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  1. Office of Global Regulatory Operations and Policy

OIP Strategy Map (Accessible Text Version)

OIP Strategy Map (Accessible Text Version)

GO Vision:  A global product safety net: all food is safe; all medical products are safe and effective; and the public health is advanced and protected

OIP Mission: OIP helps to build and lead FDA’s mission globally

ApproachesLeveraging and CollaboratingAnalyzing and Utilizing Global Data to Inform FDA’s Decisions and Actions
OutcomesResult 1:
Advance Diplomacy
Result 2: Strengthen Global Regulatory SystemsResult 3:
Collect and Share Intelligence and Information
Result 4:
Utilize Global Data Networks and Analytics
▪ Convergent Standards and Best Practices (1.1)
▪ Better Regulatory Decisions through Global Coalitions and Mutual Reliance (1.2)
▪ Increased Scale and Reach through Leveraged Resources of Government, Industry, and Private Third Parties (1.3)
▪ Increased Industry Knowledge of GxP (2.1)
▪ Improved Industry and Regulator Understanding of Regulatory Science and FDA Requirements (2.2)
▪ Enhanced Surveillance of Safety and Quality Issues (2.3)
▪ Competent Regulatory Inspectors Worldwide (2.4)
▪ Competent Regulatory Laboratories Worldwide (2.5)
▪ Increased FDA Knowledge of Global Landscape Including Regulatory Systems Context (3.1)
▪ Accurate Identification of Supply Chain Elements (3.2)
▪ Improved Reliability and Accuracy of Data (3.3)
▪ Potential Threats Identified Faster through Real-Time
Information Sharing (4.1)
▪ Resources Allocated and Deployed Based on Risk (4.2)
Efforts▪ Furtherance of Public Health- Trade Nexus
▪ International Arrangements
▪ Bilateral and Multilateral Partnerships and Networks
▪ Multi-Sector Collaborations
▪ Outreach, Education, Competency Building, and Cooperative Agreements
▪ Advocacy for Public Health Regulatory Issues
▪ Collection, Analysis, and Dissemination of Timely Information
▪ Inspections and Investigations
▪ Information Sharing Platforms
▪ Catalyst for Global Connectivity

Continuous Alignment with ORA and Center Priorities and Implementation of Legislative Mandates

Result 5: Achieving Excellence

OPERATIONAL EXCELLENCE (5.1)
Strategic Resource Management
WORKFORCE EXCELLENCE (5.2)
Skilled and Knowledgeable Workforce
ORGANIZATIONAL EXCELLENCE (5.3)
▪ Managing for Results
▪ Public Health Outcome Measurement
▪ Budget Development and Execution
▪ Staffing and Contracts
▪ Technology and Data Systems
▪ Optimize Synergies in GO
▪ Hiring and Retention
▪ Leadership Development
▪ Proactive Management and Succession Planning
▪ Cultural and Linguistic Competency
▪ Learning Organization
▪ Quality Management System
▪ Project Management
▪ Communication and Transparency
▪ Property Management