Drugs

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria - October 12, 2016

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The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), is pleased to announce the next webinar in our series.

The CDER SBIA webinars focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

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

This 60 minute webinar provided an update on FDA’s requirements for the submission of standardized study data in NDAs, BLAs, ANDAs and INDs. Further, the webinar presented 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 addressed 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.

The featured speakers will be:

Ron Fitzmartin
Senior Advisor
Office of Business Informatics
CDER

Virginia Hussong
Director of DDMSS
Office of Business Informatics
CDER

Lisa Lin
Senior Regulatory Analyst
Office of Business Informatics
CDER

Crystal Allard
Special Assistant to the Director
Office of Computational Science
CDER

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:

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


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