Strengthening Global Competency and Capacity for Pharmaceutical Inspections

The summary for the Strengthening Global Competency and Capacity for Pharmaceutical Inspections 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 for Pharmaceutical Inspections: 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 for Pharmaceutical Inspections
Federal Agency Name: Food and Drug Administration (HHS-FDA)
Grant Categories: Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-23-022
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Information not provided
Current Application Deadline: June 20th, 2023
Original Application Deadline: June 20th, 2023
Posted Date: April 14th, 2023
Creation Date: April 14th, 2023
Archive Date: July 20th, 2023
Total Program Funding:
Maximum Federal Grant Award: $450,000
Minimum Federal Grant Award: $50,000
Expected Number of Awards:
Cost Sharing or Matching: No
Last Updated: April 14th, 2023
Applicants Eligible for this Grant
Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility
Eligible Organizations 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.
Link to Full Grant Announcement
FULL ANNOUNCEMENT
Grant Announcement Contact
Shashi Malhotra
Grants Management Specialist
Phone 2404027592
[email protected]
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