives. Currently in her third year with BMS, Sandy has previous vendor experience supporting submissions to numerous health authorities.
Rob Labriola, MS
- Exec. Director, Regulatory Operations
- 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 has a 25+ year regulatory career. Over the past 15 years he has worked in the electronic submissions field for both FDA and industry, including guidance promulgation, standards and process development, and system implementation. He is currently a Senior Principal Consultant for Pharmaceutical eConsulting with a focus on publishing. He has been responsible for numerous marketing applications and submissions to multiple regulatory authorities. Dan holds a bachelor’s degree in Psychology and Zoology 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 11 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.