eCTD Submissions – Fundamentals and Process

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 Should Attend:

• 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.

Course Director: DANIEL ORFE ‎

Dan Orfe is an industry leader with 20+ years experience in Regulatory electronic submission production. He is a subject matter expert for electronic Common Technical Document (eCTD) solutions and associated tools that impact the upstream and downstream activities associated with eCTD sequence publishing and management. He is a business process analyst for efficient eCTD submission publishing, dossier management and outsourcing oversight. Dan has held eCTD responsibilities for a large Pharma (Merck), an eCTD software/service provider (Datafarm), an emerging Pharma (Radius) and a major generic Pharma (Teva). He has managed global eCTD production groups and has been accountable for the delivery of dozens of original New Drug Applications (NDAs)/Biologic Licensing Applications (BLAs)/Investigational New Drug submissions (INDs) to the FDA as well as corresponding filings to Health Canada, EMA and other regulatory agencies. In addition to the original eCTDs, Dan has been responsible for the delivery of thousands of eCTD sequences. Dan has also been responsible for vendor and outsourcing evaluation, selection and oversight. Dan has been a key member of several industry/agency initiatives to establish electronic submission standardization and efficiencies. He has presented and chaired sessions at DIA Annual Meetings and DIA Electronic Document Management (EDM)/Regulatory Submission, Information & Document Management (RSIDM) Conferences. He has served as Conference co-chair and Program committee member for DIA EDM/RSIDM Conferences. He was a technical representative to the Pharmaceutical Research and Manufacturer Association (PhRMA) Electronic Regulatory Submissions (ERS) task force for 10 years.