Join your regulatory colleagues from across the Washington, DC/Baltimore area for an evening of learning and networking with a representative from the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Office of Invitro Diagnostic Products. This event is sponsored by the RAPS DC/Baltimore Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. Attendees of this meeting are eligible for 1.5 RAC recertification points.
The presentation by Donald J. St. Pierre, Associate Director for Policy and Operations in the Office of In Vitro Diagnostic Device Evaluation and Safety, will review recent activities at FDA’s Center for Devices and Radiological Health (CDRH), with a special emphasis on IVDs. The presentation will focus on providing guidance to industry on regulations governing both the pre- and postmarket lifecycle aspects of medical devices and radiological products. In his premarket remarks, St. Pierre will highlight the relationship between CDRH’s current activities and the new user fee goals established by the Food and Drug Administration Amendments Act of 2007. He also will provide an update on the center’s postmarket transformation efforts. Following his presentation, St. Pierre plans an interactive discussion with participants on how to get the most out of interactions with CDRH.
A light meal is provided for all meeting registrants.
Speaker: Donald J. St. Pierre, Associate Director, Policy and Operations in OIVD; Center for Devices and Radiological Health (CDRH)
Donald J. St.Pierre is Associate Director for Policy and Operations in FDA’s Center for Devices and Radiological Health’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). Previously, he has served as Acting Associate Center Director for Postmarket Transformation, Deputy Director for New Device Evaluation in OIVD, and Branch Chief of the Office of Device Evalution’s (ODE) Urology Branch in the Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiogical Devices. St Pierre joined the agency as an engineer testing medical devices in the field engineering laboratory before moving to ODE as a reviewer. He graduated with honors with a BS in engineering science and mechanics from The Pennsylvania State University.
Date/Time: Wednesday, 21 May 2008
5:30 pm Registration Opens
5:30–6:30 pm Registration, Networking & Dinner
6:30–8:00 pm Speaker Presentation and Q&A Session
Location: RAPS Training Center
5635 Fishers Lane, Suite #550
Rockville, MD 20852
Directions can be found online, or call +1 301 770 2920 ext. 200
Registration fees: RAPS members: $25; Non-members: $35 - Register today
Local Contact: Rita Hoffman, +1 240 276 0179
RAPS Contact: Wesley Carr, +1 301 770 2920