Iata Ceiv

CEIV Workshop
Bogotá, May 29, 2019

CEIV Introduction,
Overview & Next
Step
Ronald Schaefer
Senior Principal
Ronald SCHAEFER
Senior Principal, Consulting
IATA
[email protected]
3
Aim of the presentation
• Understand the risks and the potential gaps along the cool chain and live animal supply
chain
• Learn how IATA’s standards improve the handling of pharmaceutical cargo
• Introduce and provide an update of IATA’s CEIV Pharma Program:
• Introduce IATA’s CEIV Fresh Program:
• Introduce IATA’s CEIV Live Animals Program:
• Seek your input and constructive feedback

4
IATA Competition Law Compliance
Follow the prepared agenda.
Do not discuss:
• Pricing, including fares, service charges, commissions, etc.

• Bids on contracts or allocation of customers
• Geographic/Product market allocations and marketing plans, including
• Expanding or withdrawing from markets
• Group boycotts
• Your commercial relations with agents, airlines or other third parties
• Any discussion aimed at influencing the independent business decisions of your competitors
You will be asked to leave the meeting, and the meeting may be terminated, if the above-mentioned
discussions occur.
Remember: All discussions count, even informal ones outside the meeting
5
Content Page
1.0 Introduction: CEIV Introduction, Overview & Next Step 6

2.0 Standards + Regulations: The nature of the industry requires strong cooperation and 11
IATA as a standard setting organization
3.0 CEIV Pharma is a concerted effort to improve the level of competency, operational 38
and technical preparedness
4.0 CEIV Fresh is a concerted effort to improve the level of competency, operational and 106
technical preparedness
5.0 CEIV Live Animals is a concerted effort to meet environmental demands that impact 151
animal’s welfare and comfort
6.0 CEIV approach, governance, and organization: A partnership model and approach 186
tailored to the needs of the different stakeholders in the value chain with qualified
experts
6
Content
1.0 Introduction: CEIV Introduction, Overview & Next Step

2.0 Standards + Regulations: The nature of the industry requires strong cooperation and
IATA as a standard setting organization
3.0 CEIV Pharma is a concerted effort to improve the level of competency, operational
4.0 CEIV Fresh is a concerted effort to improve the level of competency, operational and
5.0 CEIV Live Animals is a concerted effort to meet environmental demands that impact
animal’s welfare and comfort
6.0 CEIV approach, governance, and organization: A partnership model and approach
experts
7
What is CEIV?
8
Industry Leverage of Quality & Excellence
9
How can it be implemented?
10
Industry Leverage of Quality & Excellence
11
Content
1.0 Introduction: CEIV Introduction, Overview & Next Step

2.0 Standards + Regulations: The nature of the industry requires strong
cooperation and IATA as a standard setting organization
3.0 CEIV Pharma is a concerted effort to improve the level of competency, operational
4.0 CEIV Live Animals is a concerted effort to improve the level of competency,
operational and technical preparedness
5.0 CEIV Fresh is a concerted effort to improve the level of competency, operational and
experts
experts
12
IATA is a Standard Setting Organization
Implementation and dissemination of standards driven by industry
Step 1: Implementation Step 2: Dissemination
Industry feedback driving improvements:

• Need for standardization in safety, Support Adoption
security, operations, e.g. the handling of
pharmaceutical products in air cargo
environment Prove Concept
• Need to enhance partnership and
communication
• Need to ensure appropriate training in Develop
the supply chain Standards
The industry usually asks IATA to address

their needs to ensure compliance and quality services
13
How are standards developed?
Cargo
• Cargo Committee Committee (CC)
• Reports to the Board of Governors
• Develops cargo strategy, positions and plans
• Cargo Procedures Conferences Management Group Cargo Procedures

• Supports Cargo Committee strategy Conferences Management
• Prioritizes, assigns and monitors the activities of Cargo Group (CPCMG)
Services/Agency Conferences
• Cargo Services/Agency Conferences

Cargo Services Cargo Agency
• Cargo Services Conference (CSC) & Cargo Agency
Conference Conference (CAC)
Conference (CAC) develop standards with anti-trust
(CSC)
immunity
14
IATA ensures that both safety and animal welfare are addressed in all regulatory issues
pertaining to transportation of live animals by air
CARGO SERVICES CONFERENCE

(CSC)
Cargo
Dangerous Live Animals and Cargo Border
Airmail Board ULD Board Operations and
Goods Board Perishables Management
(AMB) (ULDB) Technology
(DGB) Board (LAPB) Board (CBMB)
Board (COTB)
15
CARGO SERVICES CONFERENCE (CSC)
CSCRM
Dangerous Live Animals and Cargo Border Cargo Operations

Airmail Board ULD Board
Goods Board Perishables Management and Technology
(AMB) (ULDB)
(DGB) Board (LAPB) Board (CBMB) Board (COTB)
TCR ULDR CIMP & CXML

DGR AHM
PCR LAR
16
IATA a standard setting organization
IATA adopted a supply chain approach by liaising with all stakeholders…
IATA
Cargo Services Conference (CSC)
Live Animal & Perishable Board

(LAPB)
Time & Temperature Working Group

(TTWG)
Temperature
Freight Ground controlled
Shippers Airlines Airports
Forwarders Handlers packaging
suppliers
17
IATA a Standard Setting Organization
…from the health care industry to establish common standards
2007 2010 2012 2014

Perishable Cargo PCR Mandatory Provides requirements +
Regulations (PCR) New Chapter 17 T&T Sensitive standards for
Industry standard New T&T Label transporting pharma
Sensitive Label products
Must be affixed to all

shipments booked as
T+T sensitive cargo
2008 2009 2011 2013

Mandatory
Standard
Checklist
18
Ensure that Live Animals Regulations (LAR) are updated
Promote animal care and welfare by keeping the

Live Animals Regulations (LAR) updated.
19
The Perishable Cargo Regulations (PCR) is the leader in temperature control and cold chain
management for goods from the food sectors
2007 The PCR includes:

Perishable Cargo
Regulations (PCR) ▪ Up-to-date airline and government requirements pertaining to the
Industry standard transport of perishable cargo
▪ Requirements on handling, marking & labeling
▪ Necessary packaging requirements
▪ Information on the necessary documentation required when transporting

perishable cargo
▪ A comprehensive classification of 100’s of perishable commodities

▪ Whether you are a shipper, a freight forwarder, an airline, or shipper, the
PCR is your essential guide for the for optimizing your time sensitive
supply chain.
20
IATA’s Live Animal Regulations (LAR) are already considered the minimum worldwide
standards…
IATA Live Animal Regulations (LAR)
• Live Animal Standards in the LAR are not set in isolation. The
standards are a combination of operational experience and based on
modern science
• Based on input from
• Airline members;
• Industry stakeholders involved with the transport of animals;
• Trade;
• International and national organization;
• Animal care team;
• Advisory panel.
• Provides General Container Requirements such as:

• Construction Requirements
• Ventilation Requirements
• Safety Requirements
• Animal Welfare and Health Requirements
• Food and Water Requirements
• Care and Handling Requirements
21
…for transporting animals by air
IATA Live Animals Regulations (LAR)

• IATA’s LAR is the worldwide standard for transporting live animals by
commercial airlines.
• All persons who ship, accept, handle or load animals must be familiar with
the specific handling requirements for the individual species to ensure that
animals always travel in safe, healthy and humane conditions.
• IATA LAR have been adopted by a number of countries as their national

regulations for transporting live animals
22
Regulatory authorities make reference to the IATA LAR
International Organization or Governmental Agencies
• The OIE and CITES or USFWS all reference the IATA LAR as the guidelines
that must be followed for the carriage of live animals by air;
• The Canadian Food Inspection Agency (CFIA) requires that all live animals,
including live avian and live aquatic species, transported by air be
transported in containers as specified in the latest edition of the container
requirements of the IATA Live Animals Regulations;
• The European Union has adopted the IATA LAR as the minimum standard
for transporting animals by air that member states need to comply with.
23
IATA uses different means to disseminate standards in the industry
PUBLICATIONS
STRATEGIC
PARTNERSHIPS TRAINING
PROGRAM
BUSINESS
EVENTS
INTELLIGENCE
CONSULTING
24
Overview of Export Market in Colombia
In 2018, Colombia exported total value of USD 66.6 billion worth of goods worldwide
Top ten produces in Colombia in 2018

(in millions USD)
Millions • In 2018, Colombia exported total value
0 2000 4000 6000 of USD 66.6 billion worth of goods
worldwide
Crude oil
Coal • Crude oil (6.47% of total export market

Coffee share), coal (5.37%) and coffee
(2.56%) are the top three most traded
Bananas
goods from Colombia
Non crude oil
Ferroalloys • Fresh produces such as bananas and

cut flowers and buds contribute to
Cut flowers & buds
2.03% and 1.28% of total export
Passenger vehicles market share respectively
Waste & scrap of precious metals
• Over the past five years, export of
Cane sugar
bananas increased around 58.7%
Source: CIA Factbook
25
Overview of Import Market in Colombia
15% of Colombian imported goods were transported by air
Major destinations of imports by air in Colombia in 2016
67% Marine
3.1%
5.3%
18% Land 7.6%
10.4%
15% Air 7.8%

65.9%
Bogota Antioquia Atlantico

C/marca V. del Cauca Other
• In 2016, the value of total imports to Colombia was around CIF 44.0Bn – around 55% entered Bogota
• Eldorado airport is the main airport of the country
• Pharmaceutical, technological and machinery products are the three main product groups imported by air
Source: District Department of Planning
26
Overview of Air Cargo Market in Colombia
Colombia is the country with largest share of air trade in South America
Air trade volume in South America in 2017

(% share by country)
3.4% • In 2017, total air trade volume in South
1.4%
America was 927,000 tonnes
• In 2017, Colombia has the largest size

6.5%
Colombia
of air trade market in South America,
25.8%
7.8%
Chile
with a market share of around 25.8%
Brazil
Peru
• Most of Colombian air trade consist of
11.7% goods with destination to North
Ecuador
Argentina
America
Venezuela
24.6% Other
18.8%
Source: Boeing
27
Overview of Pharmaceutical Market in Colombia
The size of Colombian pharmaceutical market was $3.419M in 2017
Pharmaceutical market share in Colombia by company in 2017

(% share)
• The size of Colombian pharmaceutical
market was $3.419M in 2017,
GSK, 12% representing 15% of total healthcare
expenditure of the country or 1.1% of
total GDP
Pfizer, 8%
• Per capita pharmaceutical expenditure
in 2016 was $64
Bayer, 8%
Other, 51%
• Colombian pharmaceutical market is
Tecnoquimicas,
7%
primarily dominated by international
players such as GSK, Pfizer and Bayer.
Sanofi, 7%
However, domestic pharmaceutical
companies started to gain market
Abbott, 7% share gradually.
Source: Procomer
28
More than 47% of Colombian imported pharmaceutical products originated from European Union
Import of medical products by origin continent in 2017

(% share)
• Most of Colombian imported
Other, 2%
pharmaceutical products come from
Rest of Europe, European Union (47%), followed by
7%
North America (27%) and Asia (8%)
North America,
South America,
27%
8% • On a country level, United States (18%),
Asia, 8% Germany (17%) and Mexico (7%) are the
largest country providers of medical
products to Colombia in 2017
European Union,
47%
Source: Procomer
29
In 2017, Colombia exported around USD 319M pharmaceutical products
Export of medical products by country of destination in 2017 Exports of pharmaceutical products in Colombia
(% share) ($Million of USD, 2013 – 2017)
700
Millions
Other, 15%
600
Costa Rica, Ecuador, 29%
3% 491
500 458 464
El Salvador,
3%
394
Dominican 400
Republic, 4% 319
Guatemala, 300
5%
200
Mexico, 5%
Panama, 12%
100
United States,
6%
Chile, 6% 0
Peru, 12% 2013 2014 2015 2016 2017
Source: Procomer
30
Around 19% of Colombian pharmaceutical products were exported by air
Export to Colombia by mode of transportation in 2017

(% share)
Other
El Dorado airports,
Marine Air transport, Airport,
transport, 81% 19% 12%
Bogota,
88%
Source: Pharmaceutical Commerce
31
Overview of Live Animals Market in Colombia
In 2018, Colombia export of live animals were close to USD50M
Top five livestock produced in Colombia in 2017 Colombia animal export by country in 2017
(in thousands) ($ Million of USD)
Millions
0 5 10 15 20 25 United States
Lebanon
Cattle 22.5
Jordan
Russia
Pigs 5.2
Iraq
France
Horses 1.2
Hong Kong, China
Ecuador
Sheep 1.0
Spain
Vietnam
Goats 0.8
0 20 40 60 80
Source: FAOSTAT
Millions
32
Overview of Fresh Product Market in Colombia
Major types of commodities by air from Latin America to North America
Commodities transported by air from Latin America to North

America
• The top three product category
transported by air from Latin America to
North America are all perishable
23.1%
products:
Flowers
27.2%
Fish • Flowers (27.2%)
Fruits and vegetables • Fish (25.6%）

6.7%
Small packages and
shipments
• Fruits and vegetables (17.4%)
Other
17.4% 25.6%
Source: Boeing, flexport
33
Fresh produce exports in Colombia is led by bananas, plantains and pineapples
Top ten produces in Colombia in 2017

(in tons)
• Colombia is the third largest country in
Millions
- 10 20 30 40
Latin America in terms of area of
planted lands for fruits and vegetables
Sugar cane
Oil palm fruit • Fresh produce exports in Colombia is

led by bananas, plantains and
Bananas
pineapples
Plantains and others
Rice, paddy • Fresh fruits with the most growth

potential are avocados (increased by
Potatoes
182% in 2016) and pineapples (241%)
Cassava leaves
Cassava
Maize
Pineapples
Source: FAOSTATS, Oxford Business
34
United States is the largest importer of vegetables produced in Colombia
Colombia export of vegetables by region in 2017 Colombia export of vegetables by country in 2017
($ Million of USD) ($ Million of USD)
Millions Millions
0 2000 4000 0 1000 2000 3000
North America 2,727.5 United States 2,490
Europe &Central Asia 2,090.7 Belgium 412
East Asia& Pacific 498.6 Netherlands 406
Latin America & Caribbean 338.4 Japan 311
Middle East & North Africa 47.8 United Kingdom 276
Sub-Saharan Africa 2.0 Germany 274
South Asia 0.5 Canada 238
Source: World Integrated Trade Solution
35
Case: Colombia Cut Flower Export
Colombia is the world’s second largest cut flower export country
World’s largest cut flower export countries in 2018

(% share)
1%
2% • Colombia is the world’s second largest cut
1% 1% 11% Netherlands flower export country with around 16% market
Colombia share
1%
Kenya
2% Ecuador • In 2018, total export of flowers exported from
Ethiopia Colombia was USD 1.4Bn
9% 48% Malaysia
China • United States is world’s largest importer of fresh
Italy cut flowers – in 2018, total imported value
8%
Belgium reached around USD 8.9Bn
Germany
16% Rest of the world • Around 60% of United States’ imported flowers
were from Colombia
Source: ITC
36
Top 5 importers of Colombian fresh cut flowers
2.7% • Colombian flowers were distributed

to 89 countries
2.4%
78.4% 2.8%
• 80% of Colombia’s flower exports
3.7%
go through the El Dorado
International Airport in Bogota
Top 5 importers of
Colombian fresh cut
flowers
1. United States (78.4%)
2. Japan (3.7%)
3. United Kingdom (2.8%)
4. Canada (2.7%)
5. Netherlands (2.4%)
Source: ITC
37
Flow chart for Colombian flowers to United States
Farm Farm truck to Post-harvest Refrigerated El Dorado Airport

post-harvest collection point truck (1 hour) (4 – 8 hours)
collection point
Retailer Refrigerated Miami Airport Airfreight

truck (6 hours) (2 – 4 hours) (6 hours)
Source: Worldbank
38
How to become CEIV
Pharma Certified
Content Page
3.1 Introduction: Pharma logistical market growing

3.2 However, air cargo losing market share to other modes of transportation
3.3 Objective: CEIV Pharma is a concerted effort to improve the level of competency,
3.4 Approach and methodology: Validate knowledge, facilities, as well as processes, train
stakeholders and recognize compliance
3.5 Benefits: A win-win opportunity for all stakeholders
3.6 CEIV Pharma: Update of activities
40
Background: Pharmaceutical Market Development
The global biopharma sales trend is projected to go upwards
Global Biopharma Sales Trend 2014 - 2022

($ Billions)
• By 2022, world sales of cold-chain drugs and
$1,600
$1,430 of biologics will likely top $416 billion, in a
$1,400 $1,310 global biopharma market exceeding $1.43
$1,188 trillion.
$1,200 $1,105
• An expansive future for cold chain logistics
$1,000 is expected (at a 5–6 % growth rate), driven
$1,014
$940 by
$800 $870
$833 • continuing transition to biologically based
$600 products;
$416
$400 $318
$370 • tightening requirements for life sciences
$272
shipments;
$200 • growing internationalization of
$0 pharmaceutical trade;
2016 2018 2020 2022 • continued strong growth in vaccines; and
Cold Chain (+53% growth) Non-Cold Chain (+26% growth) Total (+29% growth) • continued expansion of clinical trials
logistics
• broader adoption in underdeveloped
economies.
41
Cold chain logistics spending is expected to be fastest in Asia and in North America
Global Biopharma Sales Trend 2014 – 2022 / Per region

($ Billions)
• With 20% of world’s population, Europe and
North America consume more than 60% of
$20 $18.6 the total pharmaceutical products (in dollar
$18 $16.8 $1.4 terms).
$16 $15.0 $1.2
$14 $13.3 $1.1 $4.7 • If Asia and the rest of the world used
$4.2
$0.9 pharmaceuticals at the same level as Europe
$12 $3.7
$3.3 and North America, the global market would
$10
$6.6 be 3x as large.
$8 $6.2
$5.8
$6 $5.3 • Asia is expected to account for the largest
$4 regional share growth with ~$1.5 billion in
$2 $4.4 $5.2 $5.9 cold-chain logistics spending growth between
$3.8
2018 and 2022.
$0
2016 2018 2020 2022
Asia Europe North America Rest of World
42
Spending in biopharma logistics will continue to rise to meet demand
Global Biopharma Logistics Spending (2016 – 2022)

($ Billions)
• It is estimated cold-chain logistics
$93.7 spending in 2018 will be about $15.0
$86.7
$100 $82.3 billion worldwide in a $82.3 billion overall
$73.3 pharma logistics market.
$90
$80 $18.6
$16.9
$13.3 $15.0
$70
$60
• The year-over-year growth rate is ~8% for
cold chain logistics and ~2%for non-cold
$50
chain logistics.
$40
$69.8 $73.1
$66.0 $67.3
$30
$20
$10
$0
2016 2018 2020 2022
Non-Cold Chain Cold Chain
43
It is estimated the global industry will spend $15 billion on cold chain logistics in 2018, up from
$10.1 billion in 2015
Estimated Breakdown of Logistics Spending (2015 vs 2018)
($ Billions)
• It is estimated $10.6 billion will be
spent in cold chain transportation
$4.8 $7.0 $4.7

$10.6
• $4.4 billion will be in specialized
tertiary packaging and instrumentation
$3.1 $4.4 such as:
$4.8 $7.0 $3.1 • insulated boxes;
• blankets;
• phase-change materials;
• active temperature-control shipping
$43.1 $62.6 containers; and
$43.1 • various temperature sensors and
recorders.
Cold Chain Transport Cold Chain Packaging • There is a trend towards more
Non-Cold Chain Transport Non-Cold Chain Packaging spending on devices and systems for
controlled room temp (CRT)
44
Out of the USD 10.6B, USD 7.8B of Cold Chain Transport Spending will be spent on Air Freight
Estimated Breakdown of Cold Chain Transport Spending By Mode (2018)

($ Billions)
$0.1
$4.7
$2.7
$10.6
$62.6
$7.8
$4.4
Air & Parcel Sea Truck & Multi Mode

45
Background: Pharmaceuticals Use Air Transport
Pharmaceutical transport by air has shown stronger growth than the air cargo market as a whole
Long Term Air Trade Growth 2000 - 2016 (% CAGR)
5.0% 4.7%
4.5%
4.0%
3.5% 3.4% 3.4%
3.0% 2.7% 2.8%

2.6%
2.5% 2.4%
2.0% 1.8%
1.5%
1.5%
1.0%
0.5%
0.0%
Raw Materials High Tech Machinery Perishables Fashion Chemicals Automotive Pharma Global Air Trade
Source: Seabury Global Trade Database (May 2017)
46
The United States is the biggest exporter and importer of pharmaceuticals by air
Pharma Air Trade Destinations JAN-AUG 2017 (Thousand Tonnes)
0 50 100 150 200 250 0 50 100 150 200 250
USA 86 USA 73
India 54 China 23
Germany 33 Japan 13
Export Import
China 20 Germany 13
France 19 Brazil 12
UK 14 Netherlands 9
Belgium 12 India 8
Other 127 Other 214
Source: Seabury Global Trade Database (November 2017)
47
Pharmaceutical represent an important and lucrative sector for air cargo, contributing
approximately US$ 1.4 billion to total airline cargo revenue
Pharmaceutical Trade By Air 2017 Per Volume, Airline Cargo Revenue and Value (%)
10.0%
9.0%
8.0%
7.0%
6.0%
5.0%
9.4%
4.0%
3.0%
2.0%
1.0% 2.6%
1.9%
0.0%
Volume Airline Cargo Revenue Value
Source: Seabury Global Trade Database (November 2017)
48
Pharmaceuticals shipped under CRT, COL or ACT command an average premium of 25-60%
above the rate charged for the average air cargo shipment on the same country pair
Pharma Rates by Handling Code 2017
2.5
1.5
CRT = Controlled Room

Temperature
1
Avg. Air Cargo Rate = 1 COL = Cool Goods
0.5 ACT = Active Temperature

Controlled
0
Avg. Air Avg. PIL Avg. CRT Avg. COL Avg. ACT
Cargo
Source: IATA Economics
49
As a result, pharma air trade growth is based on high value pharma products (> $150/kg)
compared to pharma ocean trade growth which relies on low value products (< $15/kg)
Pharma Trade By Product Value: Air vs Ocean 2000 – 2016 (Thousand Tonnes)
600 6000
188 550 255 73 5,437
AIR OCEAN 586
500 5000
1,792
400 82 4000
300 265 23 3000 2,731
-8
200 2000
100 1000
0 0
Source: Seabury Global Trade Database
50
Content Page

51
Background: Air freight has lost “market share” to ocean freight
Over the past 16 years, ocean pharma trade has added significant volumes particularly in the
mid-value pharma category
Pharma Share: Air vs Ocean

Global Trade of Pharma, 2016 Air Weight Share, 2000 – 2017 (MAR)
30%
Air Share Losing Out to

OCEAN 91% Ocean
70%
AIR 9%
Weight Value
Source: Seabury Global Trade Database
52
Background: Critical Issues Raised by the Shippers
The use of air-mode transportation is re-considered unless industry partners ensure quality
services
Of vaccines reach their destination

25% degraded because of incorrect
shipping
Of scrapped pharmaceuticals can
30% be attributed to logistics issues
alone
Of temperature-sensitive products
20% are damaged during transport due
to a broken cold chain
• Due to a lack of compliance, standardization, accountability and transparency across the air transport
supply chain a majority of all temperature excursions occur while the package is in the hands of
airlines/airports.
• Temperature deviation denature the product, render it worthless and be harmful to the health of the patient.
• Products can be lost, scrapped, returned leading to significant costs.
53
Background: Critical Issues Raised by the Shippers
Looses associated with temperature excursions in healthcare are around a staggering ~USD 35B
Losses associated with temperature excursions

In USD Billion
Total: USD 34.1B

1.00
3.65
2.35
• The average costs of root
15.20 5.65 cause analysis for each
2 excursion can range from $3K
to up to $10K (avg. USD
1.3 6.5K per year)
8.60
Opportunity Labor Costs Direct Labor Costs
Trial Production Costs
Wasted Logistic Costs Replacement Costs Clinical Trial Costs
Root Cause Analysis Lost Product Cost
Source: World Health Organization, Parenteral Drug Association, worldpharmaceuticals.net, cargosense.com, other industrial analysis
54
Air Cargo Industry Concerns and Challenges
Temperature Excursions – Where do they occur?
Origin
Freight Airline
Manufacturer Trucker Airline
Forwarder Cargo Handler
Transfer
Airline
Airline Airline
Cargo Handler
Destination
Airline Regulatory Freight

Airline Trucker Trucker Consignee
Cargo Handler Authority Forwarder
Source: Expeditors Low Risk Medium Risk High Risk
55
Air Cargo Supply Chain Challenges
The process is quite complex and shippers have difficulties to identify stakeholders that meet
standards and regulations
Example of Flow from BRU to SYD

Shipper Forwarder X Forwarder Y Consignee
BRU SYD
Pick-up In Out In Out In
In Out BRU out SIN in out SYD in In Out
Ground handler BRU Airline BRU – SIN - SYD Ground handler SYD
14 milestones from start to end.

HOW CAN YOU MANAGE THIS ?
56
Temperature control share of pharma
Temperature management market, 2013-2017

In percentage of total business
• A big share of pharmaceutical shipments in the 15-
25°C segment are shipped as general cargo.
Active Passive
Temp 10% 10%
20%
Control
25% • A significant part of pharmaceutical shipments
30%
45%
requires temperature controlled transport.
• 75% of shipments require passive cooling

90% 90%
General
80% solutions, and
Cargo 75%
70% • 20% require active temperature control.
55%
• Active temperature control solutions demand a
yield premium due to complex requirements.
• Passive solutions drive volume and are less
Pharmaceuticals A B C D E
costly to implement.
Source: Seabury, BRU Cargo
57
From origin to destination pharmaceutical products can be exposed to different climates
IN-FLIGHT
Manufacturer & CONDITIONS
Shippers
LOADING
PACKAGING Distributors
& Consignees
Solutions UNLOADING
Providers
Airport AIRSIDE Airport

Origin Forwarders Ground Handlers TRANSPORT Ground Handlers
& Trucking Co’s
Destination Forwarders
& Trucking Co’s
HANDLING HANDLING
HANDLING ROAD ROAD
TRANSPORT TRANSPORT
-10°C +35°C
58
Air Cargo Industry Concerns and Challenges
Heavily regulated industry with no global standards and certification for handling of
pharmaceutical products
Regulations for transporting pharmaceutical

products vary around the world
• Increasing number of regulations around the
world to implement and comply with
• Increasing number of audits
• Airlines, GHAs and forwarders subjected to

multiple audits for handling, transportation
and distribution (e.g. WHO Appendix 5, EU
92/25/EEC, IATA PCR Chapter 17 & TCR)
• No global certification for handling of

pharmaceutical products
59
Shippers Expectations in Cold Chain
Modal shift is a reality because shippers need products to maintain integrity and efficacy during
transportation
• Compliance, standardization, accountability and transparency across

the supply chain
• Properly trained stakeholders on regulations and standards
• Adequately equipped facilities throughout the supply chain
• Global certification for handling of pharmaceutical cargo
• Common audit format to minimize the disruptions and increase

effectiveness
• Ability to easily search and identify stakeholders that meet

requirements
60
More compliance on the horizon?
Growing regulatory environment, higher business complexity and increased focus on
accountability
• Pharmaceutical companies operate in one of the most dynamic environments.
• Changes in regulations by leading bodies such as US Food and Drug Administration (USFDA) and the
European Medicines Agency (EMA) have increased the significance of regulatory compliance
management for drug manufacturers.
• Pharma companies across the globe are compelled to alter their compliance practices to conform to
changes in regulations and stringent anti-corruption laws.
• Historically pharmaceutical industry has been dealing with malpractices across the value chain ranging from
improper branding to masking safety information and disregarding quality manufacturing standards. This has led
to regulators keeping a strict watch on the pharma companies.
• Enforcement agencies the world over have become more active. Any violation of regulatory methods or non-
compliance of standards could tarnish a company’s reputation, risking its future.
• According to the 2014 global survey on reputation risk conducted by Deloitte, reputation problems had a severe
impact on revenue, loss of brand value and regulatory investigations.
61
More compliance on the horizon?
In the US and European markets, companies have become increasingly cautious about
regulatory compliance
Pharma shippers situation Impact on Air Cargo industry
• Leading pharma companies in these markets have • Compliance is a priority for the air cargo sector.
reportedly implemented effective compliance • Air cargo sector performance not encouraging and
management systems internally. increased regulation will continue to contribute to the
compliance challenges facing the industry.
• Pharma companies are realigning their quality and • They will demand the same from their business
compliance structure to conform to the constantly partners.
evolving regulatory guidelines.
• With the FDA and other regulators broadening the scope of • Companies ought to be proactive in setting up stringent
compliance requirements, it helps if companies have a internal controls as part of their commitment towards quality
holistic approach and make regulatory compliance part and compliance.
of their corporate strategy. • Include effective training, proper timely communication,
periodic reviews / follow-up, and support from the top
management.
Challenge Will Regulators focus on aligning country-specific regulatory

frameworks to global standards enabling harmonization of
standards and help companies drive efficiencies?
62
Content

3.3 Objective: CEIV Pharma is a concerted effort to improve the level of
competency, operational and technical preparedness
63
Center of Excellence for Independent Validators
for Pharmaceutical Logistics (CEIV Pharma)
Inspired by Shippers, Driven by Industry!

64
Center of Excellence for Independent Validators (CEIV)
Improve together to protect and grow our industry
The solution
The Need
▪ … for more safety, security and  Develop standards with regulators
efficiency
 Train industry stakeholders on standards and
▪ … to raise the bar to (re)gain confidence regulation
▪ … to improve compliance to  Assess operations against standard check list

standards/regulations
▪ … for independent assessments vs.  Train independent validators on standards

self-assessments and regulations
▪ … to identify and recognize the best  Certify and then register best players on a
players publicly website
▪ … to harmonize and reduce the number  Get States recognition to ensure audits are
of audits valid for all
65
Approach of the CEIV programs
EXISTING NEW
1 2 3 4 5
Standards and Training Validation Re-
Regulations
Regulations and Standards (Recurrent Assessment (Audit) & Validation
Training) Award (Re-Audit)*
▪ Advocate for globally accepted standards and regulations

▪ Train instructors on behalf of the airlines, cargo and ground handlers
▪ Manage the pool of qualified instructors
▪ Train the Independent Validators to a common standard and validation methodology
▪ Train operational staff
▪ Run on-site pre-audits to prepare for validation
▪ Conduct the validations
▪ Manage the database of Independent validators
▪ Manage the database of certified companies
66
Center of Excellence for Independent Validators (CEIV) for Pharma
The CEIV Pharma aims to ensure a higher and more consistent level of pharmaceutical handling
through validations with registered independent validators and instructors
EXISTING NEW
1 2 3 4 5
Standards and Training Validation Re-
Regulations
Regulations and Standards (Recurrent Assessment (Audit) & Validation
Training) Award (Re-Audit)*
▪ Advocate for globally ▪ Develop training ▪ Develop pre- ▪ Manage deployment ▪ Manage database of
accepted standards contents validation of validators validated locations
and regulations ▪ Develop assessment assessment toolkit ▪ Audit documentation, and operators
▪ Establish validation criteria for instructors ▪ Develop a standard processes and ▪ Manage re-validation
checklist with and validators exam validation operations schedule
industry ▪ Train instructors, methodology and consistently
▪ Establish industry validators and assessment tool ▪ Manage quality of
steering group industry stakeholders validations
▪ Manage database of ▪ Follow-up
certified instructors ▪ Award and recognize
and validators operators and
locations as "CEIV
Pharma certified"
67
CEIV Pharma
To ensure the integrity of the product throughout the supply chain
OBJECTIVES
Prevent sanitary issues caused by temperature Improve handling of pharmaceutical products and
excursions during transportation. compliance with existing regulations +
standards.
Ensure product integrity
Elevate staff competency levels through efficient and Create a global and consistent certification that
robust training program. industry can rely on.
68
CEIV Pharma Targets
Who does CEIV Pharma target? The supply chain
From point of origin to destination
3 4
Origin
Shippers Ramp/Cargo Airports Consignee
Handlers
1 2 5 6 Destination
Trucking Freight Airlines Ramp/Cargo
Companies Forwarders Handlers
69
CEIV Pharma Standard
CEIV Pharma standard focuses on global coverage and universality
IATA GUIDELINES GOOD LOCAL +

DISTRIBUTION REGIONAL
PRACTICES GUIDELINES
E.g. Singapore
+ + GDP & GDPMDS

or FAGG in
Belgium
CEIV Pharma:
= =
• encompasses various regulations and standards e.g. EU GDP.
• covers GDP requirements.
• aims at covering international standards and country-specific requirements.
• aims at reducing the number of audits or simplifying them.
• aims to align air cargo stakeholders needs.
70
Review, compare against best practice, offer recommendations for change, identify and mitigate
risks, develop implementation plan
Criteria applied Issues tackled

• Quality management • Content of manuals and guidelines
• Personnel • Procedures for Audits
• Training • Procedures for describing packaging
systems
• Documentation
• Acceptance checklist quality and operating
• Infrastructure + equipment
agreements
• Operations
• Packaging requirements
• Complaints, returns and counterfeit
• Documentation & labeling
• Supplier management
• Acceptance & control
• Self-inspections
• Facilities and equipment
• Transportation
• Staff training requirements
• Specific provisions for brokers
• Training adequacy and currency
71
Compliance vs. non-compliance
IMPORTANT
Non-Conformance Ratings:
MINOR non-conformance – minor or less serious non-conformance which is

unlikely to pose a risk to product quality;
-> need to be closed for the CEIV Certification
MAJOR non-conformance – failure to satisfy a key or mandatory requirement

and/or one which may pose a risk to product quality;
-> need to be acted upon for the CEIV Certification.
Recommendations are provided as suggestions for potential

improvements only and won’t be reviewed for CEIV Certification
72
EU GDP – CEIV Pharma Comparison
CEIV Pharma aims at global and consistent assessments specific to air transport
GDP’s are:
▪ in some cases very region centric
▪ not consistent and not transparent GDP
Local
▪ not supported by shippers for air cargo industry regulations
▪ focused on storage of pharma, not transportation
▪ not aligning stakeholders in the supply chain
TCR
▪ ignoring transport in areas such as such as
ground/tarmac transportation and aircraft (un)loading
which are not covered by existing GDPs.
▪ CEIV Pharma focus is placed on unique handling

and storage circumstances that apply to air cargo
transport
73
CEIV Pharma aims to avoid one of the most “dangerous misunderstandings” of GDP certification
1 4 Gap filled by non- 5

Transport companies
accredited bodies who
face strong pressure to
be listed in the
issue commercial GDP “QP” Certificates from
certificates which are not independent consultants
EudraGMDP Database
compliant as they are are also not valid
of companies meeting
not issued by competent
EU GDP compliance
supervisory authority
2 3 However GDP
As per EU GDP SOLUTION?
Competent Authorities do
Guidelines, only
not typically carry out
competent supervisory
GDP inspections at
authorities can carry
transport companies
out GDP inspections
(shipping companies)
or at airport hubs
Source: GDP Group, 14/10/2015
74
GDPs assist wholesale distributors in procuring, holding, supplying or exporting medicinal
products, CEIV Pharma focuses on airfreight and temporary storage
EU GDP IATA CEIV Pharma
Wholesale Distribution Authorization CEIV Certification
Wholesalers, 3PL’s with storage activities Supply Chain Stakeholders
Procuring, holding, supplying or exporting medicinal Handling and transporting pharmaceutical products
products by air
EU Guidelines International Regulatory requirements, Regulations
and air freight standards
Encompasses storage and distribution requirements Focuses on air freight and temporary storage
Applied interpreted by each Member States (e.g. Globally harmonized with consistent requirements
warehousing rules)
Accredited service providers will carry out GDP Validation also on air freight operations (e.g.
inspections at transport companies or at airport hubs ground/tarmac transportation and aircraft
(un)loading)
Country specific auditing tools Same Audit Checklist everywhere
Considered as a reference globally Recognition is increasing in the industry
75
Which compliance recognition program to choose from?
…The one that best meets your needs and

requirements!
• Does your company comply with the required regulations?
• Does your company need a level of recognition?
• Does your company need a WDA (Wholesale Distribution
Authorization)?
• Where in the supply chain is your company?
• Are the activities out of Europe, international, global?
• ......?
Keeping in mind that the industry
is following the same objective…
76
A collaborative approach is vital
…Patient safety…
It is collaborative responsibility!
77
Content

3.4 Approach and methodology: Validate knowledge, facilities, as well as
processes, train stakeholders and recognize compliance
78
Certification Approach and Methodology
IATA will certify companies in several steps
1 3 4
Preparation Assessment Validation
• Assemble team • On-site assessment by • On-site visit by an 5

• Prepare project logistics Independent validator Independent Validator to
Certification
• Assessment versus ensure full compliance with
• Send data and information minimum IATA CEIV the IATA CEIV Pharma
request Pharma Checklist checklist and also review
• Send interview request • Comparison against best the progress made against
sheet for first visit practice recommendations during
• Establish findings and offer the assessment phase
recommendations for • Drafting of report
change
• Develop implementation
plan and secure resources
• Draft gap analysis report
2 6
Additional
Training required for certification Training
79
Training required for certification
Successful completion of the courses is essential for certification
Training required for

certification
Temperature Audit, Quality and

Controlled Risk Management for
Cargo Operations Temperature
Controlled Cargo
Successful completion of:

• 2 key personal on the “audit” training (5 days); and
• 2 competent personal on the “handling” training (3 days).
80
Training
Temperature Controlled Cargo Operations

certification
Key topics:
• The regulatory environment
• Overview of the global pharmaceutical industry
• The differences between “ordinary” perishables and healthcare products
• Packaging Technology
• Documentation and Labelling
• Handling Procedures and Acceptance Control
• Temperature Management in the supply chain
• The critical control points and associated risk factors
• Service Level Agreements (SLAs) and Standard Operational Procedures (SOPs)
• Quality Management
✓ 2 competent personnel per station should be trained on the Classroom course
81
Training
Audit, Quality + Risk Mgt. for Temperature Controlled Cargo

certification
Key topics:
• The Regulatory framework
• Quality Management System (QMS)
• Audit and Quality Control Principles
• Self assessment and validation
• IATA Time and Temperature Sensitive Audit Checklist
• Effectiveness of risk management control
• Trigger corrective and preventive measures
• Quality Risk Management (QRM)
• Risk assessment, control and management methodology
• Root Cause Analysis and Lean Basics
✓ 2 key personnel per station should be trained on the Classroom course
82
For both, key personnel vs competent personnel, successful completion of the course is a pre-
requisite for certification

certification
Temperature Controlled Audit, Quality and Risk Management

Cargo Operations (3 day for Temperature Controlled Cargo (5
classroom) days classroom)
2 Competent personnel per station 2 Key personnel per station

• Handling manager • QA manager
• Warehouse manager • Pharma product manager
Who? • Shift manager for acceptance, • Station manager
handling, ramp and storage of • Internal Trainer
pharmaceutical goods • …
• Other staff involve in procession
pharmaceutical goods
83
Training Options In-Company vs Training Center

certification
TRAINING IN-COMPANY
CENTER TRAINING
$ $$ Cost
4 12 No. of Participants
Inflexible Flexible Location
84
Assessment
Focus is on preparing the organization for validation and creating awareness
Assessment
Raise awareness On Pharma handling requirements
Assess client To identify potential gaps using the IATA CEIV Pharma checklists
Of facilities, staff, equipment, processes, practices, and

Conduct on-site observation
systems
Prepare client For the subsequent validation exercise
Capture and convey ‘lessons

To assist client in achieving "CEIV Pharma Certified" status
learned’ and suggest ‘best practice
Analyze observations
Highlight findings and provide recommendations
and produce report
Collaborative work Helping creating an action plan and project plan
85
Validation
Validate to ensure all requirements are in compliance, …
Validation
Review of progress on action plan
Action
• During the validation, the independent validator will Packages
• Schedule
go through the checklist one more time and also
review the progress made against recommendations
during the assessment phase Actions
• Personnel
• Quantitative
• Qualitative
Implementations
• At the end of validation decision on

whether all requirements have been
fulfilled.
86
Validation
…and gaps as well as recommendations have been implemented
Validation
▪ After 2 months IATA

reserves the right to
request ▪ If the client does not
▪ Client agrees to close ▪ an up-to-date action supply IATA satisfactory
minor findings identified plan, together with information within thirty
during the validation (30) days of IATA
process and recorded as notifying the client, then
▪ the last Self-Inspection
open in the final validation IATA will withdraw its
report and associated
report within a timeframe CEIV Pharma
action plan, as well as
of two (2) months. registration certificate
with immediate effect.
▪ the Minutes of the last
Management Review.
87
Assessment and Validation
Deliverables
Step 1: Assessment Step 2: Validation
• Pharma handling criteria checklist. • Progress report to review the progress made
• Report covering the findings and against recommendations during the assessment
recommendations based on the assessment. phase.
• Implementation plan. • Implementation plan update.
• Report and implementation plan will set out • Recommendation to award certification as "CEIV
assumptions, findings, results, conclusions and Pharma certified" based on satisfactory compliance
recommendations and will specifically: of CEIV criteria.
• Identify critical elements that are not compliant • Presentation of the validation findings to Senior
with national and international Regulations and the Management.
defined CEIV Pharma Handling criteria (e.g. TCR);
• Outline the impact of non-compliance; and
• Identify elements that are inefficient.
• Presentation to Senior Management.
88
Additional Training
Introduction to Time and Temperature Pharmaceutical Products
Additional Training
4-6 hours training. Key topics:

• Pharmaceutical products
• Processes & procedures related to job functions
• Identification and labelling
• Effect of temperature on pharmaceutical products
• Avoidance of counterfeits
• Passive and active packing
• Product security
All personnel involved in handling pharmaceutical products activities per station
should be trained on “IATA Introduction to Time and Temperature Pharmaceutical
Products course“ (or equivalent)) within period of 12 months after the “Certification”
89
CEIV Pharma: Path to Certification
In a nutshell
Step 1 Preparation
Step 2 Training
Step 3 Assessment
Step 4 Validation
Step 5. CERTIFICATION
Step 6 Training (remaining staff)
90
Certification Timeline (general approach)
Over the years we have seen companies completing the process within 6-7 months
4-6 12-26
weeks weeks
2 days on- 2 days on-
site Timeframe site
depends on
results of
assessment.
Additional
4-12 weeks
12 months
• Ideally completed before
after
assessment.
certification
• Needs to be completed before
validation.
91
Certification Timeline (requirement)
Pharma shippers demanded to impose timelines
Not more than 6 months Not more than 12

Mandatory Trainings between latest training Assessment months between Validation
and assessment assessment + validation
• In case companies pass deadline, key

personnel need to take refresher training
Total certification not to last longer than 18 months from last training to certification
CEIV Pharma 92
CEIV Pharma Caveat
Once a client obtains the CEIV Pharma Certificate, IATA or an IATA representative mandated by
IATA will have the right to conduct spot checks to ensure continuing quality of the certification
• Client agrees to close minor findings identified during the validation process and recorded as open in the final
validation report within a timeframe of two (2) months. After two (2) months IATA reserves the right to request an up-
to-date action plan when minor findings identified during the validation process were still recorded as open in the
final validation report, together with the last Self-Inspection report and associated action plan, as well as the Minutes
of the last Management Review. If the client does not supply IATA satisfactory information within thirty (30) days of
IATA notifying the client, then IATA will withdraw its CEIV Pharma registration certificate with immediate effect.
• In order to determine whether a client and/or station that has received the CEIV Pharma Certificate still meets the
criteria, IATA reserves the right to require at any time, submission by the client of all required current documentation
and information relating to the certification for IATA’s review and approval. If the client does not supply IATA
satisfactory information within thirty (30) days of IATA notifying the client, then IATA will withdraw its CEIV Pharma
certificate with immediate effect.
• In order to determine whether a client and/or station that has received the CEIV Pharma Certificate still meets the
satisfactory information within thirty (30) days of IATA notifying the client, then IATA will withdraw its CEIV Pharma
CEIV Pharma 93
Recertification
Recertification will take place every three years – includes assessment and one refresher training
plus a validation if necessary
CEIV Pharma
Certified Re-assessment
3 years Max. 2
✓
days
X Close
gaps
Validation
1 - 2 days
REFRESHER TRAINING
• e.g. update on new regulations, development on new
standards, development of new containers, etc.
94
Content

95
CEIV Pharma – Key Benefits
CEIV Pharma is a win-win situation for the industry
Shippers Airlines, GHAs, Forwarders, Airports

• Conduct simpler audits of operators • Protect and grow revenues in fastest growing segment of
• Obtain guarantee that products would be handled in line air cargo
with regulations • Obtain recognition for operations, facilities and staff after
• Experience lower rate of damage and loss due to meeting standards
temperature excursions • Experience simpler audits from various organizations
• Be able to prepare their products ready for acceptance • Promote their best practices to the shipper’s community
• Speak with one voice
Regulators IATA
• Ensure safety of pharmaceutical products shipped by air • Disseminate standards in the industry
• Access to structured and consistent training • Common audit criteria and global certification
• Registry of independent validators and certified • Promote air transport and so limit the modal shift
operators
96
Content

97
CEIV Pharma Development
From Pilot to Launch
Launch of
Community
Joint development of Concept at BRU
Community Concept
with BRU
SATS Pilot Official launch of CEIV Recertification of CEIV Pharma

Pharma program program
Discussion
with SATS
about a Pilot
Development of CEIV Pharma Development of CEIV Development of CEIV Pharma Standard Development of CEIV Pharma Standard
Standard 1.0 Pharma Standard 1.0 1.1 and 1.2 + Guidelines 1.3 + updated Guidelines
All companies of the first community will

undergo recertification
Unreliable cargo industry loosing
pharma industry: IATA sleeping
09/13 11/13 01/14 03/14 05/14 07/14 09/14 11/14 01/15 03/15 11/17
98
CEIV Pharma Checklist
CEIV Pharma checklist and guidelines will be included in IATA’s Temperature Control
Regulations as Annex
CEIV Pharma Audit Checklist
CEIV Pharma Audit Guidelines
99
Visibility for CEIV Pharma validated entities
Validated entities are visible on IATA’s website
100
Visibility for CEIV Pharma validated entities
New database combining different IATA certifications under one roof – Coming in 2019
Preliminary layout
101
CEIV Pharma (Certified Entities)
Certified Pharmaceutical Trade Lanes Development
1
11 2 3
21
14 1
2 5 11
11
1
2 12 5 9
29 3 2 4
1 15
8 1 1
2 1 7
1 5
2 3
2 2 2
Locations 10
1
229 Certification Completed 1
1
Certification in Progress 1
+75 (estimate) 1 1 3
1 1
+99 Certification under discussion *
* Estimate
102
CEIV Pharma (Community Approach)
Community Approach Development Worldwide
Location
20 Ongoing Communities
6 Communities in Discussion
103
Endorsement from European Shipping Council
104
Endorsement from Belgian Regulator
On November 25, 2014, the Belgian Regulator FAGG – AFMPS formally endorsed the CEIV
Pharma Program
The Belgian regulator, the federal agency for medicines and health
products (famhp) is endorsing the IATA CEIV program. It has been
involved in the BRUcargo community certification from the start of
the program. Famhp Inspectors have also participated in the
training sessions and workshops.
Josiane Van der Elst, Director General DG Inspection FAGG says
“Although this type of IATA certification is not an authority-issued
regulatory document, initiatives of structured control on transport are
important and welcomed by famhp DG INSPECTION. The IATA
certification gives more confidence that pharmaceutical air freight
shipments are handled in accordance with EU GDP guidelines”.
fagg – afmps, November 25, 2014
105
Testimonials This is not an IATA program. It was drawn up
‘IATA CEIV Pharma is an industry-wide standard that serves as a sign by the pharma shippers and ourselves and
of the commitment we are making not only to our customers but also to disseminated by IATA. The criteria are set by
pharma industry and end consumers. It has been a year since the shippers and ignoring this program is
AirBridgeCargo Airlines have gained IATA CEIV and we were able to ignoring the interests of the pharmaceutical
demonstrate our ability to protect quality, integrity and consistency of industry.”
temperature-sensitive pharma products. Being perceived as an industry Steven Polmans, Head of Cargo, Brussels
benchmark, CEIV raised the bar of our performance, encouraging our Airport
customers’ level of credibility and increasing our volumes, which
constitutes 3% of total cargo carried for 9 months of 2017 – significant
twofold increase as a confirmation of our competency and expertise in
Holistic/community approach
pharma sector.’
is the competitive advantage
Fedor Novikov, Pharma Director, Global AirBridgeCargo Airlines Holistic/community approach
vs other program. The fact
that the program is industry is the competitive advantage
specific is a key differentiator vs other program. The fact
vs GDP. that the program is industry
specific is a key differentiator
Frank van Gelder, Adelantex, vs GDP.
Freight Forwarder
‘it is obvious that we in Duesseldorf engaged for this ever Frank van Gelder, Adelantex,
increasing vertical and are glad to share this with you.. Duesseldorf Freight Forwarder
Airport is situated in one of the most industrialized regions in
Europe where Pharmaceutical Manufacturing plays a vital role!
Ever since we obtained our certification, we saw an increase of
15% of Pharmaceutical Products going through our facilities. The program helps reducing the scope of
“Increasingly, we are seeing more Gerton Hulsmann, Managing Director, Duesseldorf Cargo GmbH shipper audits. CEIV is good sales tool to
shippers requesting for their promote our business to clients: it ensures
pharmaceutical cargo to be routed via IATA a robust cold chain in every step in the
CEIV Pharma certified hubs and trade supply chain through the airport for
lanes.”. handling the pharma shipper’ temperature
sensitive products.
Mr. Lim Ching Kiat, Managing Director, Air
Hub Development at Changi Airport Group Eric Veeckmans, UTi Brussels, Freight
Forwarder
106
How to become CEIV
Fresh Certified
Content
4.1 Introduction: Perishable logistical market growing

4.2 Objective: However, air cargo faces several challenges
4.3 Objective: CEIV Fresh is a concerted effort to improve the level of competency,
4.6 CEIV Fresh: Update of activities
108
Economic growth is the main driver behind air freight
20-year forecasts for freight tonnes kilometers from 2017 to 2035

(Index 100)
• Air cargo services are connecting global
markets regardless of the geographic
locations
• The growth for air freight is expected to

double in the next 20 years, and the main
driving force is worldwide economic
development
• Back in 2014, over 80% of worldwide

perishable food is imported by developed
countries. Today with the increase of
income and population in developing
nations, the perishable trades also shift
from developed to developing countries
Source: IATA Economics

109
Demand for fresh products is growing worldwide
Consumer spending on fruit and vegetables by geographic location

(% share)
€ 2.1tn € 4.8tn • Perishable cargos is a general category of

100% air freight that refer to time-sensitive agro-
11% 8%
90% 8% food products and horticultural products
8%
80% such as seafood, meat, fruits, dairy,
16% vegetables and cut flowers
70% 21%
15%
60% • Over the past years, a global surge in
14%
50% demand for premium perishables especially
40% from the Americas, EMEA and Asia Pacific
30%
46%
56% • Global consumption for fruits and
20% vegetables segment alone is expected to
10% reach 4.8 trillion euro in 2030. Asia and
0% Oceania will be the main driver behind this
World 2015 World 2030 growth
Asia & Oceania Middle East and Africa Europe Latin America North America
Source: Oliver Wyman

110
Perishables are the main driver of air cargo
Split of perishable products by type

(% share)
• Global perishables are the main driver of air
9%
cargo. Perishable goods transportation
market expect a steadily annual growth of
7.73% from now until 2022
17% • In January 2019, air transport of perishables

increased 6%. Leading forwarders such as
47% Kuehne + Nagel, Panalpina, DB Schenker
and Newport recorded double digit growth
(between 13 – 16%) in the beginning of
2019
27% • Forwarders and carriers now see ‘high value’

perishables as a prime business, as demand
for such premium products increases around
Fruits & vegetables Fish & seafood Flowers Meat the world
Source: WorldACD, Air Cargo News
111
Perishable export and import worldwide
18%* of North
America’s export to
East Asia were
vegetable and animal
products 26%* of European air
Garments and
trade commodities to
perishables were the
More than 70%* of East Asia are
primary commodities
Latin America’s perishables, such as
exported from Middle
northbound goods fish, meat, fruits and
East to Europe
consist of perishables flowers.
Perishables, e-
African air export is
commerce and
dominated by electronic goods are
perishables
growing strongly in
Intra-Asia and
*Data from 2017 Oceania air cargo
markets
Source: Boeing
Ranking of top 10 countries of origin for perishables by air in 2015
1. Kenya
2. India
3. United States
4. Australia
5. Netherlands
6. Egypt
7. Ecuador
8. Colombia
9. Norway
10. Chile
Source: WorldACD
Flow of perishables by air in key markets
UK
Netherlands
USA
Japan
Colombia
Ecuador Kenya
Peru
Fruits & vegetables
Fish & seafood
Chile
Flowers
Source: WorldACD
Content Page

115
Fresh transportation challenges
• Due to the time-sensitive feature of perishable products, from the moment the produce leaves its source, time and
distance are the major challenges faced by the entire fresh supply chain. Fast delivery and efficient coordination
among supply chain stakeholders are the primary objectives
• To preserve the quality and freshness, temperature control is critical– food bacteria grow best between 40 to 140º
F and could double in as short as 20 minutes within this temperature range. Inadequate temperature management
during transit could cause safety issue and spoilage of the produce before reaching the end customer
• Although the carrier might be able to control temperature during transit, in some cases, challenges also occur when
the produce are beyond the shipper’s control – for instance, waiting for custom clearance and inspection at the
holding area
• Transportation of quality control – many fresh products such as eggs are delicate and require specialized
equipment and packaging shipping from the farm to the retailer
• Transportation of perishable involve many stakeholders along the supply chain. Traceability and efficient
communication between different stakeholders during transport lifecycle. Poor communication might result
inventory loss or damage
Source: IATA research
116
From the moment the produce leaves its source, time and distance are the major challenges
faced by the entire fresh supply chain
Time before spoilage for different type of perishable produces
(days)
Fish Strawberry
Due to the time-sensitive feature of perishable products, from the moment the produce leaves its source, time and
distance are the major challenges faced by the entire fresh supply chain.
Fast delivery and efficient coordination among supply chain stakeholders are the primary objectives
117
To preserve the quality and freshness, temperature control is critical
Optimal storage temperature

(ºC)
14 • To preserve the quality and freshness,

temperature control is critical– food
12 Banana, 12 - 16ºC bacteria grow best between 5 to 60º C and
could double in as short as 20 minutes
10
within this temperature range
8
• Inadequate temperature management during
6 Melon, 6 - 9ºC transit could cause safety issue and
spoilage of the produce before reaching the
4
Fish, in melting ice
Lettus, 0 - 2ºC end customer
2 0 to -0.5ºC
• Although the carrier might be able to control
Apple, 0 - 2ºC Dairy, 0 - 2ºC
0 temperature during transit, in some cases,
challenges also occur when the produce are
-2
Fresh meat, -1.5ºC
Poultry, -1.5ºC beyond the shipper’s control – for
Meat product, -2ºC
-4
instance, waiting for custom clearance and
inspection at the holding area
Source: Oxford Journal, IATA research
118
Traceability and efficient communication between different stakeholders during transport lifecycle
Transportation of perishable food
• Transportation of quality control – many

fresh products such as eggs are delicate
and require specialized equipment and
Processing Land Cargo Indoor packaging shipping from the farm to the
facilities transportation terminal transfer retailer
• Transportation of perishable involve many

stakeholders along the supply chain. Poor
Unloading Landing Flight Loading communication might result inventory
loss or damage
Indoor Land Distribution

Customs
transfer transportation center
119
Shippers Expectations in Cold Chain
Modal shift is a reality because shippers need products to maintain integrity and efficacy during
transportation
• Compliance, standardization, accountability and transparency across

the supply chain
• Properly trained stakeholders on regulations and standards
• Adequately equipped facilities throughout the supply chain
• Global certification for handling of Perishable cargo
• Common audit format to minimize the disruptions and increase

effectiveness
• Ability to easily search and identify stakeholders that meet

requirements
120
Content

121
Center of Excellence for Independent Validators
for Perishable Logistics (CEIV Fresh)
Inspired by Shippers, Driven by Industry!

122
Improve together to protect and grow our industry
The solution
The Need
• … for more safety, security and • Develop standards with regulators
efficiency
• Train industry stakeholders on standards and
• … to raise the bar to (re)gain confidence regulation
• … to improve compliance to • Assess operations against standard check list

standards/regulations
• … for independent assessments vs. • Train independent validators on standards

self-assessments and regulations
• … to identify and recognize the best • Certify and then register best players on a
players publicly website
• … to harmonize and reduce the number • Get States recognition to ensure audits are
of audits valid for all
123
Approach of the CEIV programs
EXISTING NEW
1 2 3 4 5
Standards and Training Pre- Validation Re-
Regulations
Regulations and Standards (Recurrent Validation (Audit) & Validation
Training) Assessment Award (Re-Audit)*
• Advocate for globally accepted standards and regulations

• Train instructors on behalf of the airlines, cargo and ground handlers
• Manage the pool of qualified instructors
• Train the Independent Validators to a common standard and validation methodology
• Train operational staff
• Run on-site pre-audits to prepare for validation
• Conduct the validations
• Manage the database of Independent validators
• Manage the database of certified companies
124
Center of Excellence for Independent Validators (CEIV) for Perishable
The CEIV Fresh aims to ensure a higher and more consistent level of Perishable handling
through validations with registered independent validators and instructors
EXISTING NEW
1 2 3 4 5
Standards and Training Pre- Validation Re-
Regulations
Regulations and Standards (Recurrent Validation (Audit) & Validation
Training) Assessment Award (Re-Audit)*
• Advocate for • Develop training • Develop pre- • Manage deployment of • Manage database
globally accepted contents validation validators of validated
standards and • Develop assessment toolkit • Audit documentation, locations and
regulations assessment criteria • Develop a standard processes and operators
• Establish validation for instructors and validation operations consistently • Manage re-
checklist with validators exam methodology and • Manage quality of validation schedule
industry • Train instructors, assessment tool validations
• Establish industry validators and • Follow-up
steering group industry • Award and recognize
stakeholders operators and locations
• Manage database as "CEIV Fresh
of certified certified"
instructors and
validators
125
CEIV Fresh
To ensure the integrity of the product throughout the supply chain
OBJECTIVES
Ensure overall food safety and reductions of loss of Improve handling of Perishable products and raise
products in the air industry. awareness of existing regulations +
standards.
Ensure product integrity
Elevate staff competency levels through efficient and Create a global and consistent certification that
robust training program. industry can rely on.
126
CEIV Fresh Targets
Who does CEIV Fresh target? The supply chain
3 4
Origin
Handlers
1 2 5 6 Destination
Forwarders/Pet
Companies Handlers
Shippers
127
CEIV Fresh Standard
Review, compare against best practice, offer recommendations for change, identify and mitigate
risks, develop implementation plan
Criteria applied Issues tackled

• Quality management • Content of manuals and guidelines
• Personnel • Procedures for Audits
• Training • Procedures for describing packaging
systems
• Documentation
• Acceptance checklist quality and operating
• Infrastructure + equipment
agreements
• Quarantines & complaints
• Packaging requirements
• Supplier management
• Documentation & labeling
• Self-inspections & internal audits
• Acceptance & control
• Transportation
• Facilities and equipment
• Operations
• Staff training requirements
• Training adequacy and currency
128
CEIV Fresh Standard
Compliance vs. non-compliance
IMPORTANT
Non-Conformance Ratings:
MINOR non-conformance – minor or less serious non-conformance which is

unlikely to pose a risk to product quality;
-> need to be closed for the CEIV Certification
MAJOR non-conformance – failure to satisfy a key or mandatory requirement

and/or one which may pose a risk to product quality;
-> need to be acted upon for the CEIV Certification.
Recommendations are provided as suggestions for potential

improvements only and won’t be reviewed for CEIV Certification
129
Content

130
Certification Approach and Methodology
1 3 4
• Assemble team • On-site assessment by • On-site visit by an 5

• Prepare project logistics Independent validator Independent Validator to
Certification
• Assessment versus ensure full compliance with
• Send data and information minimum IATA CEIV Fresh the IATA CEIV Fresh
request Checklist checklist and also review
• Send interview request • Comparison against best the progress made against
sheet for first visit practice recommendations during
• Establish findings and offer the assessment phase
recommendations for • Drafting of report
change
• Develop implementation
plan and secure resources
• Draft gap analysis report
2 6
Additional
131
Successful completion of the courses is essential for certification

certification
Perishable Cargo
Logistics
Management
Successful completion of:

• 2 personal on the “audit” training (3 days).
132
Training
Perishable Cargo Logistics Management

certification
Key topics:
• How to use IATA’s PCR
• Government and airline regulations
• Shipper’s and airline’s responsibilities
• Documentation and labelling
• Perishable handling procedures
• Damage, claims and tracking
• HACCP-based perishable safety
• CEIV fresh audit checklist
✓ 2 personnel per station should be trained on the Classroom course
133
Training Options In-Company vs Training Center

certification
TRAINING IN-COMPANY
CENTER TRAINING
$ $$ Cost
4 12 No. of Participants
Inflexible Flexible Location
134
Assessment
Assessment
Raise awareness On Perishable handling requirements
Assess client To identify potential gaps using the IATA CEIV Fresh checklists

systems

To assist client in achieving "CEIV Fresh Certified" status
and produce report
135
Validation
Validation
Action
• Schedule
• Personnel
• Quantitative
• Qualitative
Implementations

fulfilled.
136
Validation
Validation

report within a timeframe CEIV Fresh registration
of two (2) months. certificate with
immediate effect.
Management Review.
137
Deliverables
• Perishable handling criteria checklist. • Progress report to review the progress made
assumptions, findings, results, conclusions and Fresh certified" based on satisfactory compliance of
recommendations and will specifically: CEIV criteria.
defined CEIV Fresh Handling criteria (e.g. PCR);
138
Additional Training
Introduction to Time and Temperature Perishable Products
Additional Training
4-6 hours training. Key topics:

• Perishable products
• Processes & procedures related to job functions
• Identification and labelling
• Effect of temperature on Perishable products
• Avoidance of counterfeits
• Passive and active packing
• Product security
All personnel involved in handling Perishable products activities per station should
be trained on “IATA Introduction to Time and Temperature Perishable Products
course“ (or equivalent)) within period of 12 months after the “Certification”
139
CEIV Fresh: Path to Certification
In a nutshell
Step 1 Preparation
Step 2 Training
Step 3 Assessment
Step 4 Validation
140
4-6 12-26
weeks weeks
site Timeframe site
depends on
results of
assessment.
Additional
4-12 weeks
12 months
after
assessment.
certification
validation.
141
Perishable shippers demanded to impose timelines


CEIV Fresh 142

CEIV Fresh Caveat
Once a client obtains the CEIV Fresh Certificate, IATA or an IATA representative mandated by
IATA will have the right to conduct spot checks to ensure continuing quality of the certification
IATA notifying the client, then IATA will withdraw its CEIV Fresh registration certificate with immediate effect.
• In order to determine whether a client and/or station that has received the CEIV Fresh Certificate still meets the
satisfactory information within thirty (30) days of IATA notifying the client, then IATA will withdraw its CEIV Fresh
• In order to determine whether a client and/or station that has received the CEIV Fresh Certificate still meets the
satisfactory information within thirty (30) days of IATA notifying the client, then IATA will withdraw its CEIV Fresh
CEIV Fresh 143

Recertification
CEIV Fresh
3 years Max. 2
✓
days
X Close
gaps
Validation
1 - 2 days
REFRESHER TRAINING
144
Content

145
CEIV Fresh – Key Benefits
CEIV Fresh is a win-win situation for the industry
Shippers Airlines, GHAs, Forwarders, Airports

▪ Conduct simpler audits of operators ▪ Protect and grow revenues by gaining stake in the
▪ Obtain guarantee that products would be handled in line growing perishable market
with regulations ▪ Obtain recognition and visibility for operations, facilities
▪ Reduce food loss and waste and staff after meeting standards
▪ Be able to prepare their products ready for acceptance ▪ Experience simpler audits from various organizations
▪ Promote their best practices to the shipper’s community
▪ Speak with one voice
Regulators IATA
▪ Ensure food safety along the supply chain ▪ Disseminate standards in the industry
▪ Access to structured and consistent training ▪ Common audit criteria and global certification
▪ Registry of independent validators and certified ▪ Promote air transport and so limit the modal shift
operators
146
Content

147
Visibility for CEIV Fresh validated entities
Validated entities are visible on IATA’s website
148
Visibility for CEIV Fresh validated entities
New database combining different IATA certifications under one roof – Coming in 2019
Preliminary layout
149
CEIV Fresh (Certified Entities)
Certified Perishable Trade Lanes Development
Locations
3 Certification Completed
Certification in Progress
+1 (estimate)
10 Certification under discussion *

* Estimate
150
CEIV Fresh
Pilot Project Status
▪ Pilot is ongoing to determine the feasibility of CEIV

Fresh
▪ Airline, cargo terminal operator and ground handling

agents involvement
▪ Staff from participating companies being trained
▪ Assessment of organization’s documents, processes,

infrastructure and operations
▪ Final validation ensuring that the findings have been

resolved confirming compliance to the program
requirements
▪ Pilot completion expected by April 2019
151
How to become CEIV Live
Animals Certified
Content
5.1 Introduction: Live animal handling is a competitive and challenging yet

booming and profitable business
5.2 Challenge: CEIV Live Animals is a concerted effort to meet environmental demands
that impact animal’s welfare and comfort
5.3 Objective: CEIV Live Animals is a concerted effort to meet environmental demands
5.6 CEIV Live Animals: Update of activities
153
Live Animal Handling Market Status
Live animals have been transported by air since the early 1930's
Live animals have been transported by air since

the early 1930's. In today's modern world, carriage
of live animals by air is considered the most
Airlines play an important
humane and expedient method of transportation role in this process, offering
over long distances.
the most humane and
Live animals are transported internationally for
expedient way of
many reasons – as livestock, as consumable relocating the animals.
foodstuffs, as pets, for species conservation, etc.
154
Live animal handling is a competitive yet booming and profitable business
Strong business case for Air Cargo
• Live animal transport by air is a competitive business,

estimated at only 1% of all air cargo
• Costs have risen over the years due to:
• Specialized aircraft (e.g. some freighters can
maintain four different climate zones)
• Specialized facilities (e.g. some airline facility
handled 100 million animals including 80 million
tropical fish and 300 tons of worms)
• Specialized personnel
• Rigorous mitigation procedures in case of
emergency
155
Whether it is a family relocating with their pet, or a race horse flying to its next event, or even
pandas to support the preservation efforts many species of animals travel through airports and
expectations about their welfare is a priority
• Types of animals transported by air include (but not limited):
• pets,
• service and emotional support animals,
• race horses,
• farm animals,
• research animals,
• Animals breeding or commercial shipment (non-exotic),
• circus and zoo animals, and
• many other assorted land and marine animals.
• Transporting animals by air is essential because of:
• Speed
• Existing international recognized standards and Regulations
• High level of security for high value animals
Transporting live animals by air is a complex and highly planned operation involving various stakeholders in
the supply chain to ensure that animals always travel in safe, healthy and humane conditions as well as to
meet customer’s expectations.
156
Content
5.1 Introduction: Live animal handling is a competitive and challenging yet booming and
profitable business
5.2 Challenge: CEIV Live Animals is a concerted effort to meet environmental
demands that impact animal’s welfare and comfort
157
Why CEIV Live Animals
Industry feedback is driving improvements
Call for more enforcements and compliance with the Live Animals
Regulations as well as quality services!
✓ Reduce Animal Stress, Injury & Death

✓ Improve Compliance with Standards & Regulations
✓ Raise the professionalism in the industry
• Increase standardization in the handling and transport of live animals in the air freight environment
• Provide proper documentation through better expertise
• Enhance communication between stakeholders
• Ensure specialized personnel with appropriate training
158
Concerns Raised by the Industry
• Non Compliance • Lack of knowledge

(e.g. Crates, and experience from
Equipment, the different • Failure to meet environmental
Facilities) stakeholders demands can impact animal’s
welfare
• Critical issues can lead to

animal death
• Emotional loss can lead to

reputational issues
• Lack of recognition and

• Poor Communication • Need to reinforce transparency on handling
and Information Training capability
sharing Requirements
159
An Airport Cooperative Research Program (ACRP) study revealed there are 6 issues that must be
addressed when dealing with live animals at the airport
Relief Areas
Animal Stress
Training Needs
Reduction
ACRP Findings
Proper
Communication Weather-related
with Shippers/ Matters
Travelers
Proper
Documentation
160
The in-flight environment, thermal environment, handling, airport and en-route environments, are
a few of many factor to be considered for safe transport of live animals.
• Outside air temperature - The higher the air temperature, the more time is required to cool the cargo compartment prior to loading
animals.
• Quantity, size, and type of animal cargo - These factors affect the heat load, moisture, and CO2 in the cargo compartment.
• Airplane environmental systems’ capability and configuration - Auxiliary power unit (APU) and air-conditioning performance
are affected by the ambient air temperature relative to ventilation capability.
• Airplane condition prior to loading animals - Heat soak and preconditioning the cargo compartment both affect the amount of
time required for the compartment to reach the desired temperature.
• Time on ground with loaded cargo - The longer the time that the airplane is on the ground with loaded live animal cargo, the
longer the airplane will be required to cool the cargo compartment to a desired temperature.
• Animal packaging and stocking densities -The longer the time on the ground and the duration of flight, the lower the
recommended density of animals in the cargo compartment.
Failure to meet the environmental demands will impact on the

animal’s welfare, comfort and survivability thereby impacting the
operator’s revenue as well as reputation
161
There are a lot of live animal handling regulations out there
Example of Some of the Entities Involved with Transport of

Live Animals in the U.S.
• The U.S. Department of Agriculture has the Animal Welfare Act

(AWA) and the Animal and Health Inspection Services (AHIS) health
regulations for the transport of animals on either public or private
transport.
• The Centers for Disease Control (CDC) sets standards and

regulations for animals imported into the U.S. including vaccination
requirements, disease testing and quarantine.
• U.S. Customs and Border Protection is responsible for allowing (or

barring) entry of animals arriving in the U.S. The CBP serves as a
clearing agent for the federal government by verifying all shipping and
health documents are in order and that the owner/agent asking for
release is a legitimate entity.
• U.S. Fish and Wildlife conducts screenings at certain airports to

ensure the Convention on International Trade in Endangered Species
(CITES) of Wild Fauna and Flora
• Each state has its own criteria and requirements for USDA or
State Governments veterinarian issued certificates
162
There are a lot of live animal handling regulations out there
International Live Animal Inspection
(Examples)
• Certain countries have very specific and strict

live animal handling regulations:
• Australian National Consultative

Committee on Animal Welfare
• European Union Regulation 1/2005
• UKCAA Guidance on Welfare of Animals

during Transport by Air
163
Content
profitable business
5.3 Objective: CEIV Live Animals is a concerted effort to meet environmental
demands that impact animal’s welfare and comfort
164
CEIV Live Animals
IATA strategy
Strategy Protect the health

and welfare of
animals globally
Promote a uniform Improve animals
approach for the health and welfare
transport of live appropriate risk
animals. management.
Enhance capability of Reinforce trust

modern live animals through transparency
transportation. Strategy and communication.
The strategy includes many steps to improve standards and ensure that they serve their target: the animals
welfare and Health
165
CEIV Live Animals
Objectives
ImproveImprove animal Elevate staff
transportation competency
health of
and
live animals in level through
welfare
compliance with efficient and
appropriate risk
existing regulations robust training
management
and standards. program.
Ensure animal
safety and welfare
Ensure all animals Support andReinforce trust
are transported recognize through
safely and organizations in
transparency and
humanely by air. their compliance with
communication
live animals
regulations.
166
CEIV Live Animals
Who does CEIV Live Animals target? The supply chain

3 4
Origin
Handlers
1 2 5 6 Destination
Forwarders/Pet
Companies Handlers
Shippers
167
IATA combined its own LAR with other local and regional guidelines
IATA GUIDELINES LOCAL + REGIONAL

GUIDELINES
168
CEIV Live Animals: The Standard
CEIV Live Animal Checklist Criteria
Quality Management …  Organization and management

 Key Performance Indicators
Personnel and Training…  Responsible Person

 Training requirements
Documentation…  Infrastructure & Equipment Documentation

 Process Documentation
Infrastructure and equipment…  Premises & Equipment

 IT System, Maintenance
Complaints & Quarantinee  Process implementation
Supplier Management…  Supplier Selection

 Risk Management
Self-inspections…  Process implementation
Transportation …  Information for Road and Air Transport
Operations …  Ground & Tarmac transportation, Acceptance

 Aircraft Loading & Aircraft Unloading
169
Content
profitable business
170
CEIV Live Animals: Project Approach and Methodology
2 3 4
• Assemble team; • On-site assessment by • On-site visit by an Independent
•
Validation
Prepare project logistics; Independent Validator Validator to review progress

• Send data and information • Assessment versus minimum made against recommendations
request; IATA Live Animal Audit during the assessment phase.
• Send interview request sheet for Checklist; • Drafting of report.
5
first visit. • Establish findings and offer • Min 6-8 weeks after the Certification
• 4 weeks before assessment. recommendations for change; assessment.
• Develop report, implementation
plan and secure resources.
1 6
Training required for certification Additional Training
Training
• Prepare logistics for in-house or  Train remaining staff.

register for class room session;
• Conduct training and pass exam.
• Before assessment.
171
CEIV Live Animals: Project Approach and Methodology – Training
Ensure that reminder if the staff also get acquainted in the latest of handling Live Animals

certification
Facts Upon completion participants will be able to…

• Number of instructors: 1 • Manage technical turnaround of aircraft, coordinating resources
• Duration: 3 days and processes
• Class Size: Up to 20 participants • Apply best practices for safety, punctuality and to be
• Venue: Your Office or IATA training centers commercially successful in aircraft turnaround
• Examination and issuance of Certificate of Completion • Understand and apply safety and punctuality aspects of loading
• Design and offer consistent services according to AHM and I-
Who benefits: Live Animals
GOM standards
• Quality manager Transportatio
• Take a leading role in technical ramp teams
• Station manager n
• Company Veterinarian
• Trainer
• … • Marking and labeling
• LAR, Government and CITES regulations • Acceptance + handling of live animals
• Shipper and carrier’s responsibilities • Loading procedures
• Reservation, schedule and routings • Specific handling procedures
• Animal behavior • Animal health and hygiene
• Classification & nomenclature of animals • Airport handling
• Documentation & responsibilities • Shipment of exotic, laboratory and pregnant animals
• Container requirements • Crisis and delay management
Key topics
172
Assessment
Assessment
Raise awareness On Perishable handling requirements
To identify potential gaps using the IATA CEIV Live Animals

Assess client
checklists
systems

To assist client in achieving "CEIV Live Animals Certified" status
and produce report
173
Validation
Validation
Action
• Schedule
• Personnel
• Quantitative
• Qualitative
Implementations

fulfilled.
174
Validation
Validation

report within a timeframe CEIV Fresh registration
of two (2) months. certificate with
immediate effect.
Management Review.
175
Deliverables
• Perishable handling criteria checklist. • Progress report to review the progress made
assumptions, findings, results, conclusions and Live Animals certified" based on satisfactory
recommendations and will specifically: compliance of CEIV criteria.
defined CEIV Live Animals criteria (e.g. LAR);
176
CEIV Fresh: Path to Certification
In a nutshell
Step 1 Preparation
Step 2 Training
Step 3 Assessment
Step 4 Validation
177
4-6 12-26
weeks weeks
site Timeframe site
depends on
results of
assessment.
Additional
4-12 weeks
12 months
after
assessment.
certification
validation.
178
Perishable shippers demanded to impose timelines


179
CEIV Fresh Caveat
Once a client obtains the CEIV Live Animals Certificate, IATA or an IATA representative
mandated by IATA will have the right to conduct spot checks to ensure continuing quality of the
certification
IATA notifying the client, then IATA will withdraw its CEIV Live Animals registration certificate with immediate effect.
• In order to determine whether a client and/or station that has received the CEIV Live Animals Certificate still meets
the criteria, IATA reserves the right to require at any time, submission by the client of all required current
documentation and information relating to the certification for IATA’s review and approval. If the client does not
supply IATA satisfactory information within thirty (30) days of IATA notifying the client, then IATA will withdraw its
CEIV Live Animals certificate with immediate effect.
• In order to determine whether a client and/or station that has received the CEIV Live Animals Certificate still meets
the criteria, IATA reserves the right to require at any time, submission by the client of all required current
documentation and information relating to the certification for IATA’s review and approval. If the client does not
supply IATA satisfactory information within thirty (30) days of IATA notifying the client, then IATA will withdraw its
CEIV Live Animals certificate with immediate effect.
180
Recertification
CEIV Fresh
3 years Max. 2
✓
days
X Close
gaps
Validation
1 - 2 days
REFRESHER TRAINING
181
Content
profitable business
182
Benefits: A win-win opportunity for all stakeholders
CEIV Live Animals ensures compliance with stringent regulations pertaining to live animal
handling and transport demanded by the industry
Competitive advantage Certainty in compliance

with the IATA LAR
Benefits
Reliability and assurance in

Visibility of credible live animal transport
partners in the supply chain operations for customers
and partners
183
Content
profitable business
184
Certified Entities
“Customers will be looking for

end-to-end excellent service which they
HARC certificate handover can appreciate if everyone in
with Alexandre de Juniac
the supply chain has done the
CEIV program”
Tristan Bradfield,

Heathrow Animal Reception Centre
185
(HARC)
“It’s important that our customers know we’re Certified Entities
handling their pets in a very high, regulated and
prescribed manner and they can absolutely be First Airline to be certified
certain that their animal will be cared for. Air Canada

Having achieved a CEIV certification let’s
them know that we are at the top of our
game and at the top of anyone in the
world’s game.”
Tim Strauss, Air Canada Cargo

First Airline to Achieve CEIV Live Animals Certification
CEIV approach, governance, and
organization: A partnership model and
approach tailored to the needs of the
different stakeholders in the value chain
with qualified experts
CEIV Pharma Certification Approach
There are different approaches to obtain certification
Individual Community Coalition
• One company • A group of • A group of

decides to get "CEIV companies at one companies decide to
Pharma Certified“ airport decide to get get "CEIV Pharma
"CEIV Pharma Certified" at several
• One or several Certified" airports to form
stations several “pharma
• Form a “pharma gateways”
gateway”
• Supply chain
• Supply chain approach
approach
188
Project Governance
Everyone in the value chain can participate in the certification process
Project structure - Who is involved and who can participate?
Example (BRU Cargo)
Pharma shippers
Forwarders with pharma focus
Handlers
Truckers
Facilitators
Airlines
Regulators
TTTF
189
Advocacy
Strong emphasis on engaging stakeholder and advocate for endorsement and recognition
WHO? TASK
Industry
• IATA Live Animal and Perishable Board (LAPD) • Approve standards + guidelines
• Time and Temperature Working Group (TTWG) • Approve trainings
Global • WHO • Global Shippers Forum (GSF)
• FIATA • Cool Chain Association • Endorse + recognize
• TIACA • Pharm.Aero standards
Regional
• EU
• Pharmacopeia
• Endorse + recognize
trainings
Local
• Local stakeholder associations
(Shippers, Freight Forwarders, Ground • Endorse + recognize
Handlers, Airlines) trainings
• Local BARs
190
Advocacy
WHO? TASK
Industry
• IATA Live Animal Board • Approve standards + guidelines
• Approve trainings
Global • WTO • FIATA
• TIACA • Endorse + recognize
• ACI standards
• GSF
Regional
• EU
• FDA
trainings
Local
• Local BARs
191
Advocacy
WHO? TASK
Industry
• IATA Live Animal Board • Approve standards + guidelines
• Approve trainings
Global • WHO • FIATA
• TIACA • Endorse + recognize
• CITES standards
Regional
• CDC
• USDA
trainings
Local
• Local BARs
192
CEIV Pharma – Who is auditing/training?
Qualification and management of independent validators
Qualification Management
▪ IATA conducts preliminary ▪ IVs are registered in IATA

interview with candidate to pre- database and available to complete
qualify candidate for training the assessments and validations
▪ IVs must undergo IATA training ▪ Coordination of IVs is managed

by the IATA team for assessments
▪ IVs need to complete trainings and validations
within six months
▪ IV cannot have been in a
▪ IV’s can also become instructors commercial relationship with
but need to undergo the IATA entity to be validated 12 months
Train-the-trainer course (optional) prior to the engagement
193
Organizational Chart
How is CEIV Pharma organized?
Frederic LEGER Laurent DELARUE
Head QM
Ronald SCHAEFER Independent
Validator
Compliance Standards Training

Ronald SCHAEFER Andrea GRUBER Yaniv SORANY
Validators Instructors
Person X Person X
Person Y Person Y
External
194
How is CEIV Fresh organized?
Frederic LEGER Ronald SCHAEFER
Head QM
TBD Independent
Validator

Person X Person X
Person Y Person Y
External
195
How is CEIV Live Animals organized?
Frederic LEGER Ronald SCHAEFER
Head QM
Maria Jitomirski Independent
Validator

Person X Person X
Person Y Person Y
External
196
Transforming Challenges into Success
The importance of partnerships
Thank you
 Ronald SCHAEFER
 [email protected]
 www.iata.org
198

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CEIV Workshop

Bogotá, May 29, 2019

• Learn how IATA’s standards improve the handling of pharmaceutical cargo

• Introduce and provide an update of IATA’s CEIV Pharma Program:

• Introduce IATA’s CEIV Fresh Program:

• Introduce IATA’s CEIV Live Animals Program:

• Seek your input and constructive feedback

Follow the prepared agenda.

• Pricing, including fares, service charges, commissions, etc.

1.0 Introduction: CEIV Introduction, Overview & Next Step 6

1.0 Introduction: CEIV Introduction, Overview & Next Step

1.0 Introduction: CEIV Introduction, Overview & Next Step

Step 1: Implementation Step 2: Dissemination

Industry feedback driving improvements:

The industry usually asks IATA to address

• Cargo Procedures Conferences Management Group Cargo Procedures

• Cargo Services/Agency Conferences

CARGO SERVICES CONFERENCE

Dangerous Live Animals and Cargo Border Cargo Operations

TCR ULDR CIMP & CXML

Live Animal & Perishable Board

Time & Temperature Working Group

2007 2010 2012 2014

Must be affixed to all

2008 2009 2011 2013

Promote animal care and welfare by keeping the

2007 The PCR includes:

▪ Requirements on handling, marking & labeling

▪ Necessary packaging requirements

▪ Information on the necessary documentation required when transporting

▪ A comprehensive classification of 100’s of perishable commodities

• Provides General Container Requirements such as:

IATA Live Animals Regulations (LAR)

• IATA LAR have been adopted by a number of countries as their national

International Organization or Governmental Agencies

Top ten produces in Colombia in 2018

Coal • Crude oil (6.47% of total export market

Ferroalloys • Fresh produces such as bananas and

Major destinations of imports by air in Colombia in 2016

18% Land 7.6%

15% Air 7.8%

Bogota Antioquia Atlantico

Air trade volume in South America in 2017

• In 2017, Colombia has the largest size

Pharmaceutical market share in Colombia by company in 2017

Import of medical products by origin continent in 2017

Export to Colombia by mode of transportation in 2017

Source: Pharmaceutical Commerce

Commodities transported by air from Latin America to North

Fish • Flowers (27.2%)

Fruits and vegetables • Fish (25.6%）

Source: Boeing, flexport

Top ten produces in Colombia in 2017

Oil palm fruit • Fresh produce exports in Colombia is

Rice, paddy • Fresh fruits with the most growth

Source: FAOSTATS, Oxford Business

North America 2,727.5 United States 2,490

Europe &Central Asia 2,090.7 Belgium 412

East Asia& Pacific 498.6 Netherlands 406