The director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, Alberto Gutierrez, PhD, will present a regulatory update via a webcast, sponsored by IVD Technology, this month. The presentation will be followed by a live question and answer session with attendees.
Gutierrez, who has been with the Office of IVD Device Evaluation and Safety since 2000, will explore a range of topics relevant to regulatory personnel and other members of the IVD industry. In particular, he will discuss various action items that have been initiated in the wake of a review of the agency's programs and the science that supports them. The Center Science Council, Innovation Pathway 2.0 and the triage pilot program are among the topics that will be addressed. Gutierrez also will provide an overview of recent guidance documentation published by FDA.
The one-hour webcast, part of the IVDT Education Lecture series, is scheduled for August 24, 2012, at 10 AM Pacific/1 PM Eastern. Register to attend here.