Business Acumen

Applied

Models of Regulatory Support at Academic Medical Centers and Strategies for Collaborating with Industry

Session Leader(s)

• 

  Amanda Parrish, PhD, RAC

  Director of Regulatory Affairs & Quality

Speaker(s)

• 

  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.

 

Learning Objectives:

• Describe the different types of regulatory models used at AMCs.
• Strengthen a regulatory program with limited resources.
• Identify how industry can collaborate with AMCs to reduce hurdles encountered during medical product development.