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“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
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
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
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 •
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
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 
DELEGATE DETAILS 
Please complete fully and clearly in capital letters. Please photocopy for additional delegates. 
Title: Forename: 
Surname: 
Job Title: 
Department/Division: 
Company/Organisation: 
Email: 
Company VAT Number: 
Address: 
Town/City: 
Post/Zip Code: Country: 
Direct Tel: Direct Fax: 
Mobile: 
Switchboard: 
Signature: Date: 
I agree to be bound by SMi's Terms and Conditions of Booking. 
ACCOUNTS DEPT 
Title: Forename: 
Surname: 
Email: 
Address (if different from above): 
Town/City: 
Post/Zip Code: Country: 
Direct Tel: Direct Fax: 
VENUE Marriott Hotel Regents Park, 128 King Henry's Road, London, NW3 3ST 
□ Please contact me to book my hotel 
Alternatively call us on +44 (0) 870 9090 711, 
email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712 
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. 
Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection 
Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other 
products and services. Unless you tick here □we may also share your data with third parties offering 
complementary products or services. If you have any queries or want to update any of the data that 
we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit 
our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the 
attached letter. 
□ 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: 
□ UK BACS Sort Code 300009, Account 00936418 
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU 
Swift (BIC): LOYDGB21013, Account 00936418 
IBAN GB48 LOYD 3000 0900 9364 18 
□ Cheque We can only accept Sterling cheques drawn on a UK bank. 
□ Credit Card □ Visa □ MasterCard □ American Express 
All credit card payments will be subject to standard credit card charges. 
Card No: □□□□ □□□□ □□□□ □□□□ 
Valid From □□/□□ Expiry Date □□/□□ 
CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card 
Cardholder’s Name: 
Signature: Date: 
I agree to be bound by SMi's Terms and Conditions of Booking. 
Card Billing Address (If different from above): 
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

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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 DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: VENUE Marriott Hotel Regents Park, 128 King Henry's Road, London, NW3 3ST □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712 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. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. Unless you tick here □we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter. □ 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. 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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