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TITLE: ‘Innovation Fundamentals: The Regulatory Environment & FDA in Critical Care”

Jeanne Wright previously worked for Pfizer as a Senior Research Recruiter in the Phase 1 Clinic where she assumed lead role in the collaboration with the study team to influence the design of Phase 1 Unit studies in accordance with FDA IND Regulations to execute first in human clinical protocols, along with marketing and advertisement design and placement for volunteer recruitment.  Her experience at the University of Michigan includes a Research Compliance Specialist Senior at the IRBMED, and currently the Administrative Program Director of the Michigan IND/IDE Investigator Assistance Program (MIAP), Michigan Institute for Clinical and Health Research (MICHR). Jeanne directs the operations and activities of MIAP to support University of Michigan’s faculty investigators engaged in FDA regulated research. The MIAP program provides investigators with comprehensive FDA regulatory assistance that includes support throughout the IND/IDE process lifecycle, including education, consultations, and FDA submissions.