Clindata is proud to sponsor the next SF Bay Area CDISC meeting being held on February 9, 2017 at 12:30-4:30 PM at the South San Francisco Conference Center.
Scheduled as one of the speakers will be our very own Kevin Lee, Director of Data Science at Clindata. His presentation is on
How Will The New FDA Technical Rejection Criteria and Rejection Process Impact CDISC Data Submissions
Beginning Dec 18, 2016, all clinical trial and nonclinical trial studies must use standards (e.g., CDISC) for submission data and beginning May 5, 2017, NDA, ANDA, and BLA submissions must follow eCTD format for submission documents. In order to enforce these standards mandates, the FDA also released "Technical Rejection Criteria for Study Data" in FDA eCTD website on October 3, 2016. FDA also implemented a rejection process for submissions that do not conform to the required study data standards.
The presentation will discuss how these new FDA mandates impact the electronic submission and the required preparation for CDISC and eCTD complaint submission package such as SDTM, ADaM, Define.xml, SDTM annotated eCRF, SDRG, ADRG and SAS programs. The presentation will introduce the current FDA submission process, including the current FDA rejection processes – “Technical Rejection” and “Refuse-to-File”. It will also demonstrate how FDA has used “Technical Rejection” and “Refuse-to-File” to reject submission. The presentation will show how FDA plan to use “Technical Rejection Criteria for Study Data” for non-CDISC data submission. The presentation will also discuss how the rejection will impact sponsor’s submission process, and how sponsors should respond to FDA rejections as well as questions throughout the whole submission process. Use cases will demonstrate the key technical rejection criteria that will have the greatest impact on a successful submission process.
Other speakers will be there to share their latest knowledge and expertise in the CDISC area.
- South San Francisco Conference Center
- Thursday, 09 February 2017
- 12:30 - 4:30 PM