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Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will be organizing a RAPS pre-approved webinar on the topic, “Obtaining an FDA Investigational Device Exemption” on November 20. This webinar earns up to 1.0 RAC credits towards a participant's RAC recertification upon full completion. The speaker of this 60-minute webinar will be Robert F. Munzner, a consultant on FDA premarket procedures. ----------------------------------------------------------------------------------------------------------------- Description:This webinar is about the ways of obtaining an Investigational Device Exemption (IDE). An IDE is an instrument through which the safety of subjects who undergo clinical trials for new drugs and other medical products is ensured. When subjects become part of a clinical trial, they are said to necessarily be at some degree of risk, given that the product is being tested for the first time on these subjects. These studies are done to ensure that medical devices that enter the market later are safe. In order to ensure safety at the clinical testing and studies phase, the IDE is implemented, so that subjects are safe. This is an important protection for the subjects on the one hand, and for the safety of the device, on the other. This webinar will offer ways by which a medical device or related company that carries out clinical trials and studies can safety put an IDE in place. It will dwell on the details of 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. The language employed for these trials calls for a lot of interpretation. The nuances of terminologies such as “medical device”, “intended use”, “Institutional Review Board (IRB)”,“sponsor”,“investigator”, and "informed consent” are explained. Another important area this webinar covers is a situation where the person carrying out the research also happens to be the sponsor of the research. Any person or organization carrying out a research involving human subjects and not complying with the prescribed FDA regulations is guilty of “misbranding”, which carries a fine and a punishment. ----------------------------------------------------------------------------------------------------------------- When:November 20, 10:00 AM PDT 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: 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. He has written numerous articles concerning medical devices regulation, including a column in the IEEE Engineering in Medicine and Biology Magazine. He earned a Ph.D. in Biomedical Engineering at the University of Virginia and is Post-Doctoral Fellow of The Johns Hopkins School of Medicine. He presently serves as a consultant to medical device developers seeking advice concerning FDA premarket procedures. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o Medical device developers o Physicians conducting research o Hospital Administrators o Biomedical Engineers o Biomedical Engineering department chairs o Students doing human research ---------------------------------------------------------------------------------------------------------------- Duration: 60 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact webinars@globalcompliancepanel.com Phone: 800-447-9407 AMAZINES.COM
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online Training, FDA Device Exemption, Investigational Device Exemption, IDE, Institutional Review Board, IRB, IDE rules,
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