Medical Devices Technology Innovation Partnership (MD-TIP) Second Year Workshop
U.S. Food & Drug Administration & the University of Virginia
FDA Second Year Workshop MD-TIP
September 26, 2011
University of Virginia, Jordan Hall Conference Center
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?”
10:30am New frontiers in personalized
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
3:00pm National Medical Device
4:00pm Closing remarks
September 26, 2011 | 8:30am-4:30pm
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 firstname.lastname@example.org.
- David Chen
Director of Translational Research, UVA
- Kwame Ulmer
Deputy Director- Science and Policy
Center for Devices and Radiological Health
Food and Drug Administration
- Francis Kalush, Ph.D.
Diagnostics & Personalized Medicine Network Leader
Office of the Center Director