Instructors
Erin Keegan, MS
Combination Product Policy Analyst, Food and Drug Administration, United States
Erin Keegan has worked at the FDA since 2014. For the first five years of her FDA career she was a Lead Reviewer in CDRH's Office of Health Technology 5 where she primarily reviewed premarket submissions for neurostimulation systems for neurological disorders. In her current role as a CDRH Product Jurisdiction Officer, she works with internal and external stakeholders to provide guidance on combination product policy as well as the overall classification and jurisdiction of medical products. Over the past year, she has also provided support on CDRH's EUA activities. Erin received her Bachelors and Masters Degrees in Biomedical Engineering from the University of Rochester in Rochester, NY.
Sarah Mollo, PhD, RAC, PhD, RAC
Combination Product Policy Analyst, OPEQ, CDRH, FDA, United States
Sarah Mollo serves as a Combination Product Policy Analyst and Product Jurisdiction Officer in CDRH. Prior to joining the CDRH combination product policy team, Sarah was a lead reviewer and biocompatibility consultant for general hospital devices branch for 3 years before serving the team lead for injection products within OHT3/OPEQ/CDRH. Sarah earned her bachelor’s in Microbiology and Cell Science from the University of Florida and her doctorate in Immunology from the University of Alabama at Birmingham. Prior to joining the FDA she was a post-doc at Harvard University.
Kristina Lauritsen, PhD
Combination Products Regulatory Policy Advisor, OEP, CDER, FDA, United States
Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor 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, 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. Prior to joining CDER in 2014, she spent four years in the Center for Devices and Radiological Health, followed by seven years in the Office of Combination Products. She holds a B.S. in Biology from Shippensburg University.