Sponsored by The Northwestern University's Feinberg School of Medicine and the Northwestern University Clinical and Translational Sciences (NUCATS) Institute in collaboration with the Association of Clinical Research Professionals (ACRP). Michael Marcarelli serves as Director, Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health. He has over 20 years of FDA regulatory experience in the premarket and postmarket oversight of drugs and medical devices. Michael has given many presntations on FDA-regulated clinical trials and published several articles on device clinical trials. He currently serves on the Regulatory Affairs Professional Society (RAPS) Editorial Board. Michael received his undergraduate degree from Northeastern University in Boston and his Doctor of Pharmacy from the University of Arkansas as Little Rock. He recently completed his academic requirements for a MS Regulatory Affairs degree from Johns Hopkins University, Baltimore, MD. The FDA is Coming! presented by Michael E. Marcarelli, PharmD, MS, Director, Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health This lecture will describe how FDA selects sites for inspection, what they look at when conducting inspections and how to address FDA observations
1. Describe FDA’s oversight of Clinical Trials
2. Develop a strategy for preparing to be inspected by FDA
3. Learn how to resolve FDA concerns regarding clinical trial conduct
For more information on this event to to be included on our mailing list for future activities, please email us at nucats-ed@northwestern.edu. For questions during the conference on Friday, May 16, 2008, please call 312-926-2383.
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