Helen Y. Saccone, PharmD, MSEL FDA

CAPTAIN Helen Saccone serves as a Senior Advisor within CDER’s Office of Strategic Programs.   CAPT Saccone was part of the inaugural team that initiated the US-EU Mutual Reliance Initiative in 2014, that led the negotiations and implementation of the US-EU Mutual Recognition Agreement for the FDA.

CAPT Saccone joined FDA in 2008 as a Program Management Officer within CDER’s Office of Compliance, then served as the Associate Director of Global Policy within FDA’s Office of Commissioner.  Prior to joining FDA, she worked as a pharmacy inspector for the DC Department of Health and a Senior Manager of Education at the American Pharmacists Association.

CDR Saccone received her Doctorate of Pharmacy from Rutgers University and was commissioned into the US Public Health Service in 2009.