The Food and Drug Administration (FDA) is announcing a public meeting entitled “Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices.” The purpose of this meeting is to obtain input from academia, Government, industry and other stakeholders on the clinical application and scientific and technological challenges for performance validation of radiation biodosimetry devices.
- Date, Time and Location
- Federal Register Notice
- Agenda
- Registration
- Contact Us
Date, Time and Location
This meeting will be held September 27-28, 2012 from 8:00 a.m. – 5:00 p.m. at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center (Great Room, Room 1503)
Silver Spring, MD 20993
- FDA Campus Information
The meeting will be webcasted.
Agenda
This is a draft agenda. Speaker names and final topics will be added as details are finalized
September 27, 2012
8:00am-8:15am
Welcome and Announcements
8:15am-8:30am
Introduction and Purpose of the Meeting
Topic: Development Challenges for Radiation Biodosimetry
8:30am-9:00am
Academic Perspective
9:00am-9:30am
BARDA Perspective
9:30am-10:00am
DOD/AFRRI SME Perspective
10:00am-10:30am
Break
10:30am-11:30am
Public Presentations (3 15 min presentations w/ 5 min questions)
11:30am-12:00pm
Panel Discussion
12:00am-1:00pm
Lunch
Topic: FDA Regulatory Process for Radiation Biodosimetry
1:00pm-1:30pm
FDA regulation of Medical Countermeasures
1:30pm-2:00pm
CDRH regulation of Medical Countermeasures
2:00pm-2:30pm
Emergency Use Authorization
2:30pm-3:00pm
Break
3:00pm-4:00pm
Panel Discussion
4:00pm-4:30pm
Wrap-up and Summary – Tremel Faison
September 28, 2012
Topic: The Use of Animal Models in Radiation Biodosimetry Efficacy Testing
8:15am-8:30am
Introduction and Summary of Yesterday – Tremel Faison
8:30am-8:50am
GLP and Partial Body Models
9:00am-9:30am
Rodent models
9:30am-10:00am
Group to Link nonhuman Primate and Human radiation effects
10:00am-10:30am
Break
10:30am-11:30am
Public Presentations (3 15 min presentations w/ 5 min questions)
11:30am-12:00pm
Panel Session Discussion
12:00pm-1:00pm
Lunch
Topic: Clinical Application and Public Health Need of Radiation Biodosimetry
1:00pm-1:30pm
Clinical Perspective
1:30pm-2:00pm
CDC Perspective
2:00pm-2:30pm
Local Perspective
2:30pm-3:00pm
Break
3:00pm-4:00pm
Public Presentations (3 15 min presentations w/ 5 min questions)
4:00pm-4:30pm
Panel Discussion
4:30pm-5:00pm
Wrap-up and Summary
Registration to Attend the Workshop
If you wish to attend this Workshop, you must register by close of business on September 13, 2012.
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 an 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 Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, WO-66 Room 4321, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, email: [email protected].
Contact Us
For questions regarding workshop content please contact:
Jennifer Dickey
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, WO-66 Room 4254
Silver Spring, MD 20993
301-796-5028
email: [email protected]