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Scientist working in Lab

GLP/GMP at the University of Maryland, Baltimore

The GLP Quality Management Systems Office assists with compliance to GLP regulations for each organizational unit either directly conducting GLP research or by research units providing support for GLP-related studies.

Each research group conducting GLP-based research or providing services for GLP studies must be approved in advance for each GLP study. The office will assist and ensure the requirements can be met by the investigator’s organization.

Previous GLP Studies at the University of Maryland, Baltimore

The University of Maryland, School of Medicine has had an active GLP program for more than 11 years.  GLP related projects have been quite varied.  For example, some previous studies addressed the efficacy and mechanisms of action of medical countermeasures against radiological threats. These studies resulted in FDA approval of a drug (Neulasta) for the treatment of radiation injury.

Other studies conducted at the University tested heart assist devices to be used in pediatric patients and evaluation of a drug to treat severe hemorrhage and poly-trauma hemorrhagic shock.