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

The summary for the Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.

Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed: The 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 assessment activities including data modeling for a risk-based inspection prioritization and workplan. The funding will catalyze and support the institution's activities that are focused on building a global consensus on criteria for an optimal good manufacturing practice inspection, the core competencies for Inspectors or investigators, and planning, prioritizing and conducting inspections based on well informed risk assessments within the context of the increasingly complex and evolving science and innovation in the manufacturing of pharmaceutical products. Based on such consensus, the institution and its network of NRA Inspectorates will work toward a systems-approach and sustainable alignment across NRA Inspectorates in training inspectors and regulatory experts in best practices for maintaining oversight of pharmaceutical supply chains

Federal Grant Title:	Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed
Federal Agency Name:	Food and Drug Administration (HHS-FDA)
Grant Categories:	Agriculture Consumer Protection Food and Nutrition
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-24-026
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Information not provided
Current Application Deadline:	February 27th, 2024
Original Application Deadline:	February 27th, 2024
Posted Date:	December 21st, 2023
Creation Date:	December 21st, 2023
Archive Date:	March 28th, 2024
Total Program Funding:	$150,000
Maximum Federal Grant Award:	$150,000
Minimum Federal Grant Award:
Expected Number of Awards:	1
Cost Sharing or Matching:	No
Last Updated:	December 21st, 2023

Applicants Eligible for this Grant: Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility: 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 proven record of working with a varied and wide range of NRA inspectorates aiming at harmonizing and better aligning inspection procedures worldwide by developing common standards, practices and approaches in the field of GMP, by providing capacity building opportunities to inspectors, and facilitating cooperation and networking among competent inspectional authorities, regional, and international organizations, thus increasing mutual confidence in the GMP inspectional arena in the field of pharmaceutical products; and 5) have a proven record in the development of competency- and capacity-building activities and programs to build and strengthen skills and expertise of GMP Inspectors and the development of harmonized inspectional procedures. Foreign Institutions Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Grant Announcement Contact: Zahara Graves
Grantor
Work
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