Karen K. Church, PhD, RAC, has been a regulatory professional for over 30 years and appears in “Who’s Who of American Women” the “International Who’s Who,” and Cambridge “Who’s Who”. She has served as President and Secretary of Drug Information Association (DIA) Board of Directors, on the DIA Training Course and Strategic Planning Committees, and as Chair for the Steering Committee for the Americas. Karen helped develop and serves as instructor for the DIA Regulatory Affairs I, Regulatory Affairs II, and Fundamentals of Clinical Research Monitoring (formerly Entry Level Clinical Research Associate (CRA) training courses, and has received the DIA Outstanding Service Award.

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.