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
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
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $150,000
Office: Food and Drug Administration
Estimated Funding: $150,000
Obtain Full Opportunity Text:
https://grants.nih.gov/grants/guide/pa-files/PAR-24-084.html
Additional Information of 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.
Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/pa-files/PAR-24-084.html
Contact:
Agency Email Description:
Work
Agency Email:
Date Posted:
2023-12-21
Application Due Date:
Archive Date:
2024-03-28
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