Karen K. Gerlach

Karen K. Gerlach, Ph.D., M.P.H. is a regulatory scientist with years of experience in the public, private, and non-profit sectors. She has experience in all aspects of science from conducting basic laboratory research to applying scientific evidence to advance regulatory decisions and public policy. She has assisted clients and clients’ vendors in the design, implementation, analysis, and reporting of behavioral research efforts in support of regulatory submissions for tobacco harm reduction products. She has also been involved with the design, implementation, and reporting on all aspects of post-marketing surveillance required under Risk Evaluation and Mitigation Strategies (REMS) imposed by the FDA for certain classes of scheduled opioid and sleep medications