SMi Group's Pharmaceutical Cold Chain Distribution conference & exhibition

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@SMIPHARM 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 Current attendees include: • AAH Pharmaceuticals • Allergan • Alliance Healthcare • Eli Lilly • F. Hoffmann-La Roche Ltd • 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… CHAIRS FOR 2014: 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 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: 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 SMi Presents the 9th Annual Conference on… 2nd - 3rd DEC 2014 Marriott Regents Park Hotel, London, UK Cold Chain Distribution Enhance Temperature Management for an Efficient Supply Chain Lead Sponsor: Sponsored by: “In general, a very well organised event. Professional team and well executed” EVENT ATTENDEE 2013 a TCP Company

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SMi Group's 9th annual Cold Chain Distribution event is back this December, promising to be the biggest in many years

Transcript of SMi Group's Pharmaceutical Cold Chain Distribution conference & exhibition

Page 1: SMi Group's Pharmaceutical Cold Chain Distribution conference & exhibition

@SMIPHARM

www.coldchain-distribution.com BOOK BY 30TH SEPTEMBER 2014 TO RECEIVE £300 OFF

BOOK BY 31ST OCTOBER TO RECEIVE £100 OFFRegister online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

Current attendees include: • AAH Pharmaceuticals• Allergan• Alliance Healthcare• Eli Lilly

• F. Hoffmann-La Roche Ltd• 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…

CHAIRS FOR 2014: Cheryl Blake, GDP Inspector, MHRA

Alan Dorling, Global Head - Pharmaceutical & LifeSciences, IAG Cargo

Andrea Gruber, Senior Manager, Specialised Cargo,IATA

Tony Wright, Managing Director, Exelsius Cold ChainManagement

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:Benchmark and reflect on the implementation of the GDPdirective with case studies from IATA, AbbVie and the DutchHealth Care Inspectorate

Enhance your understanding of the challenges of transportqualification for temperature sensitive pharmaceuticalproducts with a round table discussion led by Tony Wright,Managing Director, Exelsius Cold Chain Management andan opening address from Alan Dorling, Global Head -Pharmaceutical & Life Sciences, IAG Cargo

Strengthen your supply chain through management andefficiency insights from Merck Serono and Genzyme

SMi Presents the 9th Annual Conference on… 2nd - 3rd

DEC2014

Marriott Regents Park Hotel, London, UK

Cold Chain DistributionEnhance Temperature Management foran Efficient Supply Chain

Lead Sponsor:

Sponsored by:

“In general, a very well organised event. Professional team and well executed” EVENT ATTENDEE 2013

a TCP Company

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Register online at: www.coldchain-distribution.com • Alternatively fa

Cold Chain Distribution Day One | Tuesday 2nd December 2014

8.30 Registration & Coffee

9.00 Introductory Icebreaker

9.05 Chair's Opening RemarksTony Wright, Managing Director, Exelsius Cold ChainManagement

REGULATORY UPDATES AND IMPLEMENTATION

OPENING ADDRESS9.10 GDP compliance – A UK regulatory perspective

•Ensuring qualification and validation over the life cycle of theproduct and process

•Enhancing a quality risk management approach throughout the lifecycle of a medicinal product

•Taking steps towards ensuring standardisation andharmonisation 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 DISCUSSIONTransport 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 processLeader: Tony Wright, CEO, Exelsius Cold Chain Management

1.00 Networking Lunch

ENHANCING SUPPLY CHAIN EFFICIENCIES

KEYNOTE ADDRESS2.10 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 andhealthcare 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 novelinnovations 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 marketsDavid Spillett, Business Development Manager, BiopharmServices, World Courier

4.40 The Implementation of the new GDP guidelines using real lifeexperiences 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 yourservices to this market?

Contact Julia Rotar, SMi Marketing

on +44 (0) 207 827 6088 or email: [email protected]

PARTONE

World Courier will be hosting a unique and excitingevening dinner at the end of Day 1. This event willbe hosted at Gordon Ramsay’s Maze Restaurantand the Routemaster will pick up from the MarriottRegents Park at 7.30pm. It promises to a fantasticexperience. Places are strictly limited, visit ourwebsite for further details.

Tuesday 2nd DecemberEvening Dinner

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Supported by

ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

Day Two | Wednesday 3rd December 2014

8.30 Registration & Coffee

9.00 Chair's Opening RemarksAndrea Gruber, Senior Manager, Special Cargo, IATA

TEMPERATURE MANAGEMENT AND MONITORING

OPENING ADDRESS9.10 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

collaborationAlan Dorling, Global Head- Pharmaceutical & Life Sciences, IAG Cargo

9.50 A portfolio matrix approach to Temperature ControlPackaging - 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

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

Platinum Media Partner

PARTTWO

Silver Media Partner

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Who shouldattend thisconference:

You should attend this event if you work in the PharmaceuticalIndustry with responsibilities inQuality Assurance, QualityCompliance, Regulatory, SupplyChain, 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 Attendees2011-2013 by Industry Sector

PHARMACEUTICAL51%

REGULATORY 9%

SERVICES/PRODUCTSUPPLIERS 33%

ACADEMIA 7%

Cold Chain Distribution Attendees2011-2013 by Region

UK AND EUROPE 90%

USA 4%MIDDLE EAST 6%

• DISTRIBUTION • GDP COMPLIANCE • TEMPERATURE MANAGEMENT • SUPPLY CHAIN EFFICIENCY •

Cold Chain Distribution Tuesday 2nd and Wednesday 3rd December 2014

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. WorldCourier has a network of over 150 company offices operating in more than 50 countries plus a network of 13 x GMP compliantstorage depots in strategic locations.

Through its company-owned network of offices World Courier provides door-to-door, customs-cleared service to more than 220countries 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 totemperature control is critical for compliance with international regulatory, manufacturing and safety standards. With ourproven track record in Cold Chain Management, World Courier is the only specialty logistics provider that offers comprehensiveand customized temperature-controlled transportation services 24/7/365 worldwide.

www.worldcourier.com

Lead Sponsor:

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AmSafe BridportGlobally renowned, AmSafe Bridport supports air cargo logistics around the world with its industry-tested range ofDuPont™ 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 forthe 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 datamanagement & central monitoring solution “smartview“, you can optimize your workflow and automate processsteps. All our systems are WHO/UNICEF approved. www.berlinger.ch

CryopakCryopak designs and manufactures complete cold chain packaging solutions from fabricating insulated boxes orcool refrigerants to manufacturing phase change materials and temperature monitors. From needs assessment topackage qualification, Cryopak handles your packaging projects with one paramount goal : bringing you ourexpertise to maintain the integrity of your products. www.cryopak.eu

ELPRO Company ProfileELPRO, founded in 1986, is a globally active provider of solutions for monitoring environmental conditions throughoutthe supply chain of perishable goods. While the focus is on pharmaceutical, healthcare, biobanking & life-scienceindustry, ELPRO serves a wide range of industries. Whenever temperature, humidity, pressure, or any otherenvironmental condition is key to the quality of products during production, storage or transport: ELPRO cares forefficiency and compliance. Monitoring means to measure, record, and manage data and – based upon stabilitycriteria – assess the data for release or alarm. www.elpro.com

The Movianto GroupThe Movianto Group is the preferred European supply chain partner for the healthcare industry, with its network ofwholly owned subsidiaries in 11 countries. Our services include: warehousing, transport solutions, repackaging andrelabeling services, controlled drugs, clinical trials and samples management. www.movianto.com

TestoTesto instruments are the solution for every application, whether it is in laboratories, cleanrooms, storage, transport orthe health sector. Testo will be showcasing their range of Data Loggers, including the brand new Testo 184 Logger andSaveris 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—globalleaders in the food, life sciences and industrial markets—to track, monitor and protect the quality and integrity of theirtemperature-sensitive products across complex supply chains. Through its logistics security division, FreightWatchInternational, Sensitech also offers origin-to-destination services that provide customers with real-time cargotransparency, helping them to mitigate such risks as theft, diversion, counterfeiting, and chain of custody. SensitechInc. is an ISO 9001:2008 company based in Beverly, Mass., with more than 30 sales, service and distribution locationsaround the world. Sensitech is a part of UTC Building & Industrial Systems, a unit of United Technologies Corp., a leadingprovider to the aerospace and building systems industries worldwide. www.sensitech.com

Peli Cool LogisticsPeli Cool Logistics specialises in the supply, design, test and qualification of temperature controlled packaging solutionsand is dedicated to meeting the complex needs of the global Healthcare Industry. Customers benefit from theirextensive expertise in ensuring that temperature stability is maintained throughout the distribution chain. Diverseindustry 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 highperforming re-usable CREDOTM shipping systems, single use SHERPA™ and recently released CHRONOSTM Advancehigh 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 topallet accepting shippers. www.cool-logistics.com

Sponsors/Exhibitors:

Cold Chain Distribution Tuesday 2nd and Wednesday 3rd December 2014

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi 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 specificto 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: [email protected]

a TCP Company

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COLD CHAIN DISTRIBUTION 2ND - 3RD DECEMBER 2014 | MARRIOTT REGENTS PARK, LONDON, UK WORKSHOP: MONDAY 1ST DECEMBER 2014, LONDON

4 WAYS TO REGISTER

FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711

www.coldchain-distribution.com POST your booking form to: Events Team, SMi Group Ltd, 2nd FloorSouth, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email [email protected]

Payment: If payment is not made at the time of booking, then an invoice will be issued and must bepaid immediately and prior to the start of the event. If payment has not been received then creditcard details will be requested and payment taken before entry to the event. Bookings within 7 daysof event require payment on booking. Access to the Document Portal will not be given until paymenthas been received.Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, anotherdelegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘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 asubstitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providingthat 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 theconferences documentation via the Document Portal to any delegate who has paid but is unableto attend for any reason. Due to the interactive nature of the Briefings we are not normally able toprovide documentation in these circumstances. We cannot accept cancellations of orders placedfor Documentation or the Document Portal as these are reproduced specifically to order. If we haveto cancel the event for any reason, then we will make a full refund immediately, but disclaim anyfurther 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 ProtectionAct 1998 and we may use this to contact you by telephone, fax, post or email to tell you about otherproducts and services. Unless you tick here □ we may also share your data with third parties offeringcomplementary products or services. If you have any queries or want to update any of the data thatwe hold then please contact our Database Manager [email protected] or visitour website www.smi-online.co.uk/updates quoting the URN as detailed above your address on theattached letter.

Unique Reference Number

Our Reference LVP-124

Terms and Conditions of Booking

DELEGATE DETAILSPlease complete fully and clearly in capital letters. Please photocopy for additional delegates.

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VENUE Marriott Hotel Regents Park, 128 King Henry's Road, London, NW3 3ST

□ Please contact me to book my hotelAlternatively call us on +44 (0) 870 9090 711, email: [email protected] or fax +44 (0) 870 9090 712

□ Book by 30th September 2014 to receive £300 off the conference price

□ Book by 31st October 2014 to receive £100 off the conference priceEARLY BIRDDISCOUNT

Payment must be made to SMi Group Ltd, and received before the event, by one ofthe following methods quoting reference P-124 and the delegate’s name. Bookingsmade within 7 days of the event require payment on booking, methods of paymentare 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

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LIVE STREAMING/ON DEMAND/ DOCUMENTATIONUnable 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

VATVAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on liveStreaming, on Demand, Document portal and literature distribution for all UK customers andfor those EU Customers not supplying a registration number for their own country here.______________________________________________________________________________________________

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 theDocument Portal. Presentations that are available for download will be subject todistribution rights by speakers. Please note that some presentations may not be availablefor download. Access information for the document portal will be sent to the e-mailaddress provided during registration. Details are sent within 24 hours post conference.