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). 
Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in drug development, clinical research and regulatory affairs for over 20 years. He has worked in pharmaceuticals, contract research, government, and biotech industries, in domestic and international regulatory affairs and clinical research. Dr. Hamrell also worked in the Division of AIDS in NIAID at the National Institutes of Health, and as a reviewer in the Center for Drug Evaluation & Research at the Food and Drug Administration (FDA), in the Divisions of Antiviral Drug Products, Oncology Drug Products, and Bioequivalence.
Dr. Hamrell spent a number of years doing basic research, first as a Research Fellow at Duke University and later as an Assistant Professor of Pharmacology at the McGill University Cancer Center. Dr. Hamrell has a Ph.D. degree in Pharmacology from the University of Southern California and a B.S. in Biochemistry from the University of California, Los Angeles. Dr. Hamrell has received numerous awards for his research, teaching and professional work and is recognized in Who's Who. Dr. Hamrell also holds an appointment as Adjunct Professor of Molecular Pharmacology and Toxicology at the University of Southern California School of Pharmacy, as Adjunct Associate Professor at the Massachusetts College of Pharmacy & Health Sciences and as Adjunct Associate Professor at the College of Health Sciences at Touro University International and the School of Nursing at the University of North Carolina Wilmington. He has published numerous papers in pharmacology, regulatory affairs, product development, clinical research, computers and information systems. Dr Hamrell served as a founding Editorial Board member for Applied Clinical Trials and RA FOCUS, as a member of the Editorial Board of the DIA Journal and serves on the Editorial Board of Applied Clinical Trials, Clinical Trials Advisor, the DIA Forum and is the Editor-in-Chief of the Drug Information Journal. GCPs and Monitoring and Oversight of Clinical Trials presented by Michael R. Hamrell, Ph.D., President, MORIAH Consultants In this era of striving to meet strategic goals, clinical studies are being conducted across broad geographic areas. Many investigational sites have become highly specialized. The implementation of the ICH GCP has led to a common focus for GCP activities but cultural and regional differences still exist in their implementation.
1. What are the current site compliance issues in the conduct of clinical trials?
2. Learn how to relate regional differences to GCP compliance
3. Understand the role of government audit in addressing clinical research compliance
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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