YPSILANTI ? MichBio announced that Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration will keynote the 2010 MichBio Expo & Conference this October at the Marriott at Eagle Crest in Ypsilanti.
“Dr. Shuren’s visit will be particularly timely as the FDA’s CDRH continues with reviews of pivotal regulatory procedures for one of America’s fastest growing sectors, the medical devices and technology industry. His perspectives on anticipated changes to the 510(k) review process that are likely to be reported in draft form by early fall, will be of great interest to Michigan’s device manufacturers,” said Stephen Rapundalo, PhD, MichBio president and CEO. The Center is responsible for assuring the safety, effectiveness, and quality of medical devices, assuring the safety of radiation-emitting products, and fostering device innovation.
Dr. Shuren first came to the FDA in 1998 and has served in several positions, including the Acting Deputy Commissioner for Policy, Planning, and Budget, Special Counsel to the Principal Deputy Commissioner, Associate Commissioner for Policy and Planning, and Assistant Commissioner for Policy. Dr. Shuren also served as the Director of the Division of Items and Devices, Coverage and Analysis Group at the Centers for Medicare and Medicaid Services, a detailee on the Senate Health, Education, Labor, and Pensions Committee, and as a Staff Volunteer in the National Institutes of Health?s Cognitive Neuroscience Section where he supervised and designed clinical studies on human reasoning. He received his B.S. and M.D. degrees from Northwestern University, completed a medical internship at Beth Israel Hospital in Boston, a neurology residency at Tufts New England Medical Center, a fellowship in behavioral neurology and neuropsychology at the University of Florida, and received his J.D. from the University of Michigan. Dr. Shuren was an Assistant Professor in the Department of Neurology at the University of Cincinnati College of Medicine where he led two active memory disorders clinics and implemented a research program in Alzheimer’s disease and disorders of higher cognitive function.
“The 2010 MichBio Expo & Conference is shaping up to be an outstanding event,” according to Rapundalo. ?In addition to our keynote speaker, the two-day event will feature a breakfast policy forum with Michigan’s gubernatorial candidates, business partnering sessions with large pharma and device OEMs, our Emerging Biosciences Showcase of start-up companies seeking investment funding, facility tours of area bioscience companies, and track sessions in medical devices and diagnostics, pharma, emerging business and bio-based technologies. We expect to match or exceed last year?s over 500 attendees for what surely will be a dynamic opportunity for networking, education and business development. This is an event not to be missed.”
For more information, click on MichBio.Org
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