speaker-info

Chris Sasiela, PhD, RAC

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.

My Sessions

FDA Regulatory Basics for Small Businesses

Miro Room

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 […]

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