Workshops & Conferences (Medical Devices) > Public Workshop - Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests, November 12, 2015

Workshops & Conferences (Medical Devices) > Public Workshop - Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests, November 12, 2015

Public Workshop - Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests, November 12, 2015

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests.” The purpose of this workshop is to obtain feedback on possible analytical standards and approaches to develop or build on existing standardization efforts in order to optimize FDA’s regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests. Comments and suggestions generated through this workshop will also guide the use of regulatory science to advance the further development of appropriate and relevant performance standards for evaluation of next generation sequencing in vitro diagnostic tests that produce results on variation in the human genome.
 

• Date, Time and Location
• Federal Register Notice
• Agenda
• Registration
• Contact Us

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Date, Time and Location

This meeting will be held November 12, 2015, beginning at 8:00 am – 5:00 pm at the following location:

FDA White Oak Campus 
10903 New Hampshire Avenue 
Bldg. 31, Room 1503 (the Great Room) 
Silver Spring, MD, 20993

FDA Campus Information (Airports, Directions, Lodging Accommodations, Public Transportation, etc.)

The meeting will be webcast.

Agenda

The preliminary agenda will be posted.

Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by close of business on October 30, 2015. When registering, you must provide the following information:

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to make an oral presentation during the open comment session at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

Attendance  In-Person   Webcast Title     Mr. Mrs. Ms. None First Name* Last Name *   M.D.     Ph.D. Email* Please enter Email again for verification : Phone Number*  (No dashes or spaces in phone numbers please) Company or Organization * Request to Speak * Do you wish to make a presentation?  Yes  No Topic you wish to address:  Experience and/or Expertise

Contact Us

For questions regarding workshop content please contact:

Zivana Tezak, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Silver Spring, MD 20993, Tel. 301-796-6206, email: zivana.tezak@fda.hhs.gov.