Introduction to Medical Device Research and Making the Risk Determination, June 17, 2009

Join Public Responsibility in Medicine and Research (PRIM&R)
for a device-specific webinar, designed by the Division of Bioresearch Monitoring,
Office of Compliance, Center for Devices and Radiological Health,
Food and Drug Administration.

NEW registration rates range from $165 for individuals to $350 for groups of any size.
Plus, special rates are available for PRIM&R members.

This 90-minute webinar, Introduction to Medical Device Research and Making the Risk Determination, will be held Wednesday, June 17, 2009, at 1:00 PM ET. The content of this webinar should appeal to those working with IRBs/HRPPs and/or those engaged in conducting device research.

Participants will learn more about…

• Introduction to investigational device exemption (IDE)
• The IRB significant risk vs. nonsignificant risk determination
• Tools to use to find approved labeling information for devices cleared via 510(k) and PMA
  (Premarket Approval)

Faculty

Fabienne Santel, MD
Dr. Fabienne Santel is the medical officer at the Division of Bioresearch Monitoring at the FDA Center for Devices and Radiological Health (CDRH). Dr. Santel is the primary clinical contact within the Division and supports Division staff in the reviewing complaints and inspection reports. Most often, these reports reveal deliberate or repeated noncompliance with regulations governing investigational device research or associated human subject protection. Dr. Santel is also a clinical reviewer at CDRH Office of Device Evaluation where she provides clinical reviews to ensure the quality, reliability, and integrity of data submitted in support of investigational and marketing applications (IDEs, PMAs, 510(k)s, and HDEs). Dr. Santel has experience as a practicing physician, academic researcher, and regulatory official.

Marian Serge, RN
Marian Serge is a registered nurse with past experience as a research coordinator in Department of Clinics, Wake Forest University School of Medicine; a clinical research associate in the Institute of Neurological Disorders and Stroke at the National Institutes of Health (NIH); and as a project officer and a regulatory affairs specialist in the Division of AIDS, National Institute of Allergy and Infectious Diseases at the NIH. She began her career at the FDA in the Center for Devices and Radiological Health in 1997. Ms. Serge is a nurse consultant and peer review expert in human subject protections in the Division of Bioresearch Monitoring, Office of Compliance. She has attended numerous PRIM&R conferences both as a faculty member and as a participant.

Who should attend?

Those working with IRBs/HRPPs, IRB chairs, administrators, staff, and members, as well as institutional officials/signatory officials, researchers, industry representatives working with device investigations, and those engaged in conducting device research will all find this webinar beneficial.

For more information, please visit www.primr.org.
Questions? Call Anne Meade at 617.423.4112, ext. 14, or e-mail ameade@primr.org.