2nd - 3rd Cold Chain Distribution CHAIRS FOR 2014: BUSINESS BENEFITS FOR 2014: a TCP Company.

Transcription

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 Cold Chain Distribution DEC Enhance Temperature Management for an Efficient Supply Chain 2014 Marriott Regents Park Hotel, London, UK NEW BROCHURE RELEASED! CHAIRS FOR 2014: Alan Dorling, Global Head - Pharmaceutical & Life Sciences, IAG Cargo Andrea Gruber, Senior Manager, Specialised Cargo, IATA Tony Wright, Managing Director, Exelsius Cold Chain Management Lead Sponsor: Sponsored by: 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 BUSINESS BENEFITS FOR 2014: a TCP Company 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 Current attendees include: AAH Pharmaceuticals Allergan Alliance Healthcare Bosch Connected Devices & Solutions Eli Lilly F. Hoffmann-La Roche Ltd GSK Mundipharma Priority Freight LHR Ltd Public Health England Roche Pharmaceuticals Sanofi-Aventis Takeda Pharma International The Saudi FDA The Blood Transfusion Centre of Slovenia plus many more BOOK BY 31ST OCTOBER TO RECEIVE 100 OFF Register online or fax your registration to +44 (0) or call +44 (0)

2 Cold Chain Distribution Day One Tuesday 2nd December Registration & Coffee ENHANCING SUPPLY CHAIN EFFICIENCIES 9.00 Introductory Icebreaker 9.05 Chair's Opening Remarks Tony Wright, Managing Director, Exelsius Cold Chain Management REGULATORY UPDATES AND IMPLEMENTATION PART ONE OPENING ADDRESS The wholesale distribution of medicinal products is an important activity in integrated supply chain management. Today s distribution networks are increasingly complex and involve many players. Implication of the changes of Legislation / Guidance Holding and storing medicinal product who will require a WDA(H) Transportation under controlled conditions The inspection regime and achieving compliance expectations of the regulator Cheryl Blake, GDP Inspector, MHRA KEYNOTE ADDRESS 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 2.40 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 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 temperaturecontrolled supply chain solutions according to the latest WHO and EU GDP guidelines Daniel Liebermann, Director, Directorate Logistics, Ministry of Economy, Luxembourg 3.20 Afternoon Tea Morning Coffee 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 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 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 4.30 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 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 5.10 Chairman's Closing Remarks and Close of Day One 7.30 Dinner at Gordon Ramsay s Maze Restaurant sponsored by: Networking Lunch Want to know how you can get involved? Interested in promoting your services to this market? Contact Julia Rotar, SMi Marketing on +44 (0) or 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: Alternatively fa

3 Day Two Wednesday 3rd December Registration & Coffee 9.00 Chair's Opening Remarks Andrea Gruber, Senior Manager, Special Cargo, IATA TEMPERATURE MANAGEMENT AND MONITORING Networking Lunch 1.20 Chair s Afternoon Opening Remarks Alan Dorling, Global Head - Pharmaceutical & Life Sciences, IAG Cargo 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 GDP IMPLEMENTATION AND RISK MITIGATION 1.30 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 PART TWO 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 Morning Coffee Vehicle Temperature Compliance Solutions Challenges we face due to vehicle and country climatic differences. Results from independently controlled testing. Options and recommendations for whole vehicle temperature control. Active temperature control for low temperature regulation (+2 to +8 degrees centigrade) using portable solutions. Vince Lee, Managing Director, Eberspächer UK Ltd ROUND TABLE DISCUSSION 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 ROUND TABLE DISCUSSION 2.10 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 2.50 Afternoon Tea KEYNOTE ADDRESS 3.20 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 4.00 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 4.40 Chair's Closing Remarks Platinum Media Partner Supported by Silver Media Partner x your registration to +44 (0) or call +44 (0)

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 GxPcompliant temperature-controlled transport, storage and distribution solutions worldwide in over 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. 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 by Industry Sector REGULATORY 9% SERVICES/PRODUCT SUPPLIERS 33% ACADEMIA 7% PHARMACEUTICAL 51% Cold Chain Distribution Attendees by Region MIDDLE EAST 6% USA 4% UK AND EUROPE 90% DISTRIBUTION GDP COMPLIANCE TEMPERATURE MANAGEMENT SUPPLY CHAIN EFFICIENCY

5 Cold Chain Distribution Tuesday 2nd and Wednesday 3rd December 2014 Sponsors/Exhibitors: 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. 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. a TCP Company 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. Eberspächer UK Eberspächer UK, a wholly owned subsidiary of Eberspaecher Climate Control Systems GMBH & Co KG. is the market leader in the supply of independent heaters, air conditioning and climate control solutions for all vehicle transport applications. Climate systems combine an independent heater and an air conditioning system to provide fully automatic temperature control in the vehicle ideally suited for GDP compliance applications. In addition Eberspächer distribute a wide range of portable refrigerated and heated insulated containers used throughout Europe for the transport of temperature sensitive drugs, vaccines and bio-medical products 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. FedEx Corporation FedEx Corporation provides customers and businesses worldwide with a broad portfolio of transportation, e-commerce and business services. With annual revenues of $45 billion, the company offers integrated business applications through operating companies competing collectively and managed collaboratively, under the respected FedEx brand. Consistently ranked among the world's most admired and trusted employers, FedEx inspires its more than 300,000 team members to remain "absolutely, positively" focused on safety, the highest ethical and professional standards and the needs of their customers and communities. Kingspan Protective Packaging (KPP) Kingspan Protective Packaging (KPP), part of the 1.8bn Kingspan Group, specialises in custom moulded & pre-cut protective packaging that is perfect for cold chain transportation. Expanded polystyrene (EPS) demonstrates excellent thermal properties and, in conjunction with Kingspan s Optim-R (Vacuum Insulated Panels), provides the ideal lightweight, recyclable, impactresistant cold chain packaging solution. 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. 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. 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. 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. 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 or amalick@smi-online.co.uk

6 COLD CHAIN DISTRIBUTION 2ND - 3RD DECEMBER 2014 MARRIOTT REGENTS PARK, LONDON, UK FAX your booking form to +44 (0) PHONE on +44 (0) WAYS TO REGISTER WORKSHOP: MONDAY 1ST DECEMBER 2014, LONDON 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 31st October 2014 to receive 100 off the conference price Unique Reference Number Our Reference DELEGATE DETAILS LVP-124 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: Date: 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: 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) 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. 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CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee Total Conference only VAT REGISTRATION INCLUDES FREE ATTENDANCE AT (PLEASE TICK) End of Day Evening Dinner at Gordon Ramsay's Maze Restaurant (2nd December) (subject to availability, only 5 places available for Pharma only) PROMOTIONAL LITERATURE DISTRIBUTION Distribution of your company s promotional literature to all conference attendees VAT 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 address provided during registration. Details are sent within 24 hours post conference. 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