Combination Product Regulatory Policy Advisor
U.S. Food and Drug Administration
Silver Spring, Maryland
Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). In this role, she is responsible for engaging in development of CDER's policies related to combination product review and regulation, including activities such as guidance development, facilitating coordination with the FDA's Office of Combination Products, CBER and CDRH, and representing CDER in cross-center combination product working groups. Kristina originally joined FDA in 2003 as a device reviewer in CDRH. She later joined the Office of Combination Products and spent several years there prior to joining CDER in 2014. She holds a B.S. in Biology from Shippensburg University, and a Ph.D. in tumor biology from Georgetown University.
Wednesday, November 4, 2020
2:00 PM – 3:00 PM ET