OFFICE OF RESEARCH COMPLIANCE presents RESEARCH COMPLIANCE MATTERS RESEARCH COMPLIANCE WORKSHOPS Fall 2007 WORKSHOP “Device Advice: Common Pitfalls for Investigators in Medical Device Clinical Studies” Speaker: Norma Epley, M.P.H. Asst. Director, Division of Research Integrity & Compliance, USF Human Research Protections Program As a result of participation in this activity, participants will: Have a working understanding of applicable medical device regulations Understand the IRB’s role from the beginning of the device development project Evaluate significant versus non-significant risk and custom versus non-custom devices Understand considerations in the emergency, compassionate and humanitarian use of devices Friday, November 30, 2007 Children’s Medical Service Building (CMS) 3048 (Directions Below) Lecture & Workshop 11:45 to 1 p.m. LUNCH PROVIDED LIMITED PARTICIPATION —CALL TODAY TO RESERVE YOUR PLACE: CHARMAINE DISIMILE 974-7715 http://health.usf.edu/research/compliance/Training+Workshops+and+Seminars.htm