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« Cold Chain Logistics – Outstanding cold chain management based on
an owned network, high quality standards and qualified packaging »

Sebastien PRADAL
Sales Manager France
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Agenda

• Pharmaceutical market overview

• Optimization of the transit time using assessed

airlines

• Harmonization of packaging through an extensive

network

• Real time tracking system, temperature follow up

and customs
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Novel Therapies and Innovations
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New Challenges and Requirements
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What could possibly go wrong?
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Enhanced Expectations of the Cold Chain Logistics

Increased
Regulation
Temperatures
Therapies Precise
Novel
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Optimization of the transit time using assessed airlines

• Audit performed on a scheduled basis in conjunction with

performance review on all airlines.
• Transportation routes should be clearly defined. Seasonal and
other variations should also be considered during verification
of transport.
• A risk assessment should be performed when changes or new
processes.
• Using the IATA Time and Temperature Sensitive Label to
reduce error throughout the global supply chain.
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Harmonization of packaging through an extensive network

Dedication : Case study examples

In the danger zone: In 2014, World Courier’s Leipzig office was supporting a global cell “
If there were any delays
therapy clinical trial, of which there were several sites located in the Ukraine, with and the transport company
three patients located in Donezk. The trial coincided with the outbreak of the had trouble locating a
Ukrainian-Russian military conflict. World Courier had a plan when no other logistics shipment, if the starting
carrier could find one. The team in Kiev assigned dedicated drivers who successfully material arrived too late at
delivered a sum of 16 medications shipments in dry shippers with no delays or the facility, it might have
temperature excursions – all while navigating a zone of on-going military conflict. The been too late to
last shipment was delivered in October 2014, when Donezk airport was closed and manufacture the product
shelled since May 2014. and a cancer patient might
Working outside the box: As a part of our supporting a phase III clinical trial, World not have received the drug.
Courier’s in-house packaging experts explored a number of solutions, eventually That's why we decided to
selecting an industry-leading active container with dry ice as coolant. However, the work with World Courier,
packaging provider had no units available at the airport for a shipment that had because it was so
already been booked, meaning a potential — and unacceptable — delay in product
delivery. When the packaging provider was unable to deliver replacement units, World
important. ”
Courier’s in-market, high-touch specialists quickly located alternative equipment that World Courier Client
could be prioritized and available at the airport next-day.
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Harmonization of packaging through an extensive network

• An own network well trained to comply with good

practices’ guidelines
• Local contact for local language
• 24h/7days a week/365 days a year assistance
• No jetlag communication issue
• Be able to intervene in case of any problems
• Provide qualified packaging all over the world in
timely fashion
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Vital Considerations

Study Specific
Training Technical & Quality

SOPs AT
All Levels SLAs
Airline Buy In Transport Plan
and Understanding Recommended airports and airlines — use
data including hours of operation, lockout
Certificated Airports, and recovery and performance for analysis
Latest pick Best transport
Hand Searches up times mode
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Harmonization of packaging through an extensive network
Evolution of Thermal Packaging
The introduction of passive solutions in 2004 changed the temperature control
landscape forever. Recent developments focused on reducing weight and cost

Passive Passive
Semi-Active Passive “Light”
Container Multi-Use
ATC, ETC VIP Family GTC Cocoon

• *Honeycomb*
• Vacuum Insulated • Vacuum Insulated
• Styrofoam Panel Vacuum Insulated
Panel Panel
Panel
• Water-based
• PCM • PCM • PCM
Gel Packs
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Harmonization of packaging through an extensive network

Global Packaging Systems

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Harmonization of packaging through an extensive network

Qualification and Validation of Packaging

Introducing CORE Labs, a new center of excellence that combines collaboration,

expertise and evidence-based data to provide optimal packaging solution
recommendations to manufacturers and other shippers of temperature-sensitive
materials.
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Harmonization of packaging through an extensive network

The future of qualification.

• Test and validate all types of packaging under a host of

conditions

• Replicate a range of extreme temperatures

• All 3 internal ranges at both ISTA summer and winter
configurations
• Accommodate up to three full-sized pallet loads side-
by-side comparative testing
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Real time tracking system, temperature follow up and customs

§ Relevant technology è optimal product handling and successful time

delivery

ü Temperature loggers
ü Monitoring innovations (GPS/GSM technology)
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Real time tracking system, temperature follow up and customs

§ Customs è be diligent with the required documentation

Ensure that all paperwork is correct
Make sure that permits are in place
Ensure that the importer of record is prepared

§ If your company doesn’t have the internal skills, you can use a
logistics partner with its own broker
Direct relation with local customs
Administrative support
Anticipation of customs

è No delay of delivery, minimize the risk of temperature excursion

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Your checklist

§ Have you chosen a logistics partner that:

Can proactively plan and manage your route, including an

investigation of the airports and facilities ?
Can support you to choose and test the correct packaging for your
shipment ?
Can make use of the relevant technologies for monitoring and
tracking?
Adhere to GxP standards and GMP guidelines ?
Can ensure that all the correct customs documentation and permits
are in place ?
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