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21 CFR Part 58 U.S. Food & Drug Administration (FDA) Code of Regulations for Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies.
Director, Regulatory & Scientific Affairs Regulatory & Scientific Affairs (RSA) provides regulatory guidance for nonclinical studies which include infectious disease related projects to develop vaccines, therapeutics and diagnostics. The incumbent advises the university administration and principal investigators (PI) on scientific and regulatory policy involving strategy in the design and conduct of regulated and non-regulated studies to support development of products designed for the treatment and prevention of human disease for study in clinical trials and may be candidates for licensure. Involved is the design and conduct of both in vitro and in vivo GLP studies that meet scientific and regulatory requirements. The studies are designed to demonstrate vaccine potency, efficacy and safety to prevent disease, implementation of therapeutics to treat infectious disease, definition of antigens that stimulate protective immunity, diagnostic tests to improve clinical medicine, and translation of scientific discovery in the regulatory pathway to product development. Effort is focused on collaborative and programmatic research involving the cooperation of multiple scientific disciplines working together in an environment disciplined by regulatory principles and compliance. (UTMB JD A0401)
Director, Regulatory Operations The incumbent provides strategic, regulatory, and educational support and expert advice regarding compliance with federal and state requirements related to regulated nonclinical studies at UTMB; provides oversight for regulatory operations of the Institutional Office of Regulated Nonclinical Studies including the Quality Assurance Unit and Good Laboratory Practices (GLP) archive; approves institutional policies and Standard Operating Procedures (SOPs) governing regulatory operations for nonclinical studies. (UTMB JD A0946)
Good Laboratory Practices (GLP): As stated in 21 CFR Part 58 Subpart A58.1(a), Nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed. Procedures for regulated studies follow GLP guidelines.
Principal Investigator

the lead person, whom has the requisite expertise, to oversee a particular project. He or she assumes the full responsibility for the programmatic, administrative, ethical, legal, technical, operational and fiscal aspects for the management of the project including adherence to all requirements of the funding entity.

Quality Assurance Unit (QAU) Any person or organizational element, except the Study Director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies. The QAU shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with regulations in this part. For any given study, the QAU shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. (21 CFR Part 58 Subpart A58.3(l) and Subpart B58.35) Testing Facility Management associated with the Institution include Executive Vice President, Provost, and Director, RSA.
Regulatory Science The science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. (www.fda.gov)
Study Director (associated with GLP study): The individual responsible for the overall conduct of a nonclinical laboratory study. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. (21 CFR Part 58 Subpart A58.3(m) and Subpart B58.33) The ORNcS Study Director provides support for both regulated and non-regulated scientific studies regarding regulatory oversight, summaries and protocols. The ORNcS Study Director will work with the PI, Director RSA and technical staff associated with given study.
Study Protocol For GLP studies, each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. (21 CFR Part 58 Subpart G 58.120) A Regulated Study Protocol is written by the Study Director under the guidelines provided by the PI and Director, RSA and approved by same.
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