Iraq Deployment with the Coalition Provisional Authority

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Iraq Deployment with the Coalition Provisional
Authority

• LCDR Alicia M. Mozzachio
• U.S. Public Health Service
• U.S. FDA
• mozzachioa_at_cder.fda.gov

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Destination Baghdad, Iraq
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(No Transcript)
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Living Conditions
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Transportation
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Emergency Procurement

• List of 205 emergency medications identified
• List sourced out to approximately 25 different
  distributors throughout the world
• US
• Canada
• SW Asia
• Europe

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Money Transfers/Bank Runs...13 Million!
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Emergency Procurement Distribution Issues

• Prior policy
• Ministerial Order
• Delivery to Baghdad Warehouse
• Delivery to Governorates

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REGULATORY ISSUES

• All drug products should be registered
• with the Iraqi Ministry of Health
• Registration includes filing of applications
  
• to include clinical data
• U.S. FDA representative sent to provide
• guidance in revising the regulations

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INITIAL ASSESSMENT

• Drug Registration Regulations were not
• completely transparent to the
• pharmaceutical industry
• Kimadia was continuing to select their
• manufacturer of choice
• MOH continues to test every lot of every
• drug product imported into Iraq

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PROBLEMS ENCOUNTERED

• Initial resistance from the Drug Registration
• Team
• Work schedules
• Opening lines of communication between
• related departments within the MOH
• Lack of modern technology to streamline
• the registration process
• Implementation

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ACCOMPLISHMENTS

• A collaborative effort between CPA and the
• Iraqi MOH resulted in the final draft Drug
• Registration Regulations being submitted to
• the Minister for approval

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ACCOMPLISHMENTS

• A collaborative effort between CPA and the
• Iraqi MOH resulted in the final draft Drug
• Registration Regulations being submitted to
• the Minister for approval
• Opened communications between several
• MOH departments to promote the importation
• of safe and effective drugs

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ACCOMPLISHMENTS

• A collaborative effort between CPA and the
• Iraqi MOH resulted in the final draft Drug
• Registration Regulations being submitted to
• the Minister for approval
• Opened communications between several
• MOH departments to promote the importation
• of safe and effective drugs
• FDA formal presentations provided new
• perspectives for regulatory authority

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Friends along the way