Speakers

Kristina Lauritsen, PhD serves as the Combination Product Regulatory Advisor and Product Jurisdiction Officer (PJO) within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER’s policies related to combination product review and regulation. Kristina originally joined FDA in 2003 as a device reviewer in CDRH, moved to the Office of Combination Products in 2007, and then to CDER in 2014. She holds a B.S. in Biology from Shippensburg University, and a Ph.D. in Tumor Biology from Georgetown University.