Ms Carol H. Danielson, Dr PH, RAC has provided regulatory expertise and leadership for more than twenty five 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.

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 pharmaceuticals, contract research, government and biotech industries, in domestic and international regulatory affairs and clinical research. He also worked in the Division of AIDS in NIAID at NIH and as a reviewer at CDER at the FDA. Dr. Hamrell has published numerous papers in pharmacology, regulatory affairs, product development, clinical research, computers and information systems.