January 09, 2012 — Coral Gables — With faculty at the University of Miami receiving more than $350 million in sponsored grants and contracts in last year’s extremely competitive funding period, a ranking as the top school in the state in U.S.News & World Report, and an increasingly complex web of regulations and guidelines for researchers to navigate, University of Miami leadership has created the new Office of Regulatory Support and Quality Assurance to serve the expanding needs of the research community.
Regulatory support and quality assurance are key components of any research infrastructure and conform with the Food and Drug Administration’s (FDA) current thinking about the need to implement quality systems.
The University-wide office will provide quality assurance auditing; risk-based good clinical practice monitoring; education, training, and mentorship programs; regulatory support for following local, state, and federal requirements; assistance with investigational new drug applications and investigational device exemptions; and help when preparing for national and international audits.
The office is led by John Newcomer, senior associate dean for clinical research and professor of psychiatry and behavioral sciences, and Johanna Stamates, executive director of regulatory support and quality assurance.
“Our comprehensive quality improvement process engages our expert faculty and leadership in the oversight of quality assurance and quality control,” explained Newcomer.
The newly created office guides investigators through the many steps in the lifecycle for research involving IND applications and IDEs, and assists with submissions to the FDA. The regulatory support team collaborates with other deans and institutional officials at UM.
To reach the office, contact Stamates at 305-243-4538 or .(JavaScript must be enabled to view this email address), or visit uresearch.miami.edu/rsqa.
