FDA Communication Power Tools

Kwame Ulmer, Ulmer Ventures
February 21, 2018

The US Food and Drug Administration offers a range of mechanisms to communicate with premarket and premarket staff. The timing of communication and best practices to ensure both parties understand each other’s messages is not well understood. Manufacturers regularly under-estimate the time and preparation required for effective communications for premarket applications and postmarket communications.

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About the speaker:

Kwame Ulmer is a asw2qaswqas executive with over fifteen years of experience in government and the private sector. He is currently a regulatory strategy consultant with a focus on MedTech and Venture Capital firms. Mr. Ulmer previously served as Vice President, Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher Corporation Operating Company. Mr. Ulmer, reporting directly to the president, led efforts to accelerate market access through shortened global registrations, improved product quality by process optimization and led activities resulting in best-in-class department engagement scores.

Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA). While at the FDA, he ran operations of a seventy four -person division and has personally evaluated over 1,000 technologies. Mr. Ulmer earned a B.S. in Physics from Lincoln University graduating with honors. He earned an M.S. in Materials Engineering and an MBA from the University of Virginia, where he received the Lion Legacy Award and C. Stewart Sheppard Distinguished Service Award, respectively.

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