Center of Excellence and Expertise Tradewatch 2011 February 17, 2011

Presenter’s Name June 17, 2003 Official Use Only 2 CEE Overview  Background  Goals of the CEE  Positive Outcomes of the CEE Concept  For CBP  For the Trade

Presenter’s Name June 17, 2003 Official Use Only 3 Raise the Level of Pharmaceutical Expertise in the Agency  Industry-led training  Industry sponsored training in May  On-going informal training from Trade on business process  Trade training on identifying counterfeits  Outreach and Training to key CBP employees in field  Regular communication to internal and external stakeholders

Presenter’s Name June 17, 2003 Official Use Only 4 Improve Facilitation of Legitimate Pharmaceutical Trade  Industry specific policy  Request for information => reduces interruptions and costs  Cargo holds/detentions/releases => consistency, reduces costs  Limited lab sampling => consistency, reduces costs  Entry process for placebos => consistency, aligns with FDA  Value adjustments at account level => reduces costs  Recordkeeping => streamlines process  Use of bonds => consistency, reduces costs  Monitoring port adherence to policy => uniformity/consistency  Joint trusted partner program with FDA => reduces costs

Presenter’s Name June 17, 2003 Official Use Only 5 Increase the Detection and Interdiction of Counterfeit/Substandard Drugs and Deter Repeat Violators  In-depth risk analysis to improve targeting  Focus operations on express and international mail facilities  Coordinate closely with ICE and FDA  Collaborate with Trade  Raise port awareness of trends  Provide field with templates and how-to’s  Share best practices with foreign governments  Develop a progressive discipline scheme to deter repeat violators

Presenter’s Name June 17, 2003 Official Use Only 6 Positive Outcomes for Trade  Centralizes a point of contact-phone, , web site postings  us at:  Phone:  Web:  Allows for regular forum to exchange views  Provides consistency in the import process  Reduces transactional costs and improves release times  Enhances benefits for trusted partners that are tailored to industry  Improves the protection of intellectual property  Creates a forum for focused discussion with FDA

Presenter’s Name June 17, 2003 Official Use Only 7 Positive Outcomes for CBP  Brings together a variety of skill sets into a narrow focus  Import Specialists, National Account Manager, Analyst, Chemist, Counsel  Provides an increase in industry knowledge – facilitation, enforcement, uniformity  Establishes positive relationship with Trade with ongoing dialogue  Provides a centralized point of contact and source of industry information for CBP field employees