This public workshop on next-generation sequencing (NGS) technology, data formats standardization and promotion of interoperability protocols aims to facilitate establishing protocols for ensuring the safety and quality of next-generation sequencing (NGS)-related-information without sacrificing scientific merit or interfering with innovative processes. This will be achieved by engaging NGS stakeholders in a forum to discuss the current use of NGS technology and the development of standards for related information.
In addition, it will highlight FDA-proposed guidelines for addressing NGS data storage, archival and quality control steps needed for computational biology protocols related to FDA relevant regulatory science.
Transcripts from Workshop:
Conference Draft Documents
September 24-25, 2014
8:30 a.m. to 5:00 p.m.
The National Institute of Health Campus
9000 Rockville Pike , Bldg. 35 Rm. 610
Bethesda, MD 20892
Logistics and Arrival Details Here
Please note: We have reached full capacity for in-person attendance. However, you may register to attend remotely. To do this, please select “remote attendance list." More information about remote access will be available in the coming weeks.
Workshop organizer: FDA Genomic Working Group
FDA's Genomic Working Group consists of experts in high throughput sequencing technology application and bioinformatics relevance. The group's goal is to develop the IT infrastructure, material and data standards, and analytic approaches that are required to support use and application of this exciting new technology to solve scientific questions and support regulatory decision-making.
It also aims to ensure that the resources and expertise required are identified, implemented, and developed in a coordinated fashion, both internally at FDA, and where feasible, with other government agencies.
This is the final agenda for this public workshop.
For remote participation please go to:
Use the call-in number and participant code below for questions:
Call in number: 800-369-3124
Participant passcode: 2088649