Patsy Trisler’s experience in regulatory affairs started with employment at the FDA’s Center for Devices and Radiological Health in 1985. Ms. Trisler began consulting in 1991. She has owned her own consulting firm since 2003. Prior to that she held senior management positions with small to mid-size consultancies and clinical contract research organizations. In those capacities she was the responsible operations manager for regional offices as well as manager of regulatory, quality and clinical projects performed for clients.

Her expertise is in medical device and combination products’ regulatory and clinical affairs: advising on strategy at all stages of new product development and post-marketing activities, and preparing applications for FDA’s review. Ms. Trisler has conducted good clinical practice (GCP) workshops and presented at many regulatory affairs and clinical research conferences on topics related to FDA submissions and interactions.

Ms. Trisler is regulatory affairs certified (RAC) and is a Washington, D.C.-licensed attorney. Prior to her tenure at the FDA, she attained her law degree in a part time program while working at the National Institutes of Health in a microbiology research laboratory. Her undergraduate degree is in biology.