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