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Speaker: Sousan S. Altaie, Ph.D.
Scientific Policy Advisor
Office of In-Vitro Diagnostics
FDA
February 5th, 2009 at 2:00 EST.
What is the pre–Investigational
Device Exemption (IDE) Program?
* A free consultative service by the
review staff at the FDA
* A non binding agreement between FDA &
sponsor
* Results in a well prepared submission
* Results in a shortened review time
* Results in saving money and resources for
both the industry and the FDA
FDA Guidance and Best Practices for Going
Through the Pre-IDE Process
* Recognizing the importance of quality
pre-IDE submissions
* Introduction to the pre-IDE process
* Protocol proposal by sponsor
o Intended use statements
o Objectives of the clinical study
o Study design and testing
procedures
o Study results
* Review by FDA review team
* Meeting with sponsor
* Written feedback to sponsor
* Summary and examples
* Question & answer period
Speaker Biography:
Dr. Sousan Altaie is the Scientific Policy
Advisor for the Office of In Vitro Diagnostic
Devices and is actively working as a member
of the Global Harmonization Task Force (GHTF)
and International Standards Organization
(ISO) working groups. She was appointed the
CDRH Critical Path Coordinator in 2004 and is
actively involved in the Agency's Critical
Path initiative. She is the author of many
peer reviewed articles.
How it Works
All registrants will be emailed a
powerpoint presentation to follow along with
during the call. The conference call access
number and password will be emailed to
registrants 1 hour prior to the start of the
meeting.
Cost
$395 Includes the 90 minute recording in mp3. format and presentation slides | 
