Faculty Directory

Michael Hamrell

Michael Hamrell

Adjunct Lecturer

Michael R. Hamrell, PhD, RAC, FRAPS, RQAP-GCP, CCRA, FACRP is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located in the Central Coast region of California.  He has worked in drug development, clinical research and regulatory affairs for over 30 years.  His is a leading expert in GMP/GLP/GCP compliance and inspection readiness, having conducted audits around the world at clinical sites, contract manufacturers, CROs, vendors, laboratories and IRBs.  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/Toxicology 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 Mann School of Pharmacy International Regulatory Program.  He is also a member of the NCI-Early Phase Development central IRB.

He has published numerous papers in pharmacology, regulatory affairs, medical 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 the founding editor of the DIA Forum and as the Editor-in-Chief of the Drug Information Journal, Editor-in-Chief of ACRP Clinical Researcher and Editor-in-Chief of the GCP Q&A Reference Guide and member of the Editorial Board of DIA Global Forum and Applied Clinical Trials.  He currently serves as a member of the Editorial Board of Therapeutic Innovation and Regulatory Sciences.