Presentations from Meetings

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Presentations from 2006 Educational Conference -
IVD Focus Meeting
September 14 & 15, 2006

Presentations from the 33rd Annual Meeting, April 20-21, 2006:

Speaker	Topic(s)
Steve Gutman, M.D., FDA	OIVD - Update on a Work in Progress
Hira Nakhasi, Ph.D., FDA	CBER Update
Jonathan Kahan, J.D., Hogan & Hartson, LLP	FDA/IVD Industry Overview
Robert Yocher, RAC, M.H.Sc., Genzyme Corp.	The Co-Development of Drugs and Diagnostics: An In Vitro Diagnostic and Laboratory Perspective
Carol Benson, FDA, And Marina V. Kondratovich, FDA	CLIA Waiver Guidance
Fred Lasky, Ph.D., Genzyme Corp.	Equivalent Quality Control (EQC) CLIA'88
Carolyn Albertson, Abbott	International Update - China
Susumu Nozawa, Becton Dickinson	Pharmaceutical Affairs Law Reform in Japan
Bill McLain, Keystone Regulatory Services	Risk Management - It's more than just an FMEA
Don St. Pierre, FDA	Patient Safety- Pre/Postmarket Balance
Joe Kegelman, Dade Behring	IVD Instruments & Cyber-security
John D. Boselli, PE, BD Diagnostics, and Linette Asay , BD Diagnostics	Electronic Records: Our transition, a multi year journey with great promise
Sousan Altaie, Ph.D. FDA	CDRH Electronic Submissions (CeSub) Turbo 510(k) for In Vitro Diagnostic Devices

Presentations from FDA - Industry IVD Roundtable Meeting May 11, 2006: