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Course 2: Essentials for Compiling/Publishing Compliant Electronic Submissions (eCTDs)


Instructors

  • Jillian E. Carinci, MS

    Jillian E. Carinci, MS

    • Associate Director, Regulatory Operations
    • Accenture Regulatory, United States

    Jillian partners with sponsors to manage numerous regulatory submission projects. She ensures compliance with global regulatory requirements, delivering within scope, on time, and with the highest quality. She has managed original applications to regions including the US, EU, and CH, and lifecycle maintenance submissions. Jillian holds a Bachelor’s degree in Chemistry from Lafayette College and a MS in Regulatory Affairs and Quality Assurance from Temple University.

  • Daniel F. Orfe, MS

    Daniel F. Orfe, MS

    • President and CEO
    • Regulatory eSubmissions, LLC, 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.).