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Business Acumen
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Amanda Parrish, PhD, RAC
Director of Regulatory Affairs & Quality
Inna Strakovsky, MRA, RAC
Associate Director, Regulatory Affairs
University of Pennsylvania (Div of Translational Medicine and Human Genetics)
The models of AMC regulatory support range from teams of individuals to one-person efforts that can be a free resource or a for-cost system to reduce the hurdles academic researchers face without seeking outside regulatory resources. This session will describe the benefits and pitfalls of these models, which will assist participants with addressing challenges within their own organization. In addition, AMC regulatory groups, small and large, often work with academic and industry partners to bring investigational products to trial and beyond. This session will highlight ways that regulatory bodies can work together to address challenges and streamline medical product development programs at AMCs.