The purpose of Core D is to provide an infrastructure of regulatory and technical expertise to maintain and manage consistent compliance with the regulatory requirements for all projects in the PREVENT Program. The Core includes two separate but complementary components: (i) oversight of the preclinical work required to support a successful IND, including interactions with the FDA and (ii) management and oversight of regulatory compliance, training, and implementation of a pre-Phase 1 clinical trial. The Core will manage, track, develop, and provide coordinated responses to all regulatory submissions and Agency interactions. This will include the transition from pre-GMP to cGMP drug substance and drug product manufacture, pilot and GLP preclinical toxicology, strategic interactions with external regulatory agencies, and IND development and submissions, with a focus on regulatory training and education and the goal of standardizing the Program's regulatory practices. The Core will also provide an overall Quality Management Plan, and implement and monitor quality control and quality assurance activities, as needed, throughout all program projects and cores. The Core will coordinate and direct all required self-monitoring activities and will serve as a central document control repository.

Public Health Relevance

PREVENT Program Regulatory Affairs Core (Core D) will ensure that the overall PREVENT program complies with regulatory requirements. The core will oversee activities relating to product manufacture regulations, as well as clinical trial regulations.

Agency
National Institute of Health (NIH)
Type
Research Program--Cooperative Agreements (U19)
Project #
1U19AI113182-01
Application #
8769377
Study Section
Special Emphasis Panel (ZAI1)
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of Louisville
Department
Type
DUNS #
City
Louisville
State
KY
Country
United States
Zip Code
40202