Course 2: Essentials for Compiling/Publishing Compliant Electronic Submissions (eCTDs)
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
- 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.
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Other Preconfernce Short Courses