Dr. Michael R. Hamrell, RAC, FRAPS, RQAP-GCP is the President of MORIAH Consultants, a Regulatory Affairs and Clinical Research consulting firm located near Los Angeles, CA. Dr. Hamrell has a unique background with over 30 years experience in regulatory affairs, clinical research and drug development with academia, the FDA, NIH and in industry. He also worked for over 5 years at the FDA and 3 years at the NIH in the Division of AIDS, coordinating the development of drugs, biologics and vaccine products for AIDS, oncology and anti-infectives. Dr. Hamrell has dealt with Regulatory Authorities in numerous countries and supervised all aspects of product development and approval.
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.
He has a Ph.D. degree in Pharmacology from the University of Southern
California and a B.S. in Biochemistry from the University of California,
Dr. Hamrell holds an appointment as Adjunct Professor of International Regulatory Sciences at the University of Southern California School of Pharmacy, as Adjunct Associate Professor at the Massachusetts College of Pharmacy & Health Sciences, and as an Instructor at Eastern Michigan University Clinical Research Program.
Dr. Hamrell has received numerous awards for his research, teaching and professional work. He has published numerous papers in pharmacology, regulatory affairs, product development, clinical research, compliance, computers and information systems.
Dr. Hamrell is a Fellow of the Regulatory Affairs Professionals Society (RAPS) and was recently elected as a Fellow of the Association of Clinical Research Professionals (ACRP).
Dr. Hamrell has served on the Editorial Board of Regulatory
Affairs FOCUS, the Drug Informtion Journal, ACRP Journal and Applied Clinical Trials.
He currently serves on the Editorial Board of Applied Clinical Trials,
and is the past Editor-in-Chief of The ACRP Journal Clinical Researcher of the
Drug Information Journal and former Editor-in-Chief of the DIA Forum.
He is also the former Editor-in-Chief of the GCP Q&A Reference Guide published by Barnett International.