Regulatory Specialist for the Office of Translational Alliances and Coordination
Dr. Sasiela is the Regulatory Specialist for the Office of Translational Alliances and Coordination (OTAC, http://bit.ly/callNHLBIotac) of the National Heart, Lung, and Blood Institute (NHLBI). In this role she helps NHLBI-funded investigators (academic and small businesses) understand and navigate the US biomedical regulatory pathway through educational events and one-on-one consultation. Prior to joining the NHLBI, Chris’ regulatory experience includes working in the Office of Biotechnology Products at the FDA, and as Director of Regulatory Affairs and Services at a contracting company. She earned a Bachelor’s degree in Chemistry from Whittier College; a Ph.D. in Pharmaceutical Science from the University of Maryland Baltimore; and holds a Regulatory Affairs Certification (US) through the Regulatory Affairs Professional Society.
In this session attendees will learn how to develop a preliminary regulatory path for their biomedical technology and integrate that knowledge into their SBIR/STTR application by answering three questions: Which branch/division within the FDA will review my technology? What is the expected regulatory pathway for my technology? What regulatory uncertainties/challenges can I foresee for my […]