Dan Orfe, President & CEO, eRegulatory Submissions LLC, is a Leadership professional with 20+ years experience in Regulatory eSubmission production. He is a subject matter expert for “cloud-based” eCTD & EDMS solutions and business process analyst for efficient submission assembly, dossier management and eCTD production.
He has been a key member of several industry/agency initiatives to foster electronic submission standardization and efficiency. Dan presented or chaired sessions at several DIA Annual Meetings and DIA EDM Conferences, DIA Electronic Document Management (EDM) Conference Co-chair in 2009, 2010 & 2011, as well as Program committee member for the DIA RSIDM Conference. He has directed eSubmission production groups at Merck & Co., Inc. and Datafarm Inc.
Regulatory professionals need a solid understanding of the standards, groundwork, expertise, and technology required to submit compliant Electronic Common Technical Document (eCTD) submissions. This begins with understanding what will be accepted and what will not. eCTDs that fail the...