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Keynote AddressAnthony Orosz
Assistant Center Director, Pharmaceuticals, Health and Chemicals Center of Excellence and Expertise, United States Customs and Border Protection (CBP)
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CTPAT Program Overview
in CTPAT
risk importers and
Increasing benefits for CBP and traders
CTPAT, Trade Compliance, PGAs and MRA and AEOsTrusted traders receive facilitated
benefits globally
CTPAT, Trade Compliance and PGAsTrusted traders receive benefits at
CTPAT Traders are members ofCBP’s voluntary supplychain security programSecurity
Partnership
GlobalReach
CTPAT, Trade ComplianceTraders are ISA compliant and meet CTPAT security requirementsCompliance
Non-participant
But consistently low
exporters
partner government agencies
Trade SecurityTrade Security refers to the security of supply chains relative to current and emergent threats.
• CBP partners with industry and foreign governments, and uses a risk-based approach to identify threats at the earliest point possible and before they reach U.S. Ports of Entry (POE).
• CTPAT processes 54% of all imports into the United States. Industry Partners in CTPAT experience decreased supply chain disruptions, reduced and expedited inspections, and decreased wait times at land border POEs.
Trade compliance refers to an importer’s ability to meet regulatory requirements imposed by CBP and other government entities.
• CTPAT currently maintains the Importer Self Assessment (ISA) Program to allow approved members to ensure their own compliance with regulatory requirements.
• After the Trusted Trader Pilot assesses benefits, the office will transition existing ISA members to the Trade Compliance portion of CTPAT.
Trade Compliance
CTPAT is a voluntary public-private sector partnership program to strengthen the security of international supply chains and the U.S. Border, and increase trade compliance.
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§ Created in the aftermath of 9/11 in response to an ongoing threat
§ Voluntary government-business program to build cooperative relationships that strengthen and improve overall international supply chain and US border security
§ First worldwide supply chain security program
§ Requires businesses to ensure the integrity of their security practices and verify the security guidelines of their business partners within the supply chain
§ Reduced number of CBP examinations§ Front of line inspections§ Shorter wait times at the border§ Assignment of a Supply Chain Security Specialist to
the company§ Access to Free and Secure Trade (FAST) Lanes at
land borders§ CTPAT web-based Portal system and a library of
training materials§ Eligibility for other U.S. Government pilot programs
§ Tier 1—Certified Memberü Risk Score reductions
§ Tier 2—Validated Memberü MSC have been metü Significant Risk Score reductions
§ Tier 3—Validated Memberü Security measures exceed MSC and best
practices have been adoptedü Most significant Risk Score reductions
§ CTPAT is part of a layered law enforcement strategy
Trade Security
National Targeting
Center
24 Hour Trade Act
Intelligence
Container Security Initiative
NII TechnologyAutomated TargetingSystem
CTPAT
Impetus for Creation Piece of the Puzzle
CTPAT Tiers (Importers & Exporters) Benefits
As a supply chain security program, CTPAT requires participants to adhere to Minimum Security Criteria (MSC) and in exchange participants within the three different tiers experience benefits throughout the import process.
CTPAT Security
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200+ minimum standards for membership
Over 30,000 validations conducted
Validation site visits conducted in 109 countries
11 Mutual Recognition Arrangements
11,400+ Certified Partners
CTPAT provides a variety of benefits to CBP that allow the Agency to more effectively carry out its mission:
Since CTPAT was established in November 2001, the Program has increased supply chain security and improved the safety of cargo at all points along the international supply chain.
Increased Security
Greater Efficiency
Shared Responsibility
§ Seeks to decrease supply chain attacks that may disrupt the flow of international commerce and pose a national security or safety threat to domestic industry and the public.
§ 54.1% of all imports (by value) into the U.S. are CTPAT Certified, importers make up the bulk of members at 37% and by taking advantage of program benefits cargo moves more effectively into the U.S.
§ Promotes shared responsibility from the trade community
§ Promotes coordination and taking a proactive stance with industry to increase supply chain security as a voluntary program
CTPAT Security – Impact Today
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Long-Term Expectations
§ Applicants must apply online via the CTPAT web portal
§ Eligibility requirements must be met before applicant’s company information is inputted
§ Each applicant must complete a security profile
§ CTPAT has to review and either approve or reject within 90 days
§ If the security profile is approved, CTPAT must conduct on on-site validation within one year
§ CTPAT must ensure applicant complies with the program’s security criteria
§ Utilize verification process to develop a strong working relationship with the applicant
Eligibility Certification Validation Verification
CTPAT has established a rigorous application process for vetting candidates to the program in order to ensure security and compliance measures are met and followed.
§ Validation of reported supply chain security and alignment to guidelines
§ Performed within 1 year from certification for all CTPAT participants
§ Every 1-2 years continue to review forms, sign-in sheets and checklists
§ Failure to show procedures are being followed can jeopardize future re-validation
§ Expect to see improved procedures the longer participants are a member
§ More stringent on requirements than original validation
§ Re-validation occurs every 3-4 years§ A re-verification report will be written and
participants have 90 days to respond by updating their actions in the web portal
§ Participants are required to assess the level of risk business partners bring into the supply chain, which can be based on the recommended Five Step Risk Assessment Process
§ Failure to respond timely can result in suspension or removal from the program
Periodic Re-Validation
Initial Validation Process
CTPAT Validations & Verification
CTPAT Application Process
CTPAT Security – Application Process
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I. Business Partner Security Requirements
Requires that Members to select, screen, and monitor their business partners’ compliances with MSC.
II. Physical Access Controls
Requires the positive identification of all employees, visitors, and vendors at all points of entry.
III. Information Technology Security
Requires documented policies for user ID, passwords, email, internet access, hardware & software security.
IV. Personnel Security
Requires employees and contractors to complete screening, pre-employment verification, background checks, and comply with U.S. immigration laws.
V. Procedural Security
Requires Members to document processes relevant to transportation, handling, and storage of cargo.
VI. Security Training and Threat Awareness
Requires specific trainings to ensure that employees are able to identify, prevent, and respond to a security threat.
VII. Physical Security
Requires Members to deny unauthorized access to facilities and protect personnel and property via surveillance guidance.
VIII. Container Security
Requires a 7-point inspection on all empty containers and storage with a specific documentation by a qualified employee.
Applicable MSC Entity Groups
Minimum Security Criteria
The MSC are layered, cross-departmental security standards co-created by CBP and the trade community and spread across eight categories applicable to thirteen business entity types.
Sea Carriers
Marine Port Authority & Terminal Operators
Air Carriers
Customs Brokers
Long Haul Carriers
Foreign Manufacturers
Highway Carriers
ImportersExporters
Consolidators Rail Carriers
Third Party Logistics Providers (3PLs)
A core set of requirements across the 8 MSC Criteria apply to all partners, but custom criteria also apply to the 12 entity groups. Partners must adhere to all core and custom criteria.
CTPAT Security – Current Minimum Security Criteria (MSC)
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§MR means that the security requirements/standards of the industry partnership program, as well as its verification procedures, are the same or compatible with those of the potential MR partner.
§MR is a long term goal
§Customs, AEO Programs & Trade Community must realize the time, effort and resources that goes into achieving MR.
International Strategy
Mutual Recognition
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§ Commitment to MRAs link various international industry partnership programs together creating a unified and sustainable end-to-end security posture that facilitates safe and efficient global trade
§ Support of organizations such as the World Customs Organization (WCO) and the Asia-Pacific Economic Cooperation (APEC) working to improve the security and integrity requirements of their membership
Mexico
Canada
European Union
Japan
Jordan
New Zealand
South Korea
Israel
Dominican Republic Taiwan
Singapore
CTPAT’s partnerships with international trade communities and authorities strengthens its role as an integral part of global supply chain security.
11 Mutual Recognition Arrangements:
International Strategy
Global Reach – MRAs and SAFE Framework Pillars
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Uruguay
Peru
China
Brazil India
5 Joint Work Plans towards MRA
Australia
International Strategy
Joint Work Plans
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Mutual Recognition
Communication§ Internally – Upper Managements & Field Level§ Externally – Trade Community
o Face to face meetings & updated information on internet§ Communication between MRA Partners
o Updates; POC changes; Maintenance of MRA
Automation§ C-TPATs Portal system was created in 2007 and is currently being
upgraded
Working with Partner Government Agencies (PGA)§ Many PGAs have similar programs that overlap§ Reduce redundancies§ Provide additional benefits
MRA LESSONS LEARNED
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Trusted Trader Strategy§ Integrates the C-TPAT and ISA
programs into a consolidated program that includes both supply chain security and trade compliance – AEO standard
§ Supports a scalable program, integrated with PGAs and aligned with leading AEO programs
§ Moves toward whole of government approach to supply chain security via PGA engagement
in CTPAT
risk importers and
Increasing benefits for CBP and traders
CTPAT, Trade Compliance, PGAs and MRA and AEOsTrusted traders receive facilitated
benefits globally
CTPAT, Trade Compliance and PGAsTrusted traders receive benefits at
CTPAT Traders are members ofCBP’s voluntary supplychain security programSecurity
Partnership
GlobalReach
CTPAT, Trade ComplianceTraders are ISA compliant and meet CTPAT security requirementsCompliance
Non-participant
But consistently low
exporters
partner government agencies
Trusted Trader
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Trusted Trader PilotTrusted Trader
üCreated a roadmap of the future vision for the Trusted Trader strategyüWorking closely with 7 pilot participants to develop and test benefitsüDeveloping a unified database to catalog and evaluate pilot benefits
Phase II: FY 2016 – FY 2018
q Prioritize and evaluate impact of benefits with pilot participantsq Establish trade compliance standard of operation and implement new benefitsq Operationalize program and transition ISA members to Trade Complianceq Engage international partners and MRA-AEOs
Phased Rollout: Begin FY 2019
Phase I: FY 2014 – FY 2016üSelected 9 pilot participants from 56 applicantsüValidated pilot incentives for inclusion in initial offering
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What are Centers of Excellence and Expertise?
§ Industry-focused and account-based points of virtual processing for post-release trade activities
§ Aligned by 10 key industry sectors in strategic locations
§ Consolidate existing expertise and build industry-specific education to authoritatively facilitate trade
§ Provide national overview of accounts (importers) to identify areas for further facilitation or corrective action
§ Serve as a resource to the broader trade community and to CBP’s U.S. government partners
Centers
Centers will be integrated into every facet of the trade process; from pre-arrival to final liquidation
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§ Centers§ Company imports into
60 ports of entry§ Single Center conducts
entry summary reviews
• Objective:– Focus on industry-specific
issues– Facilitation– Reduce transaction costs– Increase compliance– Increase uniformity of
treatment• Past processing:
– Company imports into 60 ports of entry
– 60 ports conduct entry summary reviews
Why Centers?
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Apparel, Footwear & Textiles
Electronics
Machinery
Petroleum, Natural Gas & Minerals
Agriculture & Prepared Products
Consumer Products & Mass Merchandising
Base Metals Automotive & Aerospace
Industrial & Manufacturing Materials
Pharmaceuticals, Health & Chemicals
Centers of Excellence and Expertise
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Goals of Centers
1. Increase industry-based knowledge within CBP- Advance cross-education to raise industry knowledge- Engage industry groups and key stakeholders- Identify industry trends and commercial threats
2. Facilitate legitimate trade through effective risk segmentation- Utilize account based methods to process trade- Expand partnerships - move more importers to trusted trader status- Develop and implement comprehensive strategies to manage risk
3. Enhance enforcement and address industry risks- Leverage industry to identify issues of mutual interest to provide CBP with
targeting, enforcement, and/or intelligence information- Coordinate enforcement efforts by industry to address unique risks
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Is The Pharmaceutical Supply Chain Secure?Moderatorä Nina Heinz, Global Head of Network & Quality, DHL Global Forwarding
Panelistsä Tom Grubb, Global Head of Pharmaceuticals and Healthcare, American Airlinesä Jennifer Haigh, Aviation Security Consultant
ä David A. Komjati, Director of CoE Transportation and Distribution, Merckä Anthony Orosz, Assistant Center Director, Pharmaceuticals, Health and Chemicals CoE & Expertise, US CBP
ä Alessandro Rivolta, Project Manager, Alha Groupä Paul Rodwell, International Business Development, OnAsset Intelligence
nallian data sharing for business collaboration
Collaborative Data Sharing for Virtually Integrating fragmented pharma supply
chainsHow source-controlled granular data sharing combined with open architectures
enable high-performance logistics networks, sustainably
Jean Verheyen, CEO, Nallian
nallian data sharing for business collaboration
Connect, Collaborate, ModernizeA Practitioner’s View
Jean Verheyen, CEO, Nallian
nallian
making the world operate as one
Nallian offers a cloud-based data sharing platform that helps communities of business partners
collaborate and operate as one
our mission
nallian
AIRLINES AIRPORT AUTHORITIES
DECLARANTS, CUSTOMS,CONTROL ORGANISATIONS
SHIPPERS TRUCKINGCOMPANIES
At Brussels Airport, the BRUcloud communityknows about more things faster
nallian
TANK STORAGE
CLEANING STATIONSSHIPPERS TANK
TRANSPORT
Creating process visibility in chemical tank transportby sharing cleaning certificates improves product quality
ECD
CH
HC
H
HC
OH
nallian
Modal shift to ocean for low/mid value products
Pharma Air Cargo
Estimated biopharma air cargo spend by 2020
$93bn
Compound annual growth rate in 2006-2016
3.4%
Overall industry growth rate in same period
1.4%
Annual product loss due to temperature excursions
$15bn
Estimated sales of counterfeit pharmaceuticals
$217bn
Challenges
Can you prove air cargo is superior?
Can you offer full traceability of your products?
nallian
• Many systems and connection partners
• Many data types, formats and standards
• Important data is late or absent
• Cross-enterprise process optimization is hard
• Creating a single version of truth is hard
• Trust: today’s partners are tomorrow’s competitors
• Profit from new technologies: IoT, block-chain, data sharing, AI …
• Keeping it open: avoid building a bigger silo
• Mimic the speed of evolution of B2C
Common challenges
connect collaborate modernize• Connect any data source in real time• Publish data only once
• Keep control over who sees your data• Flexible and granular data sharing
• A modular and open architecture• Interoperable with other platforms
data process digitization
nallian
• Use the data you already have today
• Look to visionary partners in your current network
• Form a coalition of the willing
• Look for a quick win (examples)
• Attract more members: more data, more apps, more value, repeat
• Agree on a community governance model to get everyone on board
Best practices
connect collaborate
network community
Example: Global Pharma Tracker
modernize
opportunitiesfuture• Predictive quality assurance
• Global end-to-end product traceability
• Counterfeit avoidance by origin tracking
nallian
Conclusion
Building a virtually integrated pharma supply chain
• Connect any data source in real time
• Publish data only once
• Keep control over who sees your data• Flexible and granular data sharing
• A modular and open architecture• Interoperable with other platforms
• A pragmatic approach• Applications that add real value
• Community based on trust• Clear governance model
Connected Cargo to Transform the Pharmaceutical Digital Supply Chain?
Adam CrossnoCEO, OnAsset Intelligence
Adjusting to Challenging Trade Lanes –A Carrier Perspective
Ibrahim SpahiCargo Product Development, Turkish Airlines
© 2016 Turkish Cargo All Rights Reserved
Adjusting To Challenging Trade Lanes A Carrier Perspective12th World Cargo Symposium – Dallas TK Pharma
13-15 March, 2018
Table of Contents
01INTRODUCTION
04FUTURE
• Facts & Figures
• Our Vision for Istanbul New Airport
03CHALLENGES
• A Carrier Perspective
• CASE 1: Lack of Facility Investments
• CASE 2: Critical Risk Points in HUB Operation
• CASE 3: Challenges with Stakeholders
• CASE 4: Regional Conflicts
• Our Goals and Objective forTK Pharma Product
• Q&A
PHARMA TRADE LANES
• Global Pharma Origins & Destinations
02
Turkish Airlines Timeline
1933
1936
1972 2000 2004
1995 2000
First international cargo was carried in 1936
2 DC-10 aircraft joined the fleet
Turkish Cargo brand was established within Turkish
Airlines
2010
First A 330F joined thefleet
2 C-47 cargo aircraft joined the fleet
3 B727-200 aircrafts were converted to cargo planes. First A310F was operated
1130k tons of cargo
2017
Turkish Airlines was foundedin 1933.
In the meantime, Turkish Airlines carried small packages
and post
Turkish Cargo’s Growth
198 236 313 386 465 565 666 717 88911301.0% 1.2% 1.2%
1.6% 1.8% 2.… 2.2% 2.4% 2.6%3.0%
0.0%
1.0%
2.0%
3.0%
4.0%
0
500
1000
1500
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Thou
sand
Ton
nes
Carried Tonnage & Sales Market Share Development
Tonnage Carried TK Market Share
Turkish Cargo achieved above 25% yoy growth on tonnagein 2017, Turkish Cargo carried 1 Million and 130 thousandtonnes of cargo by the end of 2017.
Global Ranking
1
1
4
253 International DestinationsMore international destinations than any other in the world
More countries than any other in the world121 Countries
304 Destinations4th largest network in the world
Achievements & Awards
2015 LogitransInternational Air Cargo
Winner
2015 Payload Asia Combination Carrier of
the Year
2016 Success in Logistics Awards
Logistics Project of the Year
2016 LogitransInternational Air Cargo
Winner
2017 Stat Times International Award for Excellence in Air Cargo
Winner
2017 Payload Asia Overall Carrier of the
Year Winner
Turkish Airlines Passenger Network
America EuropeFar East
Middle EastAfrica
Country City
Europe 43 113
Far East 22 36
Middle East 13 34
Africa 34 52
America 8 17
11417 36
3452
17%
AirportDomestic Destinatons
83%
AirportInternational Destinatons
FEB 2018
121 Country
301 CityAirport
International Destinations
We fly to 304 airports in 121 countries.Phuket flights started on 17 th of July which is the 36 th airport in
Far East.
Phuket flights started.4 frequencies to Phuket every week with Turkish Airlines.
3 0 4Airport Total
Airport Domestic Destinations
5 1 2 5 3
51Turkey
Turkish Airlines Freighter Network
65 Country81 City
81Total Airport
America Europe Far East
Middle EastAfricaCountry City
Europe 23 27
Far East 10 12
Middle East 14 19
Africa 13 14
America 5 9
FE23%
AF14%
ME19%
US6%
EU38%
279 12
1914
Istanbul New Airport Cargo Facility
Phase 12 Million
Tons
Phase 22 Million
Tons
All Phases4 Million
TonsIntermodal
TransportationRoad-Sea-
Railway
E-Commerce HUB
Express & PER Cargo Center
Increased Slot Connection to
More Than 300 Stations
Free TradeZone
Opportunity
Phase 1 2.5 Million
Tons
All Phases6 Million
Tons
Phase 2 3.5 Million
Tons
Turkish Cargo
Capacity
Total Cargo
Village Capacity
Our Vision for Istanbul New Airport
• Highest service level and standards• Increasing capacity in current market and existing in new potential markets• Seeking for the pursuit of service excellency together with all stakeholders• Increasing customer satisfaction and loyalty• Becoming one of the Top 5 Airline companies
Major Challenges in Pharma Trade Lanes- a Carrier Perspective
Low
Medium
High
ORG
DST
Manufacturer Road Feeder
ForwardingAgent
Road Feeder GHA/RAMP
GHA/RAMP RegulatoryAuthority
Road Feeder
ForwardingAgent
Road Feeder Consignee
TransferIST HUB
RAMPGHARAMP
AlternativeMode
Case Studies for Best Practice
Case 1: Lack of Facility InvestmentsCase 2: Critical Risk Points in HUB OperationCase 3: Challenges with StakeholdersCase 4: Regional Conflicts
Case 1: Lack of Facility Investments
71.000 m²Total Floor Area Used (Land and Air Side)
67.000 m²Total Construction Area
43.000 m²Closed Warehouse Area
0°C/+4°C : 556 m² / 7 Storage Rooms+ 2°C/+8°C : 872 m² / 9 Storage Rooms
+ 15°C/+25°C : 861 m² / 9 Storage Rooms-15°C/-20°C : 393 m² / 5 Storage Rooms
DedicatedPharma Rooms
DedicatedAcceptanceGate
CCTV 24/7
SatelliteWarehouse
ULD Storage
Active Containers
Thermal Dollies
Single Use Thermal Covers
Case 2: Critical Risk Points in HUB Operation
TK Pharma Care Team
Internal & External
Audits
Pharma Training Program
90minutes
QRT
IST HUB
Plug in & Dry IceReplacement
Case 3: Challenges with Stakeholders
SLAs & SOPs(Forwarders)
Quality Agrement & Service Provider Assessment (Road Feeder)Quality Agreement & Service Provider Assessment (Road Feeder)
Case 3: Challenges with Stakeholders
Quality Agreement (GHA)Service Provider Assessment (GHA)
Illustrated ONLY
Illustrated ONLY
Illustrated ONLYIllustrated ONLY
Illustrated ONLY
Illustrated ONLY
Case 4: Regional Conflicts
• Various Certification Programs• Weather/Climate Conditions• Local Time Differences• Airport Authority Regulations• Limited Number of Pharma Certified Stakeholders
Average High/Low Temperature: Istanbul
Our Goals and Objective for TK Pharma Product
• Highest service level and standards in Pharma operations
• Pursuit of service excellency together with all stakeholders
• Increasing customer satisfaction and loyalty
• Consulting services from independent Pharma Experts
• Controlling the risks by a cloud platform
• Becoming World’s Top 3 preferred carriers in Air Pharma Industry
• Re-certification