Nanotechnology & Nanomedicine: Regulatory Safety Assessment in Product Development

Date: 03/19/2014
Time: 6:00 pm – 7:00 pm
Location: 111 Snell Library
Speaker: Wendy Sanhai, PhD. MBA, President, Innovative Strategic Solutions, LLC

Nanotechnology & Nanomedicine: Regulatory Safety Assessment in Product Development

This talk will introduce regulatory safety assessment in product development from the perspective of the Food and Drug Administration (FDA). Examples will be drawn from first-hand experience with the design and implementation of public-private partnerships involving clinical and translational studies.

Dr Sanhai has 7 years experience at the FDA, most recently serving as Senior Scientific Advisor to the Office of the Commissioner. Dr. Sanhai has led the development, implementation, and management of dozens of scientific initiatives and strategic programs and alliances under FDA’s public health mission. She has also designed, negotiated, and implemented more than 100 public-private partnerships involving clinical- and translational-studies, producing know-how, best practices, predictive tools, and guidances to inform regulatory and R&D decisions toward more efficient medical product development and patient care. She currently serves as President at Innovative Strategic Solutions, LLC.