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Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01)
The Cooperative Agreement will build upon the extensive experience of an institution with well-established and globally recognized collaboration with inspectorates of National Regulatory Authorities (NRAs) around the globe in support of data-driven and science-based regulatory and public health strategies
and approaches that align with FDA domestic and global priorities to assure a pharmaceutical quality integration of assessment, inspection, policy, and research activities within a pharmaceutical context, including Good Manufacturing Practices (GMP).
The funding will catalyze and support the institution's activities that are focused on consensus around what optimal good manufacturing practices are and the competencies for Inspectors within the context of emerging and increasingly complex science, research and innovation in 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 and among NRA Inspectorates in GMP quality manufacturing.
and approaches that align with FDA domestic and global priorities to assure a pharmaceutical quality integration of assessment, inspection, policy, and research activities within a pharmaceutical context, including Good Manufacturing Practices (GMP).
The funding will catalyze and support the institution's activities that are focused on consensus around what optimal good manufacturing practices are and the competencies for Inspectors within the context of emerging and increasingly complex science, research and innovation in 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 and among NRA Inspectorates in GMP quality manufacturing.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $1,500,000
Office: Food and Drug Administration
Estimated Funding: $1,500,000
Who's Eligible
Obtain Full Opportunity Text:
FULL ANNOUNCEMENT
Additional Information of Eligibility:
Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) OtherRegional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 InstitutionsNon-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:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-18-024.html
Contact:
Agency Email Description:
Work Email
Agency Email:
Date Posted:
2018-06-11
Application Due Date:
Archive Date:
2018-09-12
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