Trk 09: Med Devices/InVitro/CombProd [
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10:45am
#134: How Can We Utilize Mobile Health for Better Quality of Life and Medical Economy?
Chair MM
Unit Chief, Division of Regulatory Cooperation, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)
President, Nara Medical University
Hiroshi Hosoi, M.D., Ph.D. is a president of Nara Medical University in Japan. He is a doctor who specializes in Otorhinolaryngology. In 2004, he found a new sound conduction pathway “cartilage conduction,” which is different from the two previously known sound conduction pathways...
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Chairman and Chief Executive Officer, Vital Connect, Inc.
Nersi is Chairman & CEO of VitalConnect, a medical device and healthcare solutions company applying advanced biosensor technology and surrounding data management systems to deliver an innovative platform that enables clinical-grade continuous monitoring of vital signs. He is a veteran...
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Director, Digital Health Division, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical...
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Monday June 27, 2016 10:45am - 12:00pm
103A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm
#242: Regulatory Challenges in the Development of Combination Products Involving Digital Technology
Chair 
Vice President and Head of Regulatory Affairs Americas, Bayer
Todd Paporello is Vice President and Head of Regulatory Affairs Americas at Bayer Pharmaceuticals. Before joining Bayer, he held leadership positions of increasing responsibility within regulatory affairs at Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy (PharmD...
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Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies & standards related to drug product quality, including...
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Director, Digital Health Division, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical...
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General Counsel, Combination Products Coalition, Epstein, Becker and Green P.C.
BRADLEY MERRILL THOMPSON is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Mr. Thompson also advises such companies on the...
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Associate Vice President, Regulatory Affairs - Devices, Sanofi US
Anthony Watson is the Head of Regulatory Affairs - Devices, for Sanofi, in Cambridge, Massachusetts. Before Sanofi, he was the Director of Regulatory Affairs, CMC, Combination Products at Biogen. Prior to Biogen, he was a Division Director responsible for drug delivery devices in...
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Associate Director for Policy, FDA
John Barlow Weiner is the Associate Director for Policy in the Office of Combination Products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA's Office of Chief Counsel and in private practice. He received a BA from Princeton University and a JD with honors...
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Tuesday June 28, 2016 2:00pm - 3:15pm
108A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
