Carol H. Danielson, MS, DrPH, RAC

Dr. Carol H. Danielson manages and serves as President of her own Regulatory, Clinical and Quality consulting firm, Regulatory Advantage International LLC based in Tucson, Arizona. She has provided regulatory expertise and leadership for more than 30 years for drugs, biologics and medical devices from discovery through post-marketing. Her areas of specialization include regulatory strategy and submissions, clinical affairs and compliance, and quality assurance and control. Her background includes both extensive “hands on” experience and corporate level strategy activities from partnering due diligence to serving as an expert witness in the drug development process. She has been pivotal in the marketing approval of numerous pharma products, has submitted and maintained over 40 INDs, has served as lead for over 120 FDA meetings and as US Agent for several foreign firms in Asia and the European Union.
Dr. Danielson’s prior industry experience includes senior positions as Director of Regulatory Compliance and Quality Assurance for ALZA Corporation, Vice President of Regulatory Affairs for Biocryst Pharmaceuticals, Vice President for Regulatory, Quality, and Facilities for Viral Antigens, Head of Regulatory Affairs and Quality Assurance for Colgate, Senior Vice President of Clinical and Regulatory for ImRx Therapeutics, Senior Vice President of Regulatory Affairs for MediQuest Therapeutics and CEO, President, and Regulatory Expert for Scarless Laboratories.
Dr. Danielson previously served on the Board of Directors for the Arizona Biotechnology Organization, the Advisory Board for the Clinical Research Program at Pima College and is an adjunct professor in clinical and regulatory affairs. She is a member of the scientific review team for the California Institute of Regenerative Medicine and serves as instructor and chairperson for the editorial board for the DIA training courses as well as conducting regulatory affairs training courses through her own consultancy. She was the recipient of DIA’s 2011 award for Outstanding Contribution to Science and Medicine. Dr. Danielson has an MS in Biology from Samford University and a Doctorate in Public Health from the University of Alabama.

MICHAEL R. HAMRELL, Ph.D., RAC, FRAPS, RQAP-GCP, CCRA

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 30 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 Instructor at Eastern Michigan University Clinical Research Program and as Adjunct Professor at the Massachusetts College of Pharmacy & Health Sciences.
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 the founding editor of the DIA Forum and as the Editor-in-Chief of the Drug Information Journal and Editor-in-Chief of the GCP Q&A Reference Guide. He currently serves as a member of the Editorial Board of DIA Global Forum, Applied Clinical Trials, ACRP ClinicalResearcher.