eCTD Submissions – Fundamentals and Process

  • Product Id : FDB2320
  • Category : , , ,
  • Presenter :
  • Scheduled On : July 27 2017 1:00 pm
  • Duration : 90 Minutes

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 technical validation standards can result in refusal from health authorities. Health authorities are raising the bar for quality, compliant eCTDs 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. Other regulatory agencies are also moving to mandate eCTD delivery starting in 2018. Provide yourself and your company an understanding of the technical skills and regulatory requirements necessary to meet the impending eCTD mandates.

At the conclusion of this session, attendees will be able to:

  • Identify fundamental strategies for preparing eCTD submissions
  • Explain the technical requirements of eCTD submissions
  • Demonstrate an awareness of the best practices for use of MS Word and Adobe Acrobat in preparing content for eCTD submissions
  • Submit an eCTD that is compliant with health authority requirements – whether produced in-house or by an outsource eCTD publisher
Areas Covered in the Session :

  • Electronic submission requirements of eCTD
  • Best practices to leverage within MS Word and Adobe Acrobat to produce files for eCTD submissions
  • What defines compliance for PDF files (document level publishing)
  • What defines compliance for eCTD submissions (submission level publishing)
  • Interactive Q&A Session
Who Will Benefit:

  • Clinical, safety assessment and chemistry/quality professionals responsible for the creation of content to be used in submissions to regulatory agencies.
  • Regulatory professionals associated with content delivered to regulatory agencies and subsequent interactions with those agencies.
  • Regulatory Operations professionals looking for an understanding of the eCTD genesis and process or new to roles within eCTD publishing.

FDB2320

Daniel Orfe

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.

Featured Webinars :

Design of Experiments for Non-Statisticians
Good Documentation Practices to Support Computer System Validation
Understanding and Implementing a Quality by Design (QbD) Program
Process Verification and Validation

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  • Presentation Handout in .pdf format
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