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Dianne Raccasi
Principal Consultant at Parexel


Diane has over 11 years experience with FDA, including tenure as a Senior Microbiology BLA Reviewer for CDER/OPQ/OPF/Division of Microbiology Assessment. Diane was also an ORA carrying out the implementation of injunctions, seizure warrants and participation in criminal cases, as well as lecturing on cross-contamination and microbiology. Before the FDA, she held roles relating to clinical trial testing, assay development, quality systems, and validation of analytical methods. She also spent four years working as an Enteric Epidemiologist characterizing disease trends on bacterial and viral surveillance data and coordinating outbreaks between state and federal agencies.

Agenda Sessions

  • Clinical and R&D Compliance