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Regulatory Content and Submissions Primer: Tracking Content from Conception to Interment


  • Betsy  Fallen, RN

    Betsy Fallen, RN

    • Consultant
    • BAFallen Consulting LLC, United States

    Betsy is an expert on business processes and technology. After 25 years at Merck & Co., as an independent contractor, she now supports sponsors, vendors and clinical sites in their innovation journey while ensuring compliance. Trained as an RN, she is dedicated to ensuring the patients experience is considered as the drug development process continues towards innovation.

  • Daniel F. Orfe, MS

    Daniel F. Orfe, MS

    • President and CEO
    • Regulatory eSubmissions, LLC, United States

    Dan has 20+ years of experience in Regulatory Operations and Submission publishing. Dan’s a subject matter expert in "cloud-based" eCTD and EDMS solutions providing consultation via Regulatory eSubmissions, LLC. At Radius he had responsibility for activities associated with production/delivery of regulatory filings & EDMS processes/tools. At Teva he oversaw an initiative to harmonize submission publishing and document management. At Datafarm he had responsibility for global Submission and Publishing Services. At Merck, Dan established and managed electronic submission production group. Speaker/session chair at 11 DIA Annual meetings, DIA EDM Conference Co-chair from 2009 through 2011 and DIA RSIDM Conference program committee member.