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THE 8TH ANNUAL CONFERENCE ON...

COLD CHAIN
DISTRIBUTION
3RD - 4TH DECEMBER 2013 | MARRIOTT HOTEL REGENTS PARK, LONDON, UK...
DAY ONE | 3RD DECEMBER 2013
08.30

Cold Chain Distribution
GLOBAL DISTRIBUTION STRATEGIES

REGISTRATION & COFFEE
EUROPEAN ...
Cold Chain Distribution

DAY TWO | 4TH DECEMBER 2013
08.30

REGISTRATION & COFFEE

09.00

CHAIRMAN’S OPENING REMARKS:
Sue ...
PRE-CONFERENCE WORKSHOP
Monday 2ND December 2013
13.00 – 17.30
Marriott Hotel Regents Park, London, UK

Transport Strategi...
SMi PHARMACEUTICALS
FORWARD PLANNER 2013-2014
SEPTEMBER
Cancer Vaccines
18 – 19 September 2013, London
OCTOBER
Biosimilars...
COLD CHAIN DISTRIBUTION
3RD - 4TH DECEMBER 2013 | MARRIOTT HOTEL REGENTS PARK, LONDON, UK

WORKSHOP: 2ND DECEMBER 2013 | L...
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SMi Group's 8th annual Cold Chain Distribution

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SMi Group's 8th annual Pharmaceutical Cold Chain Distribution conference & exhibition returns in December

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Transcript of "SMi Group's 8th annual Cold Chain Distribution"

  1. 1. THE 8TH ANNUAL CONFERENCE ON... COLD CHAIN DISTRIBUTION 3RD - 4TH DECEMBER 2013 | MARRIOTT HOTEL REGENTS PARK, LONDON, UK BOOK 30TH SEPT BY EMBER SAVE £100 FIRS PHARMA C T 25 OMPANIES ONLY £999 Key speakers include: • The UK's only pharmaceutical cold chain distribution conference returns for its 8th year • Receive vital updates on regulation and GDP guidelines and how they will affect your supply chain • Hear experts discuss important case studies on successful air and sea freighting and temperature control strategies • New topics for 2013 include: Transportation of dangerous goods by air, Risk evaluation of sea freighting, Comparisons of cold chain monitoring devices, Effective collaboration with vendor companies • End of day 1 drinks reception and dinner at Shaka Zulu • Yoram Eshel, Senior Director, Teva • Jason Cameron, Senior Director, European Commercial Supply Chain, Genzyme • Riekert Bruinink, Member of the GDP drafting Group of the EMA, Dutch Health Care Inspectorate • Bev Nicol, Distribution Specialist, Pfizer • Mark Edwards, Global Freight Manager, Actavis • Stephen Mitchell, QA Manager, Quality & Compliance, Logistics, GSK • Alan Dorling, Global Head - Pharmaceuticals & Life Sciences, IAG Cargo • Andrea Gruber, Manager Cargo Business, IATA • Sue Lee, Regional Quality Manager, World Courier PLUS AN INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOP Monday 2nd December 2013 | Marriott Hotel Regents Park, London, UK Transport Strategies for an Intemperate World Hosted by World Courier Workshop Leader: Sue Lee, Regional Quality Manager, World Courier 13.00 - 17.30 Lead Sponsor Sponsored by www.coldchain-distribution.com Register online, call +44 (0) 20 7827 6156 or fax your registration form to +44 (0) 20 7827 6157 @SMIpharm uk.linkedin.com/in/smipharma/ FREE TO ATTEND FOR PHARMA COMPANIES
  2. 2. DAY ONE | 3RD DECEMBER 2013 08.30 Cold Chain Distribution GLOBAL DISTRIBUTION STRATEGIES REGISTRATION & COFFEE EUROPEAN AND INTERNATIONAL REGULATION 09.00 09.10 09.50 CHAIRMAN'S OPENING REMARKS Tony Wright, Managing Director, Exelsius Cold Chain Management KEYNOTE ADDRESS Global temperature-sensitive pharmaceutical logistics: Introduction and overview • How well has our industry managed the challenges so far? • What challenges are on the horizon – how do we prepare for them? • How do we improve quality within the healthcare logistics process? • Is our industry facing 'over-regulation' or just lacking in global harmonization? Tony Wright, Managing Director, Exelsius Cold Chain Management Temperature controlled transport - A risk mitigation approach according to the EU GDP • EU GDP and transport • Risk management • Transport strategies • Qualification and monitoring Luc Huybreghts, Senior Consultant, Pauwels Consulting 14.00 14. 40 Transporting dangerous goods by air • Global overview of the dangerous goods regulations for air transport • Responsibilities of the shipper • Coolants (Dry Ice, Liquid Nitrogen, etc…) • Battery-powered data logging devices Brendan Sullivan, Manager, Dangerous Goods and Training Standards, IATA Recommendations concerning transportation of +2°C +8°C medicinal products • Regulation update since 2012 for the cold chain • Recommendations 1 of French Pharmacist Council : Qualification and measure of temperatures for trucks • Recommendations 2 of French Pharmacist Council : Maintenance of trucks • Recommendations 3 of French Pharmacist Council : Limits of responsibility Marie Boned, Quality Assurance, Cemafroid AFTERNOON TEA 15.40 IATA Standards: Air freight transportation of temperature sensitive products • Transforming the air cargo supply chain • What are the challenges faced by the industry when transporting temperature controlled products? • How are the challenges addressed by IATA in a supply chain collaborative approach? • The way forward and future requirements Andrea Gruber, Manager Business Process & Standards, IATA 16.20 Sea Freight – An evaluation of the opportunities and risks with moving pharma shipments by sea instead of air • Process differences between the two modes. • Quality differences between the two modes. • Cost differentials. • Advantages and disadvantages of each mode Mark Edwards, Global Freight Manager, Actavis 17.00 Panel Discussion: The impact of the revised EU GDP on the management of temperature sensitive products in the supply chain • Chair: Tony Wright, Managing Director, Exelsius Cold Chain Management • Stephen Mitchell, QA Manager, Quality & Compliance, Logistics, GSK • Luc Huybreghts, Senior Consultant, Pauwels Consulting • Yoram Eshel, Senior Director, Teva 17.40 Chairman’s closing remarks and close of day one 18.00 Drinks reception followed by Dinner at Shaka Zulu. Transfer to hotel MORNING COFFEE 10.50 15.20 21.30 10.30 11.30 12.10 12.50 Chemistry-based track and trace indicators • 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, University of Leeds An integrated view on Supply Chain Management • What does Supply Chain Management (SCM) really mean? • The role of SCM in Cool Chain Management? • Demand management a first step to more reliable planning. • Supply and demand balancing in your network. • Important Supply Chain KPI´s. Rüdiger Lohmann, Professor, Researcher, Lübeck University of Applied Science NETWORKING LUNCH KEYNOTE ADDRESS Temperature control management in the supply chain • CRT Vs. Ambient – do they really define the required temperature regime? • The current paradigms about controlled temperature logistics. • How CRT shipments look like in real life? • How to practically manage your controlled temperature transportation – the new language we have to speak. Yoram Eshel, Senior Director, Teva Register online at: www.coldchain-distribution.com • Alternatively fa Lead Sponsor Incorporated in 1969, World Courier is the leader in specialty logistics for global clinical trials delivering fully-integrated GxP-compliant temperaturecontrolled 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. worldcourier.com Sponsored by ELPRO, founded in 1986, is a leading Swiss manufacturer of innovative solutions for monitoring environmental conditions throughout the perishable goods supply chain. The monitoring process consists of measuring, recording and managing data. Then, based on the stability criteria, the data is assessed for release or alarm. Our solutions result in the lowest total cost of ownership for our customers while ensuring compliance and maximum efficiency. We partner with our clients to develop solutions that integrate our high-quality measurement components into their business processes. The main industries we serve are in the pharmaceutical and healthcare sectors, but our products are also used in many other fields, such as the environmental management, bio-banking & life sciences and the food industries. We provide solutions for laboratory, production, storage and transportation through to the end user. Through our subsidiaries and a network of trained distributors ELPRO is active worldwide. www.elpro.com Kuehne + Nagel is a world leader in providing integrated logistics services for the pharmaceutical and healthcare industries. We work with some of the world's leading companies, and with other clients in related industries like medical equipment, animal drugs, personal care, and infant formula categories. www.kuehne-nagel.com Temperature Sensitive Solutions (TSS) offers Temperature Data loggers and a cutting edge Temperature Monitoring System (CCIS) that meets the need for full visibility in order to improve shipments processes and lower costs. TSS and its key global customers have together taken the important step to break old patterns and solve tomorrow’s challenges. CCIS provides outstanding added value by processing captured shipping data and translate it into core business information. www.tss.se
  3. 3. Cold Chain Distribution DAY TWO | 4TH DECEMBER 2013 08.30 REGISTRATION & COFFEE 09.00 CHAIRMAN’S OPENING REMARKS: Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier TEMPERATURE CONTROL MANAGEMENT AND SUPPLY CHAIN INTEGRITY 13.20 The global standard for supply chain resilience • Introduction to TAPA Cargo Security Standards • Case study of Truck Security Requirements • Incident Information Service • Training Programmes for TAPA members Jason Breakwell, Director, TAPA EMEA 14.00 Challenges in air freighting of time and temperature sensitive freight • Identifying and managing key risk points at the airport • Quality & Compliance across a global network • The need for supply chain collaboration - taking a tripartite approach • Maximising service performance Alan Dorling, Global Head - Pharmaceuticals & Life Sciences, IAG Cargo 14.40 AFTERNOON TEA 15.00 Challenges of cold chain distribution within the pharmaceutical industry • How cold chain products are managed • Utilisation of Validated shipping solutions • Benefits and Constraints • Working with Vendors for maximum effectiveness Bev Nicol, Distribution Specialist, Pfizer Christina Hilsden, Distribution Specialist, Pfizer Sea Freight – +2C to +8C temperature control for biologics • Advantages and Disadvantages of Sea Freight • Sea Freight Container Study Approach • Sea Freight Container Study - +2C to +8C Temperature Monitoring • Sea Freight Temperature Data Analysis Janusz Mielewczyk, Cold Chain Validation Specialist, Pfizer TEMPERATURE CONTROL MANAGEMENT AND TECHNOLOGY 09.10 09.50 Temperature Issues within the context of clinical trials logistics. Practical examples and solutions • What are the common challenges facing shippers • How temperature requirements can drive logistics options • What can be done by shippers and 3PLs to improve the process and to ensure operational conformity and optimum results Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier KEYNOTE ADDRESS New EU Good Distribution regulations • The New EU GDP Guide in general • What is new? Where more guidance ? • Outlining the new items for temperature control during storage and transportation • Implementation issues Riekert Bruinink, Member of GDP drafting Group, Dutch Health Care Inspectorate 10.30 MORNING COFFEE 10.50 Creating efficiency by integrating stability data into your monitoring solution • What is stability data? • Why is cold chain expensive? • Technology to work with stability data • Examples on how to use stability data • Concerns about using stability data & solutions Martin Peter, Head of Sales & Marketing, ELPRO-BUCHS AG 15.40 11.30 A practical approach to managing the temperature-sensitive supply chain • Why temperature sensitive-supply chains fail a GDP audit • Common reasons for non-conformance • Understanding packaging, temperature measurement and transport • Taking a proactive approach to getting it right Bob Hayes, Director, Cold Chain Consultants 16.20 12.10 NETWORKING LUNCH 17.00 KEYNOTE ADDRESS Improving last mile distribution strategies • Evaluating the physical distribution strategies • How this affects the last mile • Developing and implementing effective methods • Impacts on patients and future distribution Jason Cameron, Senior Director, European Commercial Supply Chain, Genzyme Chairman’s closing remarks and close of day two ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 Who should attend this conference? This event is unnmissable for... • Global Category Manager • Logistics Manager CEE & Asia • Operations Director • Logistics Manager • QA Manager • Supply Chain Supervisor • Cold Chain Specialist • Cold Chain & Shipping Validation Specialist • Principle Supply Chain Analyst • Clinical Supply Technician • Logistics manager • Consultant - Supply Chain • And others... New for 2013 Evening Dinner Day 1 at Shaka Zulu There will be an Evening Dinner at the end of day 1 taking place at London's illustrious Shaka Zulu restaurant. Transfer will be from and to the hotel after the drinks reception. Places are subject to availability. www.shaka-zulu.com Supported by
  4. 4. PRE-CONFERENCE WORKSHOP Monday 2ND December 2013 13.00 – 17.30 Marriott Hotel Regents Park, London, UK Transport Strategies for an Intemperate World Workshop Leader: Sue Lee, Regional Quality Manager, World Courier FREE TO ATTEND for Pharma companies. Overview: Never have Clinical Trial Logistics been more challenging than today. Consignors face shipping into emerging markets with stricter temperatures ranges, increasing regulatory requirements, budgetary restraints and shrunken timescales and supplies. Getting drugs to market quickly and successfully is what matters, wading through these supply chain complexities, temperature challenges into hostile environments, whilst keeping stakeholders informed and satisfied can feel like juggling elephants on a daily basis. Aim: This workshop will address common problems and practical issues, identifying key factors, offering realistic advice and sources of information. Delegates will get out of the workshop a clear awareness of problems and solutions, operational regulatory and quality solutions as well as a greater understanding of critical industry issues. Programme: 13.00 Registration and Coffee 13.30 Welcome and Introductions 13.40 Emerging Markets, what are the issues • Considering multiple locations to establish what challenges we all face 14.30 Regulatory Challenges • What agencies matter and how do you keep up to date? • Understanding how the regulations affect shipment • Avoiding some common mistakes 15.15 Afternoon Tea 15.45 Packaging & Temperature control • Passive or active? • Single use or reusable, is it cost effective and compliant to be green? • A practical challenge 17.00 Discussion 17.30 End of Workshop About the host: Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier Sue trained in Microbiology, but then left hands on science to pursue an alternate career in logistics. She has worked for World Courier for more than 20 years. As the Regional Quality Co-ordinator for UK, Eire, Middle East and Africa, she is part of a global team working on development of new and innovative quality systems and ensuring compliance of offices and suppliers. She acknowledges that few other people appreciate the joy and satisfaction she has in creating user friendly work flow instructions and SOPs, with lovingly hand crafted prose.
  5. 5. SMi PHARMACEUTICALS FORWARD PLANNER 2013-2014 SEPTEMBER Cancer Vaccines 18 – 19 September 2013, London OCTOBER Biosimilars & Biobetters 1 – 2 October 2013, London Diabetes 1 – 2 October 2013, London Orphan Drugs 14 – 15 October 2013, London COPD: Novel Therapeutics and Management Strategies 16 – 17 October 2013, London European Pharmaceutical Pricing & Reimbursement 21 – 22 October 2013, London Point of Care Diagnostics - Market Opportunities and Technology Trents 23 – 24 October 2013, London NOVEMBER Cell Based Assays 18 – 19 November 2013, London Clinical Trials in CNS 18 – 19 November 2013, London DECEMBER Cold Chain Distribution 3 – 4 December 2013, London JANUARY Pharmaceutical Microbiology 20 – 21 January 2014, London Social Media in the Pharmaceutical Industry 22 – 23 January 2014, London Quality By Design 22 – 23 January 2014, London Pre-Filled Syringes 27 – 28 January 2014, London FEBRUARY Parallel Trade 10 – 11 February 2014, London Advances and Progress in Drug Design 17 – 18 February 2014, London MARCH Superbugs and Superdrugs - A Focus on Antibacterials 5 – 6 March 2014, London Imaging in Cancer Drug Development 12 – 13 March 2014, London Controlled Release 12 – 13 March 2014, London Paediatric Clinical Trials 24 – 25 March 2014, London Adaptive Designs 24 – 25 March 2014, London 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 on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
  6. 6. COLD CHAIN DISTRIBUTION 3RD - 4TH DECEMBER 2013 | MARRIOTT HOTEL REGENTS PARK, LONDON, UK WORKSHOP: 2ND DECEMBER 2013 | LONDON, UK 4 WAYS TO REGISTER ONLINE at www.coldchain-distribution.com POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, FAX your booking form to +44 (0) 20 7827 6157 Harling House, 47-51 Great Suffolk Street, London, SE1 0BS PHONE on +44 (0) 20 7827 6156 EARLY BIRD DISCOUNT □ Book by 30th September and save £100 off conference price CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee Commercial Organisations □ Conference only £1499.00 +VAT First 25 Pharma Companies □ Conference LIMITED AVAILABILITY £999.00 +VAT REGISTRATION INCLUDES FREE ATTENDANCE AT (PLEASE TICK) □ Pre-Conference workshop hosted by World Courier □ End of day 1 Evening Dinner at Shaka Zulu restaurant (For pharmaceutical companies only) Unique Reference Number Our Reference LV P-089 DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 Total £1798.80 £1198.80 +VAT £1198.80 The conference fee includes refreshments, lunch, conference papers and access to the Document Portal containing all of the presentations. Job Title: Department/Division: VENUE Company/Organisation: Marriott Hotel Regents Park, 128 King Henry's Road, London, NW3 3ST Email: □ Please contact me to book my hotel Address: Alternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712 Town/City: Post/Zip Code: DOCUMENTATION Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: 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 £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 £499.00 (or only £300 if ordered with the Document Portal) I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT Title: PAYMENT Forename: Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-089 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: Surname: Email: Address (if different from above): □ UK BACS □ Wire Transfer Town/City: Post/Zip Code: Direct Tel: Country: Direct Fax: 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. □ Cheque □ Credit Card Sort Code 300009, Account 00936418 Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18 We can only accept Sterling cheques drawn on a UK bank. □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Card No: 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): 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.smionline.co.uk/updates quoting the URN as detailed above your address on the attached letter. VAT 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) 870 9090 711 or you can email them at events@smi-online.co.uk

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