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Medical Devices Technology Innovation Partnership (MD-TIP) Second Year Workshop
U.S. Food & Drug Administration & the University of Virginia
Charlottesville, Virginia
FDA Second Year Workshop MD-TIP
September 26, 2011
University of Virginia, Jordan Hall Conference Center
Full agenda
Registration
Agenda (in brief)
8:30am Introduction to Medical Technology Innovation Partnerships Second Year Workshop
9:00am Initiatives in science and innovation at FDA Center for Devices and Radiological Health
9:30am “I am an academic but want to translate my technology, what can FDA do for me?”
10:15am Break
10:30am New frontiers in personalized medicine
11:45am–1:00pm Focused lunch discussions: Cancer biomarkers OR Cardiovascular device development
1:15pm–3:00pm Educational sessions: Pre-IDE submissions and IDE, Bioresearch Monitoring (BIMO) Requirements, Preclinical testing considerations, Clinical study design considerations
3:00pm National Medical Device Curriculum Development
4:00pm Closing remarks
Sponsors



September 26, 2011 | 8:30am-4:30pm
Agenda
Registration
Presentations
On September 26, 2011, the University of Virginia will co-sponsor a U.S. Food & Drug Administration (FDA) workshop on medical device innovation, regulation, device education and translational research on September 26. The workshop is part of the FDA’s Medical Technology Innovation Partnerships (MD-TIP) Project, now in its second year.
The central idea is to enhance the U.S. regulatory process through proactive collaboration with U.S. research universities and emerging entrepreneurs. The clinical focus of the Sept 26 workshop is emerging technologies in personalized cancer diagnostics and cardiovascular device development. Afternoon breakout sessions will cover the regulatory process from first communication through clinical study design. The day will conclude with a discussion of a National Medical Device Development Curriculum.
Fifteen staff members from the FDA’s Center for Device and Radiological Health (CDRH), including division directors, inspectors and network leaders, will be on hand to collaborate with researchers, entrepreneurs, technology transfer offices and students.
This event is free of charge. To attend, contact Angel Thompson at angelt@virginia.edu.
- David Chen
Director of Translational Research, UVA
phone: 434-243-7357
email: davidchen@virginia.edu
- Kwame Ulmer
Deputy Director- Science and Policy
Center for Devices and Radiological Health
Food and Drug Administration
phone: 301-796-6471
email: Kwame.Ulmer@fda.hhs.gov
- Francis Kalush, Ph.D.
Diagnostics & Personalized Medicine Network Leader
Office of the Center Director
phone: 240-205-9704
email: Francis.Kalush@fda.hhs.gov
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