Workshops & Conferences (Medical Devices) > Public Workshop - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants, November 13, 2015

Workshops & Conferences (Medical Devices) > Public Workshop - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants, November 13, 2015

Public Workshop - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants, November 13, 2015

The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants”. The purpose of this workshop is to obtain feedback on ways in which FDA can use curated databases containing information about human genetic variation as sources of valid clinical evidence for the Agency’s oversight of the next-generation sequencing (NGS)-based in vitro diagnostic tests (IVDs). Comments and suggestions generated through this workshop will guide the development of best practices and/or regulatory standards for reliance on external curated databases.

• 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 13, 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 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:

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 Proposed title of presentation:  Discussion Topic Experience and/or Expertise

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 any of the open comment sessions 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.

Contact Us

For questions regarding workshop content please contact:

David Litwack, 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. 301-796-6697, email: ernest.litwack@fda.hhs.gov.