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Medical Devices and the FDA - Tips for Researchers

GTRC - Office of Industry Engagement

Thursday, January 24, 2013 from 8:30 AM to 12:30 PM (EST)

Medical Devices and the FDA - Tips for Researchers

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Free General Admission Ended Free  

Event Details

Georgia Tech Research Corporation (GTRC) is pleased to present a symposium to provide Georgia Tech faculty, researchers, and students an overview of medical devices that are regulated by the FDA and best practices for conducting research and planning for commercialization. The program include experts in a variety of disciplines related to research and development, FDA regulation, and commercialization. Each session will include time for Q&A.

  • 8:30-9:15 – Keynote speaker, Gary Dykstra
  • 9:15-10:00 – Medical devices, William Kitchens
  • 10:00-10:15 – Break
  • 10:15-11:00 – GMP/GLP compliance, Marie Mathews
  • 11:00-11:45 – Medical device apps, Bradley Thompson
  • 11:45-12:30 – FDA regulatory guidelines, Linda Braddon

Please register so that we can plan for your attendance. We look forward to having you join us for this exciting event! 

 

Symposium Speakers

Gary Dykstra - Mr. Dykstra served in a variety of capacities during his 40 year career with the FDA, with roles including Regional Director, Deputy Associate Commissioner for Regulatory Affairs, and Deputy Director - Surveillance and Compliance for the Center for Veterinary Medicine. His experience enables him to share his insights on the workings of the FDA as well as important aspects that researchers should consider in the course of their work. Dykstra is currently a Professor in the College of Pharmacy at the University of Georgia where the Director of Biomedical Continuing Education and Strategic Planning.

Bill Kitchens - Mr. Kitchens is a Partner in the Food and Drug Practice with Arnall Golden Gregory. He served as the firm’s managing partner from 1996–2008 and has also served as chairman of the Healthcare and Life Sciences Practice. Mr. Kitchens’ practice focuses on food and drug law and government investigations. He advises companies in the food, medical device, pharmaceutical and biotech industries on a wide range of issues, including strategies for obtaining Food and Drug Administration (FDA) approvals of new products, clinical trials, risk management, advertising and labeling, good manufacturing practices and post-approval safety requirements. He also counsels companies about recalls, market withdrawals, crisis management, responding to FDA inspectional observations and warning letters, the defense of anticipated enforcement actions and the negotiation of consent decrees. Mr. Kitchens has published numerous books and articles on food and drug law and regulatory law topics. He is an adjunct professor at Emory University School of Law, where he has taught a course in food and drug law since 1979. He lectures frequently on food and drug law topics, compliance, and trade regulation topics and is routinely invited to speak at industry, government and academic meetings.

Marie Mathews - Ms. Mathews began her career in public health with the U.S. Food and Drug Administration in the Atlanta office in 1990 as an Investigator. In this position she conducted inspections of a wide array of firms, such as medical device, drug manufacturers, and clinical investigators to ensure compliance with FDA regulations. She served on the foreign inspection cadre for performing medical device inspections throughout Europe and Japan in addition to performing domestic work. She also became the district specialist in criminal investigations and built a major medical device prosecution case for the FDA. Ms. Mathews also worked for the Emory University Institutional Review Board where she co-led the team that secured the IRB’s first national accreditation, which the Board received in 2008. She then worked for the CDC as a senior Quality Assurance Specialist in the Division of the Strategic National Stockpile, which is a $3.5 billion inventory of pharmaceuticals and medical supplies to be used for U.S. emergency response needs. In January 2011 she returned to the U.S. FDA as a Compliance Officer. In this position she evaluates and develops cases for enforcement actions or seeks to obtain voluntary compliance through interactions with regulated entities.

Bradley Thompson - Mr. Thompson is shareholder in the law firm of Epstein Becker & Green, P.C. He counsels medical device, drug, and combination product companies on a wide range of FDA regulatory and reimbursement issues. Mr. Thompson leads the Medical Device Regulatory Practice, the Clinical Trials Practice and the Connected Health Practice, and serves on the firm’s Health & Life Sciences Steering Committee. He has served as counsel to AdvaMed and the Continua Health Alliance, as General Counsel to the Combination Products Coalition, mHealth Regulatory Coalition and the CDS Coalition and as General Counsel and Secretary for the Indiana Medical Device Manufacturers Council. Mr. Thompson has taught food & drug law at Indiana University School of Law-Indianapolis and Columbia Law School. He also serves on the editorial boards for Medical Device & Diagnostic Industry (1993-present), Food & Drug Law Journal (2007 – 2010) and BNA’s Medical Device Law & Industry Report (2007-present). He also has served as Co-Chair of the Food & Drug Law Committee in the American Bar Association and of the Medical Device Committee of FDLI. Mr. Thompson has written extensively on the topics of medical device regulation.

Linda Braddon - Dr. Braddon is the Founder and President of Secure Biomed Evaluations, a firm specializing in product development and testing of implantable medical devices. Her team of engineers and product managers provide medical technologies companies with support related to reguatory submissions, quality systems implementation, design and management of non-clinical testing, emerging technology evaluation, and early stage product development. The company, which works with both classic implantables as well as novel materials, is focused on helping medical device manufacturers get their devices to market faster. 

Have questions about Medical Devices and the FDA - Tips for Researchers? Contact GTRC - Office of Industry Engagement

When & Where


GTRI Conference Center - Main Auditorium (http://www.gtri.gatech.edu/conference-center)
250 14th St NW
Atlanta, GA 30318

Thursday, January 24, 2013 from 8:30 AM to 12:30 PM (EST)


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Organiser

GTRC - Office of Industry Engagement

GTRC's Office of Industry Engagement supports industry collaboration and commercialization worldwide. We work together with campus innovators and industry partners to move new technologies and discoveries out of Georgia Tech and into the mainstream of the U.S. economy by promoting partnerships with industry, government, and non-profits; helping transform Georgia Tech’s breakthrough technologies into products; and spurring economic development throughout Georgia and beyond.

Industry Engagement is a one-stop shop for anyone interested in pursuing strategic collaborations through sponsored research, international research, licensing, and new venture agreements.

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