SMi Group's Pharmaceutical Cold Chain Distribution conference & exhibition
1. “In general, a very well organised event.
Professional team and well executed” EVENT ATTENDEE 2013
SMi Presents the 9th Annual Conference on… 2nd - 3rd
DEC
2014
Cold Chain Distribution
Enhance Temperature Management for
an Efficient Supply Chain
Cheryl Blake, GDP Inspector, MHRA
Alan Dorling, Global Head - Pharmaceutical & Life
Sciences, IAG Cargo
Andrea Gruber, Senior Manager, Specialised Cargo,
IATA
Tony Wright, Managing Director, Exelsius Cold Chain
Management
Marriott Regents Park Hotel, London, UK
KEY SPEAKERS INCLUDE:
• David Spillett, Business Development Manager,
Biopharm Services, World Courier
• Tim Wood, Technical Service Manager, GSK
• Gianpiero Lorusso, Supply Chain Manager, Merck Serono
• Michelle Goodyear, QA Manager, AbbVie
• Chris Wallace, Distribution Director, Genzyme
• Didier Basseras, Vice President Global Head of Clinical Supplies
and Supply Chain, Sanofi Aventis R&D
• Thomas Grubb, Manager, Cold Chain Strategy, American Airlines
Benchmark and reflect on the implementation of the GDP
directive with case studies from IATA, AbbVie and the Dutch
Health Care Inspectorate
Enhance your understanding of the challenges of transport
qualification for temperature sensitive pharmaceutical
products with a round table discussion led by Tony Wright,
Managing Director, Exelsius Cold Chain Management and
an opening address from Alan Dorling, Global Head -
Pharmaceutical & Life Sciences, IAG Cargo
Strengthen your supply chain through management and
efficiency insights from Merck Serono and Genzyme
• The Saudi FDA
• The Blood Transfusion
Centre of Slovenia
• plus many more…
@SMIPHARM
Lead Sponsor:
Sponsored by:
Current attendees include:
• AAH Pharmaceuticals
• Allergan
• Alliance Healthcare
• Eli Lilly
CHAIRS FOR 2014:
BUSINESS BENEFITS FOR 2014:
a TCP Company
• F. Hoffmann-La Roche Ltd
• Mundipharma
• Priority Freight LHR Ltd
• Public Health England
• Roche Pharmaceuticals
• Sanofi-Aventis
• Takeda Pharma
International
www.coldchain-distribution.com
BOOK BY 30TH SEPTEMBER 2014 TO RECEIVE £300 OFF
BOOK BY 31ST OCTOBER TO RECEIVE £100 OFF
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
2. Cold Chain Distribution
Day One | Tuesday 2nd December 2014
8.30 Registration & Coffee
9.00 Introductory Icebreaker
9.05 Chair's Opening Remarks
Tony Wright, Managing Director, Exelsius Cold Chain
Management
REGULATORY UPDATES AND IMPLEMENTATION
OPENING ADDRESS
9.10 GDP compliance – A UK regulatory perspective
PART
ONE
•Ensuring qualification and validation over the life cycle of the
product and process
•Enhancing a quality risk management approach
throughout the lifecycle of a medicinal product
•Taking steps towards ensuring standardisation and
harmonisation of regulatory guidelines
Cheryl Blake, GDP Inspector, MHRA
9.50 Assessing inspection results based on the GDP guidelines
•What does the survey symbolise one year after the GDP
guidelines
•What’s being implemented well and what areas
could be improved on?
Riekert Bruinink, Member of GDP Drafting Group,
Dutch Health Care Inspectorate
10.30 Morning Coffee
11.00 Case Study: Handling bulk vaccine product
•An overview of Public Health England
•How to handle a bulk vaccine product through its initial
storage and transport to a contract filler
•Onto the contract packer, finishing up with the final
product - with all the validation, bespoke vehicles
and controls in between and throughout
Mark Riches, Logistics Manager, Public Health England
11.40 Case Study: The Implementation of regulatory requirements
(GDP, IATA, etc.)
•Since the introduction of the GDP Guidelines, where are we now?
•What challenges are being faced to ensure compliance to
the existing regulations (GDP, IATA, etc.)?
•How to elevate pharmaceutical product handling
globally?
•How can we ensure transparency of supply chain
logistics’ partners?
Andrea Gruber, Senior Manager, Special Cargo, IATA
12.20 ROUND TABLE DISCUSSION
Transport qualification for temperature-sensitive
pharmaceuticals & life science products
•Guidelines under EU 343/01
•The 3 ‘P’s’ of transport qualification
•Qualification as an on-going process
Leader: Tony Wright, CEO, Exelsius
Cold Chain Management
1.00 Networking Lunch
ENHANCING SUPPLY CHAIN EFFICIENCIES
KEYNOTE ADDRESS
2.10 Case Study: Supply Chain Efficiency
•Ensuring efficient transport solutions within clinical operations,
distribution and the supply chain
•Streamlining processes and customer supplier relations
•Future requirements to review - What’s new and how
can we move forward?
Didier Basseras, Vice President Global Head of Clinical
Supplies and Supply Chain, Sanofi Aventis R&D
2.50 Developing a dedicated and GDP certified pharmaceutical and
healthcare logistics airfreight gateway in Luxembourg
•Understanding the needs of the pharmaceutical and
healthcare industry
•Complying with airfreight requirements
•Luxembourg case study: creating a fully GDP
compliant and certified end-to-end temperature-controlled
supply chain solutions according to the
latest WHO and EU GDP guidelines
Daniel Liebermann, Director, Directorate Logistics,
Ministry of Economy, Luxembourg
3.30 Afternoon Tea
4.00 Challenges faced with complex supply chains, today's novel
innovations are the supply chain challenges of tomorrow
•Assessing global supply chain trends and novel distribution
strategies
•Strategies to adopt for mitigating risk
•The dangers of shipping between international markets
David Spillett, Business Development Manager, Biopharm
Services, World Courier
4.40 The Implementation of the new GDP guidelines using real life
experiences and examples
•GDP -18 months down the line, where are we now?
•What challenges are being faced to ensure compliance to
the GDP guidelines?
•How can we ensure transparency of supply chain
logistics?
•Likely future challenges and potential developments
Chris Wallace, International Supply Chain Lead, Genzyme
5.20 Chairman's Closing Remarks and Close of Day One
7.30 Dinner at Gordon Ramsay’s Maze Restaurant sponsored by:
Want to know how you
can get involved?
Interested in promoting your
services to this market?
Contact Julia Rotar,
SMi Marketing
on +44 (0) 207 827 6088 or
email: jrotar@smi-online.co.uk
Tuesday 2nd December
Evening Dinner
World Courier will be hosting a unique and exciting
evening dinner at the end of Day 1. This event will
be hosted at Gordon Ramsay’s Maze Restaurant
and the Routemaster will pick up from the Marriott
Regents Park at 7.30pm. It promises to a fantastic
experience. Places are strictly limited, visit our
website for further details.
Register online at: www.coldchain-distribution.com • Alternatively fa
3. Day Two | Wednesday 3rd December 2014
12.20 Networking Lunch
1.20 Chair’s Afternoon Opening Remarks
Alan Dorling, Global Head- Pharmaceutical & Life Sciences,
IAG Cargo
ROUND TABLE DISCUSSION
1.30 Balancing distribution risks with product stability
and cost of delivery
•Risk management and the use of temperature controls in
distribution: should cost be a consideration?
•Assessing innovations to make the distribution process more
efficient and cost effective
•How well has our industry managed the challenges so far?
•The EU GDP one year on: The regulatory perspective
Leader: Stephen Mitchell, QA Manager, Quality &
Compliance, Logistics, GSK
KEYNOTE ADDRESS
2.10 Strengthening the supply chain through your supply chain
management
•Analysing risk management in the supply chain through
contingency planning
•Assessing the impact of global regulations challenging
supply chains
•Discussing supply chain visibility to ensure integrity
Gianpiero Lorusso, Supply Chain Sr Manager,
Merck Serono
2.50 The risk based approach - Verifying transportation to
enhance distribution
•Risk Analysis of the shipment routes to comply with the GDP
guidelines
•Risk mitigation in temperature controlled transport
•Assessing the impact of conditions other than temperature
during transportation
Tom Grubb, Manager, Cold Chain Strategy,
American Airlines Cargo
3.30 Chair's Closing Remarks and Afternoon Tea
Supported by
8.30 Registration & Coffee
9.00 Chair's Opening Remarks
Andrea Gruber, Senior Manager, Special Cargo, IATA
TEMPERATURE MANAGEMENT AND MONITORING
OPENING ADDRESS
9.10 Challenges in air-freighting time & temperature sensitive
shipments across a global network
•What has been the impact of the new EU GDP Guidelines
for air cargo operators?
•Building a vertical team for managing Time & Temperature
air-freight shipments
•Achieving Quality & Compliance across a global network
•Maximising service performance through
collaboration
Alan Dorling, Global Head- Pharmaceutical
& Life Sciences, IAG Cargo
9.50 A portfolio matrix approach to Temperature Control
Packaging - maximum protection at lowest possible costs
•Matching your choice of TCP solutions to the shipping lane
dynamics
- Thermal Stress requirements and associated solution
scoring
- Dynamics of conditioning,
packing and shipping
- Re-capture / Re-use opportunities
- Waste / end of life system options
•Overcoming hurdles to effective re-use
•Alternative options for TCP financing
(own, lease, rent)
Richard Wood, Design Manager, Cool Logistics
10.30 Morning Coffee
ROUND TABLE DISCUSSION
11.00 Temperature monitoring of non-cold chain IMP
shipments
•What are the current evolving regulations?
•The auditing process - experiences about non-cold
chain monitoring
•Introducing temperature controlled shipping
•Facing the challenges with the introduction of temperature
monitoring for all non-cold chain IMP shipments
•How will the overhead of monitoring affect the landscape
for R&D
•How do we ensure consistency internally and externally at sites?
Leader: Tim Wood, Technical Service Manager, GSK
GDP IMPLEMENTATION AND RISK MITIGATION
11.40 Case Study: The implementation of the new
GDP guidelines
•Implementation of the GDP guidelines and
integrating this into the strategy and procedure
•What challenges are being faced to ensure
compliance of the GDP guidelines?
•How can we ensure transparency of supply
chain logistics
Michelle Goodyear, UK Quality Manager, AbbVie
Platinum Media Partner
PART
TWO
Silver Media Partner
ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
4. Cold Chain Distribution
Tuesday 2nd and Wednesday 3rd December 2014
Lead Sponsor:
World Courier
Incorporated in 1969, World Courier is the leader in specialty logistics for global clinical trials delivering fully-integrated GxP-compliant
temperature-controlled transport, storage and distribution solutions worldwide in over 10.000 clinical studies. World
Courier has a network of over 150 company offices operating in more than 50 countries plus a network of 13 x GMP compliant
storage depots in strategic locations.
Through its company-owned network of offices World Courier provides door-to-door, customs-cleared service to more than 220
countries and territories and setc the benchmark for temperature controlled, time sensitive transportation.
As Cold Chain shipments face increased scrutiny from internal bodies and international agencies alike, strict adherence to
temperature control is critical for compliance with international regulatory, manufacturing and safety standards. With our
proven track record in Cold Chain Management, World Courier is the only specialty logistics provider that offers comprehensive
and customized temperature-controlled transportation services 24/7/365 worldwide.
www.worldcourier.com
Who should
attend this
conference:
You should attend this event if
you work in the Pharmaceutical
Industry with responsibilities in
Quality Assurance, Quality
Compliance, Regulatory, Supply
Chain, Manufacturing, Packaging,
Distribution, Operations.
Job titles include:
• GMP Compliance Specialist
• GMP Inspector
• Director, Global Demand
Planning & Customer Operations
• Director, Purchasing and
Distribution
• General Manager, Distribution
and Logistics
• Director, Regulatory Affairs,
Corporate GMP Officer
• Head of Packaging
• VP, Clinical Logistics
• International Supplies Manager
• Quality Assurance and Quality
Compliance Manager
• Head of Corporate Supply Chain
Operations
Cold Chain Distribution Attendees
2011-2013 by Industry Sector
PHARMACEUTICAL
51%
ACADEMIA 7%
REGULATORY 9%
SERVICES/PRODUCT
SUPPLIERS 33%
Cold Chain Distribution Attendees
2011-2013 by Region
UK AND EUROPE 90%
MIDDLE EAST 6%
USA 4%
• DISTRIBUTION • GDP COMPLIANCE • TEMPERATURE MANAGEMENT • SUPPLY CHAIN EFFICIENCY •
5. Cold Chain Distribution
Tuesday 2nd and Wednesday 3rd December 2014
AmSafe Bridport
Globally renowned, AmSafe Bridport supports air cargo logistics around the world with its industry-tested range of
DuPont™ Tyvek® Thermal Cover solutions, specifically designed to protect all types of temperature sensitive products,
reduce freight volumes, aid quick handling and be Good Distribution Practice (GDP) compliant - key requirements for
the pharmaceutical supply chain. http://amsafebridport.com
Berlinger & Co.
Berlinger & Co. AG is a leading Swiss manufacturer of temperature monitoring systems. For more than 25 years,
Berlinger & Co. AG provides the industry with reliable and easy to use temperature indicators. With our online data
management & central monitoring solution “smartview“, you can optimize your workflow and automate process
steps. All our systems are WHO/UNICEF approved. www.berlinger.ch
Cryopak
Cryopak designs and manufactures complete cold chain packaging solutions from fabricating insulated boxes or
cool refrigerants to manufacturing phase change materials and temperature monitors. From needs assessment to
package qualification, Cryopak handles your packaging projects with one paramount goal : bringing you our
expertise to maintain the integrity of your products. www.cryopak.eu
ELPRO Company Profile
ELPRO, founded in 1986, is a globally active provider of solutions for monitoring environmental conditions throughout
the supply chain of perishable goods. While the focus is on pharmaceutical, healthcare, biobanking & life-science
industry, ELPRO serves a wide range of industries. Whenever temperature, humidity, pressure, or any other
environmental condition is key to the quality of products during production, storage or transport: ELPRO cares for
efficiency and compliance. Monitoring means to measure, record, and manage data and – based upon stability
criteria – assess the data for release or alarm. www.elpro.com
The Movianto Group
The Movianto Group is the preferred European supply chain partner for the healthcare industry, with its network of
wholly owned subsidiaries in 11 countries. Our services include: warehousing, transport solutions, repackaging and
relabeling services, controlled drugs, clinical trials and samples management. www.movianto.com
Testo
Testo instruments are the solution for every application, whether it is in laboratories, cleanrooms, storage, transport or
the health sector. Testo will be showcasing their range of Data Loggers, including the brand new Testo 184 Logger and
Saveris Data Monitoring System, which is especially suited for the transportation of pharmaceuticals.
www.testolimited.com
Sensitech Inc.
Sensitech Inc. is a leading provider of supply and cold chain visibility solutions that enable our customers—global
leaders in the food, life sciences and industrial markets—to track, monitor and protect the quality and integrity of their
temperature-sensitive products across complex supply chains. Through its logistics security division, FreightWatch
International, Sensitech also offers origin-to-destination services that provide customers with real-time cargo
transparency, helping them to mitigate such risks as theft, diversion, counterfeiting, and chain of custody. Sensitech
Inc. is an ISO 9001:2008 company based in Beverly, Mass., with more than 30 sales, service and distribution locations
around the world. Sensitech is a part of UTC Building & Industrial Systems, a unit of United Technologies Corp., a leading
provider to the aerospace and building systems industries worldwide. www.sensitech.com
Peli Cool Logistics
Peli Cool Logistics specialises in the supply, design, test and qualification of temperature controlled packaging solutions
and is dedicated to meeting the complex needs of the global Healthcare Industry. Customers benefit from their
extensive expertise in ensuring that temperature stability is maintained throughout the distribution chain. Diverse
industry needs are recognized and the challenges that different geographical regions present are taken into account.
The product range includes everything from dry-ice shippers, chilled and room temperature solutions around the high
performing re-usable CREDOTM shipping systems, single use SHERPA™ and recently released CHRONOSTM Advance
high performance ranges in addition to their bulk freight forwarding COOLPALL™ products. Off-the-shelf solutions,
customized designs and other third party solutions are also available, as well as a variety of sizes from small mailers to
pallet accepting shippers. www.cool-logistics.com
Sponsors/Exhibitors:
a TCP Company
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company's marketing strategy.
Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific
to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick,
Director on +44 20 7827 6168 or email: amalick@smi-online.co.uk
6. COLD CHAIN DISTRIBUTION
2ND - 3RD DECEMBER 2014 | MARRIOTT REGENTS PARK, LONDON, UK WORKSHOP: MONDAY 1ST DECEMBER 2014, LONDON
4 WAYS TO REGISTER
www.coldchain-distribution.com
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor
South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
Unique Reference Number
Our Reference LVP-124
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Terms and Conditions of Booking
Payment: If payment is not made at the time of booking, then an invoice will be issued and must be
paid immediately and prior to the start of the event. If payment has not been received then credit
card details will be requested and payment taken before entry to the event. Bookings within 7 days
of event require payment on booking. Access to the Document Portal will not be given until payment
has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send a
substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing
that cancellation is made in writing and received at least 28 days prior to the start of the event.
Regretfully cancellation after this time cannot be accepted. We will however provide the
conferences documentation via the Document Portal to any delegate who has paid but is unable
to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to
provide documentation in these circumstances. We cannot accept cancellations of orders placed
for Documentation or the Document Portal as these are reproduced specifically to order. If we have
to cancel the event for any reason, then we will make a full refund immediately, but disclaim any
further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
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□ Book by 30th September 2014 to receive £300 off the conference price
□ Book by 31st October 2014 to receive £100 off the conference price
EARLY BIRD
DISCOUNT
CONFERENCE PRICES
I would like to attend: (Please tick as appropriate) Fee Total
□ Conference only £1499.00 +VAT £1798.80
REGISTRATION INCLUDES FREE ATTENDANCE AT (PLEASE TICK)
□ End of Day Evening Dinner at Gordon Ramsay's Maze Restaurant
(2nd December)
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
The conference fee includes refreshments, lunch, conference papers, and access to the
Document Portal. Presentations that are available for download will be subject to
distribution rights by speakers. Please note that some presentations may not be available
for download. Access information for the document portal will be sent to the e-mail
address provided during registration. Details are sent within 24 hours post conference.
LIVE STREAMING/ON DEMAND/ DOCUMENTATION
Unable to travel, but would like to watch the conference live, ask questions,
participate as if you were in the room. Price Total
□ Live Streaming £999.00 + VAT (UK) £1198.80
□ On demand £599.00 + VAT (UK) £718.80
(available 24 hours after the event)
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
□ The Conference Presentations - paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
PAYMENT
Payment must be made to SMi Group Ltd, and received before the event, by one of
the following methods quoting reference P-124 and the delegate’s name. Bookings
made within 7 days of the event require payment on booking, methods of payment
are below. Please indicate method of payment:
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VAT
VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on live
Streaming, on Demand, Document portal and literature distribution for all UK customers and
for those EU Customers not supplying a registration number for their own country here.
______________________________________________________________________________________________
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk