Regulatory Affairs

Allison Kumar, CEO of Arina Consulting, LLC leads the Regulatory Affairs Core (RAC) in conjunction with ICON and other regulatory consultants, with responsibility for overseeing collaboration with FDA, and by and between drug manufacturers and TRACK-TBI NET. The RAC maintains and updates timelines for progress toward regulatory milestones and prepares for and leads all discussions with FDA about protocol development and amendments. The RAC will also take a lead role, in collaboration with the Outcomes Core and BAC, and drug manufacturers/sponsors, to produce study reports formatted for FDA review.