CDER SBIA Webinar- Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria - October 12, 2016

On October 12, 2016, 1 PM EST, CDER SBIA will host a LIVE webinar titled: 
Study Data Standards within eCTD: What You Need to Know about the New Technical Rejection Criteria

This 60 minute webinar will provide an update on FDA’s requirements for the submission of standardized study data in NDAs, BLAs, ANDAs and INDs. Further, the webinar will present the core set of technical criteria that will be the basis for technical rejection of applications that do not conform to the required study data standards.

Specifically, the webinar will address topics such as:

• FDA’s electronic study data standards requirements in submissions
• Exemptions to the electronic study data standards requirements
• Understanding of the key validation criteria for the rejection of submissions not in conformance with the required study data standards
• Consequences for failure to submit study data in conformance to the required study data standards
• Study Data Technical Conformance Guide update on the use of Trial Design Model and Trial Summary Domain

We are very interested in addressing any questions or concerns and we will have a live Q and A session after the presentation.

This event has been pre-approved by RAPS as eligible for up to 1 credit towards a participant’s RAC recertification upon full completion.

Related Resources:

• Data Standards Catalog
• Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Standardized Study Data
• Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the FD&C Act
• Study Data Technical Conformance Guide

For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707

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