"Obtaining an FDA Investigational Device Exemption - Webinar By GlobalCompliancePanel"
Toll Free Number: 800-447-9407 RAPS Approved Webinar on Obtaining an FDA Investigational Device Exemption Date: Tuesday, November 20, 2012 Time: 10:00 AM PST | 01:00 PM EST Course "Obtaining an FDA Investigational Device Duration: 60 Minutes Exemption" has been pre-approved by RAPS as Instructor: Robert F. Munzner eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion. Location: Online Robert F. Munzner Medical Device Register Now Consultant, Robert Munzner was employed in the FDA Office of Device Evaluation for more than twenty years. As Chief of the Neurological Devices Branch he reviewed and supervised the review of IDE, PMA and 510(k) applications. He also served as Acting Director of the Division of Anesthesiology, Neurology, and Radiology Devices. ...more Overview: Clinical testing and studies of effectiveness are often needed to demonstrate that new medical devices are reasonably safe and effective. The participation of human subjects in these studies often implies some degree of risk and outcomes which are necessarily unpredictable. It is essential, therefore, that the rights, safety, and welfare of the subjects be protected. The instrument by which this is accomplished is the Investigational Device Exemption (IDE). We will discuss here the conditions under which this protection is necessary, the means by which the IDE rules can be met while considering the degree of risk involved, and the means by which an approved IDE can be obtained. Areas Covered in the Session: l Definition of "Medical Device" l Meaning of "Intended Use" l "Research" vs. " Treatment l Institutional Review Boards l 21 CFR 812 l An IDE Without an FDA Application l The Sponsor - Investigator Relationship l Contents of an Application for an IDE l The Investigational Plan l Device "labeling" defined, required l Informed Consent Requirements l Laboratory Data l Time Frame for FDA Response Who Will Benefit: Suggest a Topic l Medical device developers l Physicians conducting More Webinars research l Hospital Administrators l Biomedical Engineers l Biomedical Engineering department chairs Click here to l Students doing human register for this research webinar It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe