3rd - 4th DECEMBER 2012 MARRIOTT REGENTS PARK, LONDON, UK PLUS A SITE VISIT TO A WORLD COURIER SITE

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1 "Insightful & Informative" Eisai Ltd SMi PRESENTS THE 7TH ANNUAL CONFERENCE COLD CHAIN EARLY BIRD DISCOUNTS: BOOK BY SEPTEMBER 28TH SAVE 100 DISTRIBUTION EUROPE'S PREMIER EVENT 3rd - 4th DECEMBER 2012 MARRIOTT REGENTS PARK, LONDON, UK KEY SPEAKERS INCLUDE: Sue Lee, Regional Quality Manager UK, Ireland, Middle East & Africa, World Courier Yoram Eshel, Senior Director, Global Transportation & Logistics, Teva Pharmaceuticals Frank Reale, Associate Director, Global Regulatory Operations, Global Regulatory Strategy, Policy & Safety, Merck & Co. Stephen Mitchell, QA Manager, Quality & Compliance, Logistics, GlaxoSmithKline Mathieu Materne, Global IT Validation Coordinator, UCB Pharma Ian Holloway, Manager of the Defective Medicines Report Centre, MHRA Eric Devin, Development Managing Director, Cemafroid KEY REASONS TO ATTEND: Learn how to improve efficiency of your cold chain whilst still maintaining quality and cost-effectiveness Discuss the latest innovations in the industry, both at the event and in the new SMi event communities, where all participants of the event will have a chance to network, debate and discuss the industry Hear about Good Distribution Practices in the industry and how they can be applied to all aspects of the cold chain distribution process to create a smooth transition in each stage of transport Explore the methods to distribute pharmaceuticals effectively throughout the globe, and to even the most remote of areas Listen to presentations from members of the industry at the forefront of innovation and development and hear their views on the latest technologies, management techniques and cold chain strategies PLUS A SITE VISIT TO A WORLD COURIER SITE December the 5th 2012, The World Courier Heathrow site The site visit will feature a World Courier ground temperature controlled cube and trailer demonstration and presentations by Mark Bishop, UK Sales & Marketing Director and Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier Lead Sponsor Sponsored by Register online or alternatively fax your registration to +44 (0) or call +44 (0) SAVE 100 when you book by September 28th

2 Interesting and insightful, has provided much food for thought, Roche Products Ltd DAY ONE MONDAY 3RD DECEMBER Registration & Coffee 9.00 Chairman's Opening Remarks Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier COLD CHAIN REGULATIONS AND AUDITING KEYNOTE ADDRESS: 9.10 The logistics of providing cold chain investigational clinical supplies in a global environment How "Not So Apparent Regulations" impose hurdles and roadblocks for the safe and timely delivery of Investigational Clinical Trial material. Country specific regulations that can be imposed that are specific to any given country Regulations on investigational clinical supplies: the differing commercial material and potential delays, detentions, seizure of material and possible destruction Understanding these regulations to ensure timely and safe delivery of material Frank Reale, Associate Director, Global Regulatory Operations, Global Regulatory Strategy, Policy & Safety, Merck & Co Current and Future Regulation of Cold Chain products Current GDP Guidelines and cold chain distribution Revision of Annex 16 of the GMP Guide and likely impact on cold chain operations Security within the supply chain and the Falsified Medicines Directive Ian Holloway, Manager of the Defective Medicines Report Centre, MHRA Morning Refreshments LATEST TECHNOLOGIES AND TRANSPORT INNOVATIONS A Sensitech perspective on Cold Chain Senior representative, speaker to be confirmed A chemistry-based device with on-off switches for the profiling of temperature during cold-chain distribution Background to the TSB-funded research and development project A survey of various existing chemistry-based temperature monitoring devices The importance of on-off switches in monitoring devices Novel chemistry-based device with on-off switches Long Lin, Professor of Colour & Polymer Science Research, University of Leeds Afternoon Tea Energize the Chain: Bringing Vaccines to the Most Remote Parts of the Globe Statement of the problem: The cold chain degrades the further away from the central storage points in the developing world The extent of the problem: 2.5 million children die of vaccine preventable causes The solution to the problem: Utilize energy available at cell towers sites to power vaccine refrigeration units even in the most remote parts of the world Implementation: Public private partnerships organized through our non profit organization--energize the Chain Examples of implementation: Zimbabwe and other countries. Harvey Rubin, Professor of Medicine, University of Pennsylvania The auditing of a transport company Understand the audit process for transport companies and know what to focus on. Identify key audit criteria to ensure operational conformity and optimum results. Consider the regulatory requirements and how to streamline these with transport options. Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier Panel Discussion: Perspectives and opinions on auditing in cold chain distribution Speakers from the event will discuss auditing in the cold chain industry; they're thoughts and opinions Delegates will be able to put forward questions for the panel on the auditing process The panel discussion will feature a selection of speakers from across the 2 day event Frank Reale, Associate Director, Global Regulatory Operations, Global Regulatory Strategy, Policy & Safety, Merck & Co Networking Lunch Control Temperature processes along the supply chain CRT Vs. Ambient do they really maintain the required temperature? The current paradigms about controlled temperature shipments. How CRT shipments look like in real life? How to practically mange your controlled temperature transportation Yoram Eshel, Senior Director, Global Transportation & Logistics, Teva Pharmaceuticals Chairman s Closing Remarks Close of Day One Drinks Reception: Sponsored by World Courier The first day of the conference will be followed by a Networking Dinner at the Gilgamesh Restaurant; available for pharmaceutical companies Hosted by World Courier, this will allow for networking and discussion of the cold chain industry in a more informal setting Register online at Alternatively

3 Productive conference Pfizer DAY TWO TUESDAY 4TH DECEMBER Registration & Coffee 9.00 Chairman's Opening Remarks Tony Wright, CEO, Exelsius IMPROVING COLD CHAIN EFFICIENCY AND LOGISTICS KEYNOTE ADDRESS: 9.10 The Management of Logistics Risks in the Pharmaceutical Supply Chain Understanding the pharmaceutical supply chain Identifying and assessing risks before and during the supply chain process Mitigating risks as effectively as possible Resources to help all companies improve their supply chain process: with specific cold chain examples Stephen Mitchell, QA Manager, Quality & Compliance, Logistics, GlaxoSmithKline 9.50 Increasing the efficiency of current systems available The efficiency of IT systems in the transport process Assessing the need for change, and assessing the areas in which change is needed Implementation of changes throughout the entire logistic process How change can cause problems, and how to stop reduction in quality Mathieu Materne, Global IT Validation Coordinator, UCB Pharma Morning Refreshments Understanding and analysing Cost of Quality (CoQ) Understanding the difference between Quality Assurance and Quality Control. Current regulatory thinking on managing quality. The Cost of Quality Model: assessing the cost of quality for internal and external activities for prevention and appraisal. Managing cost of quality to achieve best operational value. Robert J Hayes, Director, Cold Chain Consultants (UK) Ltd Achieving traceability based on GS1 Standards Overview of important regulatory and industry developments GS1 Standards for Healthcare: Process and technical ( Identify, Capture, Share ) standards The Global Traceability Standard for Healthcare (GTSH) Examples of successful implementations of standards Janice Kite, Traceability Director Healthcare, GS1 Global Office Afternoon Tea ENSURING QUALITY OF PRODUCT THROUGHOUT SUPPLY Choosing an adequate temperature measurement procedure and device to insure a declaration of conformity without unknown risk The theorical basis of uncertainties, the impact on the validity of a declaration of conformity and its consequential interference on the true temperature of medical products Cold chain distribution in resource-poor countries Outsourcing clinical trials in resource-poor countries The regulations in different countries and how this affects the cold chain process Maintaining the cold chain for drug shipments: tools and techniques Maintaining the cold chain for sample transfer The eventual outcomes of the supply chain, and an example of a cold supply chain in a resource-poor country Amina Jindani, Honorary Senior Lecturer, St George's, University of London When are transportation studies required and when not? Is transportation the same as storage? Which products need are at risk and protection Which trade lanes, modes of transport are at risk When do we need to do transportation studies? Nigel Cryer, Head of Quality GMP Readiness, Crucell Medical components which are temperature sensitive especially in the domain (+2, +8 C) Transportation and storage of blood or vaccines. Eric Devin, Development Managing Director, Cemafroid Ensuring Quality of During Cold Storage: Lessons from Biobanking Dealing with labile biological materials Monitoring sample quality throughout storage What biobanking can teach us about cold chain storage and how to apply these lessons learnt Future challenges in the industry John Cason, Director of the KCL Infectious Diseases BioBank, King's College London Chairman s Closing Remarks Networking Lunch Close of Day Two fax your registration to +44 (0) or call +44 (0)

4 SITE VISIT TO THE WORLD COURIER HEATHROW SITE WEDNESDAY 5TH DECEMBER 2012, THE WORLD COURIER HEATHROW SITE, UK World Courier Site Visit, Wednesday 5th December, , World Courier Heathrow Site, UK Site Visit Overview SMi in association with World Courier are giving you a unique opportunity to witness the journey of your product through the operations of a leading courier in a post-conference site visit! This year you will have the opportunity visit one of World Courier s biggest sites, situated at Heathrow Airport. You will observe live operations to get a true understanding of the handling of your product throughout its distribution. Timetable Arrival of delegation at airport coach from the Marriott Regents Park & coffee break Welcome by Sue Lee/Mark Bishop Briefing of the event Q&A Presentation at airport office A full tour of the facility, focussing on: - Packaging - Stock holding - Distribution WC Ground temperature controlled vehicles A demonstration of the vehicles A summary of how they contribute to the distribution of pharmaceuticals The factors that make the vehicles unique Transfer to Hilton T Interactive workshop An opportunity to experience 1st hand the cold chain process An interactive session with two KOL's in the distribution industry Hosted by Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa Q&A Lunch Transfer back to the Marriott Regents Park About the Site Visit Leaders Mark Bishop has been with World Courier since As Sales & Marketing Director, he leads a team of 11 account managers responsible for the UK, Ireland, Middle East and Africa. His previous roles within the World Courier group of companies include, Regional Director Far East based in Hong Kong, and Regional Director Asia Pacific based in Australia and Singapore. Sue Lee has a background in microbiology and has worked for World Courier for over 20 years. In her new role as Regional Quality Manager she is part of a global team working on quality issues, using a Risk Management based approach, and in the development of new and innovative systems for packaging, & temperature control She provides consultation and technical expertise to shippers, sponsors, and labs. She is a qualified DSGA for road and rail and IATA-trained for shipping dangerous goods including radioactives. Sue is also a member of the Institute of Freight Professionals (Grad). WELCOME DRINKS RECEPTION SMi Group invite all workshop and conference delegates, speakers and sponsors to join them for a networking welcome drinks reception at 5.30pm at the Marriott Hotel Regents Park. Meet and network with fellow attendees in a relaxed environment before the conference. New for 2012: Evening Dinner at the Gilgamesh Restaurant SMi Group invites you to join them for a post conference dinner reception following the end of the first day. Dinner will be held at Gilgamesh Restaurant and Bar where you will have the extended opportunity to network with industry professionals. Jump aboard a traditional red london bus at the hotel at 7.00pm for a real London experience. Leave Cold Chain 2012 having forged new working relationships and strengthened your current ones. The Gilgamesh Restaurant and Bar combines history with elements of contempory design and modern art to make one of the most visually stunning venues in central London. In the Babylon Bar you will experience some of the finest pan-asian cuisine prepared by award winning chefs. Dine, drink and socialize in jaw dropping surrounds. A truly unforgettable experience. HOSTED BY New for 2012: SMi Event Communities SMi Group is a global events business specialising in business to business conferences, workshops and masterclasses. We successfully create and run 250 events every year across 6 sectors including Defence and Security, Energy and Utilities, Finance and Pharmaceuticals. We believe in bringing together the most knowledgeable experts from across the globe in each sector to learn, engage, share and network be it in London, Paris or Singapore. To further enhance the SMi experience, we have launched our very own SMi Event Communities. These will be exclusive, private and secure communities in which our clients will learn, share, engage and network. The SMi Event Communities will build and expand your experience beyond the conference, workshop or Masterclass you attend. Not just another "social network, SMi s Event Communities have been specifically designed around the needs of our delegates, speakers and sponsors, allowing all of our clients to foster longer term relationships with all of the other attendees beyond the three day event for year round engagement. To take part all you need to do is register for this event. SMi Group Communities Learn Engage Share Network

5 Cold Chain Distribution 2012 Sponsors Lead Sponsor Sponsors World Courier: As cold chain shipments excursions face increased scrutiny from regulators around the world, it is more important than ever before to get it right the first time. World Courier is the sole truly global premium logistics provider to offer a cold chain transport service. We lend intangible regulatory insight, unmatched experience and value-added support worldwide, including emerging markets such as Brazil, India, Argentina and Russia. Elpro is an innovative provider of solutions for the monitoring of environmental conditions throughout the supply chain of perishable goods. We develop, produce and sell our own hard- and software solutions driven by customer demand, so they are able to monitor and document physical measurements compliance with regulatory requirements. Today's state-of-the-art concepts are LIBERO PDF-Logger and the Central Monitoring System with ECOLOG-NET and elprolog software. Our solutions result in the lowest total cost of ownership for our customers. Sensitech: As the world's leading provider of cold chain visibility solutions, Sensitech enables global leaders in the life sciences, food, and industrial markets to track and monitor assets across the supply chain in order to protect the integrity of temperaturesensitive products. Sensitech 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 Climate, Controls & Security, a unit of United Technologies Corp., a leading provider to the aerospace and building systems industries worldwide. SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company's marketing strategy. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick, SMi Sponsorship on +44 (0) or amalick@smi-online.co.uk Supported by Want to know how to get involved? Interested in promoting your services to this market? Contact Margaret Mugema on +44 (0) or mmugema@smi-online.co.uk

6 FAX your booking form to +44 (0) PHONE on +44 (0) COLD CHAIN DISTRIBUTION 3RD - 4TH DECEMBER 2012 MARRIOTT REGENTS PARK, LONDON, UK 4 WAYS TO REGISTER POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, Harling House, Great Suffolk Street, London, SE1 0BS, UK EARLY BIRD DISCOUNT Book by 28th September 2012 to receive a 100 off the conference price CONFERENCE PRICES Unique Reference Number Our Reference DELEGATE DETAILS LVP-053 Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Company VAT Number: Address: Town/City: Post/Zip Code: Direct Tel: Mobile: Switchboard: Country: Direct Fax: Signature: I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Address (if different from above): Town/City: Post/Zip Code: Direct Tel: Country: Direct Fax: Date: 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 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 quoting the URN as detailed above your address on the attached letter. I would like to attend: (Please tick as appropriate) Fee Total Conference only VAT First 25 Pharmaceutical Companies Conference only LIMITED AVAILABILITY VAT REGISTRATION INCLUDES FREE ATTENDANCE AT (PLEASE TICK) Post-Conference World Courier Site Visit (5th December) End of Day 1 Evening Dinner at Gilgamesh Restaurant and Bar (3rd December) PROMOTIONAL LITERATURE DISTRIBUTION Distribution of your company s promotional literature to all conference attendees VAT GROUP DISCOUNTS AVAILABLE The conference fee includes refreshments, lunch, conference papers and access to the Document Portal containing all of the presentations. 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) , hotels@smi-online.co.uk or fax +44 (0) DOCUMENTATION I cannot attend but would like to purchase access to the following Document Portal/paper copy documentation Price Total Access to the conference documentation on the Document Portal VAT The Conference Presentations paper copy (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-053 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 , Account Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account IBAN GB48 LOYD 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: I agree to be bound by SMi's Terms and Conditions of Booking. Card Billing Address (If different from above): VAT Date: VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on 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) or you can them at events@smi-online.co.uk