Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed

Due: Feb 27, 2024

$150,000

DescriptionThe Cooperative Agreement will build upon the extensive experience of an institution with well-established and globally recognized expertise and quality standards for drug inspectorates of National Regulatory Authorities (NRAs) around the globe in support of data-driven and science-based regulatory public health strategies and approaches. The organization's best practices should align with the FDA domestic and global priority of assuring of the integration of pharmaceutical good manufacturing practice (GMP) inspections and risk a...

Estimated Total Program Funding$150,000Expected Number of Awards1Award Ceiling$150,000

Eligible Applicants- Others

Additional Eligibility Information

Only the following organization is eligible to apply: The Pharmaceutical Inspection Cooperation Scheme (PIC/S) The applicant must: 1) have strong institutional linkages with NRA Inspectorates around the globe; 2) have extensive knowledge of procedures and systems across the globe in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use; 3) be a leader in international development, implementation, and maintenance of harmonized GMP standards and quality systems; and 4) have a...

Funding TypeCooperative AgreementCategories of Funding Activity- Agriculture- Consumer Protection- Food and NutritionOpportunity TypeDiscretionary

Grantor Contact InformationWorkGrantor Emailzahara.graves@fda.hhs.govOther Grantor InformaitonZahara Graves Grantor

Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed

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