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International Regulatory Capacity BuildingGlobal Curriculum Project
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Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad
2012 Institute of Medicine Report
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• Product safety through GMPs, GAPS• Staff development and training • Monitoring products using laboratories• Inspection and surveillance throughout the supply chain • Risk assessment, analysis, and management • Emergency response
Core Elements of a Food Regulatory System
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1. Adherence to international standards
2. Supply chain problems3. Infrastructure deficits4. Lack of/ confusing regulatory laws
Neglected Unequally applied Non existent product liability laws
Nine Problems Facing Product Safety Systems in Developing Countries
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5. Regulatory responsibilities scattered across agencies6. Poor public health/ food safety surveillance systems7. Poor communication
Within a regulatory authority Across government agencies that share regulatory
responsibilities Between government and the regulated industry Between government and the public With counterpart agencies in other countries
8. Lack of accountability/ public will
Nine Problems Facing Product Safety Systems in Developing Countries
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9. Regulatory workforceInsufficientRetention problems, low payLack of training / lack of
academic curricula Poor moraleCorruption is a
cause and effectUndue political influenceFragmentation
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• Adherence to International Standards• Controlling Supply Chains• Infrastructure Deficits• Strong Legal Foundation• Workforce• Fragmentation• Surveillance• Communication• Political Will• Enterprise Risk Management
IOM Recommendations
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FDA Office of International Programs - led effort
• Training is the first step• Build a global regulatory curriculum • Needs/ gap analysis tools• Donor agencies assurance• World Bank – Global Food Safety Partnership
FSMA International Regulatory Capacity Building
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FDA Office of International Programs
Global Curriculum Project
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• Food & medical products
• Training government regulators
Global Curriculum Project
Scope
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Global Curriculum Project - Phase I
By October 2014
Define the minimal core competencies of a regulatory professional
Develop a curriculum framework for educating and training the regulatory workforce
Develop a gap assessment tool to be used by low-middle income countries
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Competency-Based Curriculum Development
1
Create Competenc
y Framework
2
Identify Competencie
s
3
Create Curriculum Framework
4
Develop Curricula
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Categories of Minimal Competencies
Core Professional
5
General Regulatory
11
Food Technical 35
Medical Products Technical
43
Competencies
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Activities
Expert Panel assembled
Competencies - first cut by panel
Validation using broad international group – survey open now: http://research.zarca.com/k/SsTTXYsVUTsPsPsP
Second cut by panel, curriculum framework, assessment tool – meeting in D.C. Sept. 2014
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Phase II – Next Steps
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