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PharmaceuticalsThank you to our Sponsor

WELCOMENina Heinz

Global Head of Network & Quality, DHL Global Forwarding

Keynote AddressAnthony Orosz

Assistant Center Director, Pharmaceuticals, Health and Chemicals Center of Excellence and Expertise, United States Customs and Border Protection (CBP)

CBP’s Supply Chain Security Initiatives

March 2018

5

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.

6

§ 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

7

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

8

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

9

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)

10

Supply Chain

11

§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

12

§ 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

13

Uruguay

Peru

China

Brazil India

5 Joint Work Plans towards MRA

Australia

International Strategy

Joint Work Plans

14

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

15

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

16

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

17

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

18

§ 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?

19

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

20

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

20

21

Anthony Orosz

Assistant Director, Pharmaceutical Health and Chemical CEE

[email protected]

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

Increased Automation and Digitization in the Pharmaceutical Supply Chain

Jean VerheyenCEO, Nallian

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 data sharing for business collaboration

Who is 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

Are you ready to connect, collaborate and modernize?

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

World Pharma Air Trade Lane – Origin Country

WACD

World Pharma Air Trade Lane – Destination Country

WACD

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 1: Lack of Facility Investments

Temperature & Humidity Mapping

Telemetry System

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 2: Critical Risk Points in HUB Operation

IATA Check List Qualified Envirotainer Provider

NOTOC

Case 2: Critical Risk Points in HUB Operation

TK Pharma Instructions

TK Pharma Risk Assessment

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 3: Challenges with Stakeholders

Station Capability Matrix (GHA)

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

Closing RemarksNina Heinz

Global Head of Network & Quality, DHL Global Forwarding

Networking LunchTrinity Exhibit Hall

PharmaceuticalsThank you to our Sponsor