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:
- 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
Attendees will learn:
- 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)