Electronic Common Technical Document (eCTD) submissions that fail the technical validation standards can result in refusal from health authorities. Since the passage of The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, global regulatory agencies have begun to standardize on eCTD format. Furthermore, health authorities are raising the bar for these technical validation standards due to the pressure to meet review timelines. Beginning May 5, 2017 the FDA has mandated that nearly all submission types to be delivered in eCTD format.
Every regulatory professional should have a solid understanding of the standards, groundwork, expertise and technology required to submit compliant eCTD submissions. This begins with understanding what will be accepted and what will not. Put yourself and your company a step ahead of competitors by understanding the technical skills and regulatory requirements necessary to meet the impending eCTD mandates.
At the conclusion of this 90-minute session, participants will be able to:
Attendees will learn:
This course will be of special benefit to those in clinical through regulatory roles who need a firm understanding of eCTD submissions, especially in advance of looming regulatory agency deadlines for eCTD submissions.
Daniel F. Orfe is a Leadership professional with 20+ years experience in Regulatory eSubmission production and 30+ years experience in support of the Life Science industry. Presently managing Regulatory eSubmissions LLC, providing subject matter expertise focused on "cloud-based" eCTD and EDMS solutions. Dan is recognized within the industry as an executive level change agent and business process analyst for efficient submission assembly, dossier management and eCTD/eCTD life-cycle production.
He has been a key member of several industry/agency initiatives to foster electronic submission standardization and efficiency. Valued for his experience on the topic of eSubmissions, Dan has presented or chaired sessions at 11 of the past 14 DIA Annual Meetings and was conference co-chair for the DIA Electronic Document Management (EDM) Conference in 2009, 2010 and 2011. Dan presently serves as a program committee member for the DIA Regulatory Submissions, Information, and Document Management Conference (RSIDM).
Dan was responsible for the establishment and management of eSubmission production groups at Merck & Co., Inc. and Datafarm Inc. Areas of expertise include regulatory submissions strategy and business / technology process improvements; uniquely adept at identifying innovations which facilitate the automation of activities for efficiency and error reduction.
Dan established and managed the Electronic Submissions group at Merck. This group of 10 people located in the US, Canada, EU, and Japan produce over 300 eCTD/eSubmission deliverables per month. Merck’s achievements within this field established the team as an industry direction setter and submission delivery record setter. Dan oversaw Datafarm's Regulatory Services Group; directing the company’s electronic submission publishing and management activities; and providing strategic support for the further expansion of Datafarm's Submission Services. At Teva, Dan oversaw the harmonization of worldwide electronic submission publishing and document management. At Radius Inc., Dan was responsible for eCTD and EDMS activities, processes and tools.