Announcements - FDA Presents "Using Devices in Clinical Trials"...

CCTSI Group

Regulatory

Title

FDA Presents "Using Devices in Clinical Trials"

Date

6/8/2009

Body

Colorado Clinical and Translational Sciences Institute (CCTSI)
University of Colorado Denver

Using Devices in Clinical Trials
Presented by the Food and Drug Administration

You are invited. Admission is free.

The Food and Drug Administration will be at the University of Colorado Denver Anschutz Medical Campus on June 8th and 9th to discuss rules, regulations, and responsibilities when using devices in clinical trials.

All sessions are being held in Research 1North P18-1000 in the Hensel Phelps Auditorium-East.

Sponsored by the Regulatory Knowledge and Support Core of the Colorado Clinical and Translational Sciences Institute.

AGENDA

MONDAY, JUNE 8, 2009

TIME	SESSION	TARGET AUDIENCE
9:00am-10:00am	Introduction to Medical Devices and Medical Device Trials	PIs, Clinical Trial Coordinators, Regulatory Staff, Clinical Trial Staff
10:00am-10:45am	Responsibilities of Medical Device Clinical Sponsors and Sponsor/Investigators	Those who might apply for or hold an IDE or HDE
11:00am-12:00pm	Use of Computerized Systems in Medical Device Trials	PIs, Clinical Trial Coordinators, Regulatory Staff, Clinical Trial Staff
2:00pm-4:00pm	FDA Inspections of Clinical Investigators	PIs, Clinical Trial Coordinators, Regulatory Staff, Clinical Trial Staff
4:00pm-6:00pm	Responsibilities of Orthopedic Clinical Investigators	PIs, Clinical Trial Coordinators, Regulatory Staff, Clinical Trial Staff using orthopedic devices

TUESDAY, JUNE 9, 2009

TIME	SESSION	TARGET AUDIENCE
7:00am-9:00am	Responsibilities of Oncology Clinical Investigators	PIs, Clinical Trial Coordinators, Regulatory Staff, Clinical Trial Staff
9:00am-10:00am	Responsibilities of Medical Device Clinical Investigators	PIs, Clinical Trial Coordinators, Regulatory Staff, Clinical Trial Staff

No registration is required.
These presentations are consistent with 21 CFR 10.85 (k) and constitutes informal communications that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

For more information contact:
Yvonne Kellar-Guenther PhD, Yvonne.Kellar-Guenther@ucdenver.edu
Colorado Clinical and Translational Sciences Institute (CCTSI)
http://cctsi.ucdenver.edu

Expires

6/9/2009

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