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REGISTER BY 30TH SEPTEMBER 2011 AND RECEIVE A £100 DISCOUNT

                          EUROPE’S LEADING COLD CHAIN CONFERENCE

                              SMi present their 6th annual conference on…

           Cold Chain Distribution
                      & New For 2011: Temperature Control Management
                                        Monday 5th & Tuesday 6th December 2011
                                            Marriott Regents Park, London
                                                        KEY SPEAKERS SO FAR INCLUDE:
                                                        Ray Goff                     Nigel Cryer
                                                        Director                                           Head Quality Operations
                                                        Pfizer                                             Arrow Pharrm
                                                        Marc Mostinckx                                     Gerald Cavalier
                                                        Senior Director, Global Logistics Lead             Executive Director
                                                        UCB                                                Cemafroid
                                                        Elvia Quiroz Loriega                               Andrea Graf-Gruber
                                                        Cold Chain & Shipping Validation Specialist        Manager, Cargo Business Process and
                                                        Pfizer                                             Standards
                                                                                                           International Air Transport Association
                                                        Stephen Mitchell
                                                        QA Manager, Quality & Compliance,                  Sue Lee
                                                        Logistics                                          Regional Quality Manager, UK & Ireland
                                                        GSK                                                World Courier

                                                        WHY ATTEND THIS EVENT:
                                                        • Analyse the environmental impact and responsibilities within the cold chain. Reusable
                                                          and recyclable packaging will play an ever more important role to maintain green
                                                          credentials, but are they cost effective?
                                                        • Develop your understanding of data management within your cold chain
                                                        • Understand new regulations - learn how to adapt to new CRT regulations. Gain
                                                          advantage and avoid costly & time consuming auditing
                                                        • Explore the possibility of an uninterrupted cold chain - with supply delays causing massive
                                                          disruption as well as coming at a heavy cost it is more important than ever to effectively
                                                          contingency plan. Minimising and avoiding delay is critical within the cold chain
                                                        • Improve your monitoring of wholesaler security. Passing trust and liability on comes
                                                          with risk but also reward for both parties. Effective management of the relationship is
                                                          therefore critical
                                                        • Evolve your understanding of temperature control management. New temperature
                                                          management regulations effect not just the cold chain, but also room temperature
                                                          storage, as 'room temperature' can fluctuate wildly and needs to be controlled and
                                                          supervised correctly


                      PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
                                    Wednesday 7th December 2011, London Marriott Hotel Regents Park

  Workshop A: Practical Management of Risk                               Workshop B: A Measured Approach Towards
      in the Pharmaceutical Cold Chain                                      Temperature Controlled Shipments
                         Workshop Leader:                                   Workshop leader: Jane Seeley, Managing Director, GeoStasis Ltd
      Robert J Hayes, Director, Cold Chain Consultants (UK) Ltd                                  1.30pm - 5.30pm
                         8.30am - 12.30pm


    Gold Sponsor                                                                           Sponsored by




www.coldchain-distribution.com
Register online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
Cold Chain Distribution
Day One | Monday 5th December 2011                                                                                          www.coldchain-d
8.30    Registration and Coffee                                                                             Cold Chain Planning

9.00    Chairman's opening remarks                                              2.10   Putting a global organization in place to deal with Distribution, Cold
        Sue Lee, Regional Quality Manager, UK & Ireland, World Courier                 Chain Management and Shipping Qualification for new products
                                                                                       • Understanding the key considerations when creating a fit-for-
9.10    Offsetting fuel costs in clinical distribution                                   purpose logistics department
        • Outline of current systems used                                              • Identifying, training and organizing an effective global logistics team
        • 7-8 new ways to offset fuel price increases                                  • Assuring optimal management of shipping solution validation
        • Modelling your response to price increases                                   • Exploring the UCB cold-chain logistical setup and lessons learned in
        Ray Goff, Director Vaccine Research, Pfizer                                      the management of a global cold-chain system
                                                                                       • Examining the methods, procedures and solutions used in the
9.50    When to and why use a specialist courier?                                        transportation of temperature sensitive shipments and the
                                                                                         rationale of the choices made
        A conversation between Finance and Quality to make the best
                                                                                       Marc Mostinckx, Senior Director, Global Logistics Lead, UCB
        decisions about using a clinical trials transport budget
        This will consider what to take into account for:                       2.50   Data Management in Cold Chain
        • Difficult and Emerging Markets                                               • Why is it important to collect and manage the temperature data
        • Temperature Controlled Shipments                                               coming from cold chain monitoring?
        • Controlled Drugs                                                             • What are the challenges with data management in Cold Chain?
        • Biologics and Biomarkers                                                     • What are the solution approaches and what are the advantages and
        Sue Lee, Regional Quality Manager, UK & Ireland, World Courier                   disadvantages of the different approaches?
                                                                                       • "Big Pharma best practice example": Monitoring and data
10.30   Morning Coffee                                                                   management process in a complex supply chain
                                                                                       Martin Peter, Director, Elpro-Buchs AG
                         Temperature Control Analysis
                                                                                3.30   Afternoon Tea
11.00   Pharmaceuticals cold chain guidelines update
        • International transport under controlled temperature for              4.00   Panel Discussion: Emerging regulatory temperature monitoring
          pharmaceuticals                                                              requirements for non cold chain products
        • Last km of pharmaceuticals cold chain                                        • Discussion on regulatory expectations
        • Certification initiatives and frames for pharmaceuticals cold chain            - Which regulators are active in this area?
        • Sustainability of pharmaceuticals cold chain                                   - What is in / out of scope?
                                                                                       • Approaches to managing the requirements
        Gérald Cavalier, Executive Director, Cemafroid
                                                                                       • What to do with data that has not been collected before & dealing
                                                                                         with ‘excursions’
11.40   Predictive risk-based supply modelling in clinical trials
                                                                                       Panel Chair: Stephen Mitchell, QA Manager, Quality & Compliance,
        • Main uncertainties and risks in CT supply chain process
                                                                                       Logistics, GlaxoSmithKline
        • Predictive patient recruitment modelling tool
        • Risk-based supply predictive modelling                                5.00   Chairman's Closing Remarks
        • Software tools for supply modelling
        Prof. Dr. Vladimir Anisimov, Senior Director, Quantitative Sciences,    5.10   Drinks Reception
        GlaxoSmithKline - UK                                                           - Hosted by

12.20   Networking Lunch                                                                               Please join us for a drinks reception immediately after
                                                                                                       the panel discussion which closes the first day. This
1.30    Cold Chain Distribution in Clinical Home Care                                                  will be a relaxed and social setting for you to network
        • Overview of clinical home care                                                               with delegates and sponsors and to follow up any
        • The scale of the cold chain distribution challenge                                           questions you may have with speakers
        • Benefits to Pharma, patients & healthcare providers
        Kerry Hinton, General Manager, Healthcare At Home Ltd                   6.40   Close of Day One



                                  Register online at www.coldchain-distribution.com • Alternatively f

   Who should attend?
   • Global Category Manager                • Logistics Manager                 • Senior Transportation Manager        • Principle Supply Chain Analyst
   • Logistics Manager CEE & Asia           • QA Manager                        • Regulatory Affairs Manager           • Clinical Supply Technician
   • GDP Inspector                          • Head of Service                   • Supply Chain Supervisor              • Senior Director
   • Operations Director                    • MD                                • Cold Chain Specialist                • Logistics manager
   • Business Development                   • Product Specialist                • Shipping Specialist                  • Consultant - Supply Chain
     Manager                                • Pharmaceutical Warehouse          • Cold Chain & Shipping                • International Logistics Manager
   • Sr. Pharmaceutical Scientist             Supervisor                          Validation Specialist




  Official Platinum Media Partners                              Supported by
Cold Chain Distribution
distribution.com                                                                                                 Day Two | Tuesday 6th December 2011

    8.30       Re-registration and Coffee                                                                                               Cold Chain Management

    9.00       Chairman's opening remarks
                                                                                                          1.50   Truck carrier selection and their qualification
               Tony Wright, Managing Director, Exelsius Cold Chain Management
                                                                                                                 • Why is it so urgent?
                                      Transportation Planning                                                    • Making the right choice
                                                                                                                 • Pharma requirements
    9.10       Management of transportation of temperature sensitive goods
               • From Guidance to Regulation – how has this been achieved?                                       • Current regulations
               • Importance of Standards – IATA development of a standard label                                  Christoph Frick, PhD Head of Quality Assurance and Pharmaceutical
               • What are the challenges and how are these addressed?                                            Development Qualified Person, Kohlpharma GmbH
               • The way forward and future requirements
               Andrea Graf-Gruber, Manager Business Process & Standards, IATA
                                                                                                          2.30   Auditing Cold chain and temperature-sensitive supply chains
    9.50       Passive Shipper Qualification – A bracketing Approach                                             - A presentation on case studies from around the world.
               • Grouping similar lanes over a summer/winter period                                              • Why temperature sensitive-supply chains fail a GDP audit
               • Bracketing multiple lanes for a single set of qualification data
                                                                                                                 • Where they go wrong
               • Adding lanes without performing additional qualification
               • What to do when things go wrong (off-loads/delays)                                              • Validating your supply chain
               • Quick, visual, determination of shipper performance within a lane                               • Challenges for the industry
               Royce Heap, Cold Chain Manager, Pfizer                                                            • A proactive approach
                                                                                                                 Andrew Meyers, Managing Director, Cold Chain Consultants
    10.30      Morning Coffee

    11.00     When are transportation studies required and when not:                                      3.10   Afternoon Tea
              A Risk based approach
              • Is transportation the same as storeage?
              • Which products need are at risk and protection?                                           3.40   Maintaining data security throughout the distribution network
              • Which trade lanes, modes of transport are at risk?                                               • Role of Standards
              • When do we need to do transportation studies?                                                    • Traceability in Healthcare
              Nigel Cryer, Head Quality Operations, Arrow Pharrma – Watson
                                                                                                                 • Coding in Traceability
              Pharmaceutical Group
                                                                                                                 • Implementing Traceability
    11.40     Utilizing In-transit Temperature Monitoring to Improve the Quality and                             Roger Lamb, Healthcare Manager, GS1 UK
              Efficacy of Biopharmaceuticals: A Case Study
              • Why decreasing revenue streams and the growth of
                                                                                                          4.20   Shipping container 'validation' or 'qualification'; semantics or is there
                biopharmaceuticals are driving optimized supply chains
              • How changes in healthcare delivery will affect the supply chain:                                 a difference?
                chain-of-custody, the last mile and ensuring 100% efficacy                                       • What is shipping container validation?
              • Temperature monitoring options for the supply chain: advantages and                              • What is shipping container qualification?
                disadvantages
              • Improving the supply chain: benefits for manufacturers, distributors,                            • Differences and similarities
                providers and the patient                                                                        • Conclusion
              • Case study: Real-world use cases utilizing in-transit temperature                                Elvia Quiroz Loriega, Cold Chain & Shipping Validation Specialist, Pfizer
                monitoring
                                                                                                                 SA de CV
              Peter Mehring, CEO, Intelleflex

    12.20      Networking Lunch                                                                           5.00   Chairman’s Closing Remarks and Close of Day Two



fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
   PHARMACEUTICAL FORWARD PLANNER
   SEPTEMBER                    Pharmaceutical mHealth        European Pharmaceutical      JANUARY                 Advances and Progress         APRIL                      JULY
   Biomarkers in Clinical       10-11 October 2011            Pricing and Reimbursement    Biomarkers Summit       in Drug Design                Asthma & COPD              KOL Management and MSL
   Trials                                                     31 October-1 November        16-17 January 2012      20-21 February 2012           16-17 April 2012           Best Practice in Europe
   19-20 September 2011         GP Commissioning              2011 (Switzerland)                                                                                            2-3 July 2012,
                                12-13 October 2011                                         Pre-Filled Syringes     MARCH                         MAY                        (Switzerland)
   Biosimilars and Biobetters                                 NOVEMBER                     18-19 January 2012      Imaging in Cancer Drug        “Generics, Supergenerics
   26-27 September 2011         COPD: Novel                   Cell Based Assays                                    Development                   and Patent Strategies”     ADMET
                                Therapeutics and              21-22 November 2011          Social media in the     5-6 March 2012                14-15 May 2012             9-10 July 2012
   KOL Management               Technology Trends                                          pharma industry
   and MSL Best Practice        19-20 October 2011            Clinical Trials in CNS       23-24 January 2012      Superbugs & Superdrugs        Clinical Trial Logistics   Social Media in the
   28-29 September 2011                                       23-24 November 2011                                  - A Focus on Antibacterials   16-17 May 2012             Pharmaceutical Industry
                                Point of Care Diagnositcs -                                FEBRUARY                14-15 March 2012              Pain Therapeutics          9-10 July 2012
   OCTOBER                      Market Opportunities and      DECEMBER                     Parallel Trade                                        21-22 May 2012
   Partnerships with CROs       Technology Trends             Cold Chain Distribution      6-7 February 2012       Controlled Release                                       BioBanking
   3-4 October 2011             24-25 October 2011            5-6 December 2011                                    28-29 March 2012              ADC Summit 2012            11-12 July 2012
                                                                                                                                                 23-24 May 2012
   All conferences take place in central London, UK – unless indicated otherwise in brackets
HALF-DAY POST-CONFERENCE AM WORKSHOP
8.30am – 12.30pm Wednesday 7th December 2011


Workshop A: Practical Management of                                                                                    In association with


Risk in the Pharmaceutical Cold Chain
Workshop Leader: Robert J Hayes, Director, Cold Chain Consultants (UK) Ltd

                                                    Overview of workshop
                                                    The workshop will review current and future regulatory trends in the application of risk-management
  Programme                                         methodologies to the temperature-controlled pharmaceutical supply chain. It will take a practical
  8.30   Registration & Coffee                      look at the tools and techniques for risk assessment and delegates will have the opportunity to work
                                                    through real examples using an established industry model. Delegates will be helped to identify and
  9.00    Welcome & Introductions                   develop solutions to common problems found in the pharmaceutical supply chain.

  9.10    History of risk-based approach in the     Why you should attend:
          pharmaceutical industry                   • Analyse future risk trends                         • Enjoy practical study of risk assessment
                                                    • Share insight with experienced Cold Chain          • Develop solutions to problems in the supply
  9.50    Current and future trends                   specialists                                          chain that your business faces
          • Regulator
          • Industry                                About the workshop host
                                                    The workshop will be led by Eur Ing Robert J Hayes BSc, CEng, FIMechE, FIET
  10.30   Morning Coffee                            Bob has worked in the Pharmaceutical Industry for thirty years. A Chartered Mechanical Engineer,
                                                    his experience includes Production and Engineering Management, New Product Development,
  11.00   Tools and techniques                      Factory Design, Supply Chain Management, Validation and a variety of support functions. Bob is Vice
                                                    Chair of the Pharmaceuticals Technical Activity Committee of the Institution of Mechanical Engineers
                                                    and a Fellow of the Institution.
  11.30   Extended workshop – using FMEA
          Practical solutions to common
          problems                                  About Cold Chain Consultants (UK) Ltd
                                                    Cold Chain Consultants offers unique and specialist services focusing on the operational requirements
  12.30   Close of Workshop                         of temperature sensitive supply chain. Cold Chain Consultants combine skills and experience in
                                                    logistics, temperature measurement, qualification, mapping, cold chain packaging, refrigeration and
                                                    GDP to provide invaluable cold chain knowledge. Cold Chain Consultants are specialists in cold chain
                                                    and temperature sensitive logistics for the pharmaceutical, life sciences and blood product industries.




HALF-DAY POST-CONFERENCE PM WORKSHOP
1.30pm – 5.30pm Wednesday 7th December 2011


Workshop B: A Measured Approach Towards                                                                                In association with


Temperature Controlled Shipments
Workshop Leader: Jane Seeley, Managing Director, GeoStasis Ltd

                                                    Overview of workshop
  Programme                                         The workshop will provide a high-impact, in-room business simulation to accelerate your awareness
  1.30   Registration & Coffee                      and understanding of the Cold Chain. This interactive workshop reviews the challenges that exist as we
                                                    explore the journey, the products and services that are on offer and benefits of a ’Service Management’
  2.00    Welcome & Introductions                   approach to temperature controlled shipments. Following this workshop you will have an appreciation
                                                    of how to benchmark your supply chain in order to drive a continuous improvement culture.
  2.10    Short overview and simulation ‘warm-up’
                                                    Why you should attend:
  2.30    Facilitated simulation that will:         • Learn more about service management in             • Analyse your own solutions and findings and
          • Experience the supply chain in action     the Cold Chain                                       how they can be used in your business
          • Reflect on observations                 • Experience the Cold Chain in action in an          • Increase your awareness and understanding
          • Draw upon conclusions & learning’s        interactive business simulation                      of the Cold Chain
          • Put these learning’s into practice
                                                    About the workshop host
  3.30    Afternoon Coffee                          Jane Seeley has over 28 years’ experience of delivering international best practice and Innovative
                                                    solutions in support of supply chain excellence. Having worked for one of the world’s largest logistics
  4.00    Simulation session completion             companies, responsible for strategic direction, development and delivery of innovative solutions, Jane
                                                    has a comprehensive understanding of the international challenges that exist, the components required
  4.30    Workshop conclusions on how to make       and the alignment of multiple service partners that is critical to prove a true end to end service. This
          a step change towards a measured          understanding along with the vision and passion to mature the management of perishable cargo drove
          approach to temperature controlled        Jane to co-found GeoStasis Ltd.
          shipments.
                                                    About GeoStasis Ltd
  5.30    Close of Workshop                         GeoStasis Ltd brings together best of breed products and services to focus on the provision of quality
                                                    logistics solutions with special attention to performance based operating processes.
Gold Sponsor
                                       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.

Service Features
•      Comprehensive Guidance with Country Specific Import Requirements
•      Global SOP’s for All Temperature Ranges
•      Consultation on Specialty Packaging Solutions
•      Refrigerated Trucking Services
•      GMP Compliant Depot Storage Facilities in Argentina, Australia, Brazil, Chile, China, Colombia, India, Mexico, Peru,
       Russia and South Africa.
•      Expedited Customs Brokerage
•      More than 149 Company Owned Offices Spanning the Globe
www.worldcourier.com




        Sponsored by
                                       ELPRO provide high quality and innovative solutions for Cold Chain Temperature Monitoring which
                                       are easy to use and help reduce cost in the Cold Chain. Our products include the market leading
                                       Libero PDF datalogger and our services include installation, calibration and qualification. With over
                                       20 years experience ELPRO is dedicated to supporting the Pharmaceutical and Biopharmaceutical
                                       industries. www.elpro.com

                                       The Intelleflex® Pharmaceutical Cold Chain Solution provides you with on-demand visibility for
                                       tracking and monitoring the temperature of biologics and other pharmaceuticals throughout the
                                       cold chain. With Intelleflex XC3 Technology™, you can easily and cost-effectively monitor the
                                       temperature and condition of the product every step of the way while it's in-transit – without
                                       unpacking – to ensure efficacy and product quality. For more information, visit www.intelleflex.com

                                       Movianto UK is a subsidiary of the Europe-wide Movianto Group, a leading logistics and distribution
                                       service provider for the pharmaceutical and healthcare industry. With a pallet storage capacity of
                                       over 50,000 spaces as well as seven strategically located warehouses and depots throughout the
                                       country, Movianto UK is able to deliver to every UK hospital and pharmaceutical wholesaler on a
                                       daily basis with its own fleet. The company also delivers cold chain and ambient medicines and
                                       healthcare products to supermarkets, pharmacies, GPs, nursing homes and direct to patients’
                                       homes on a next day basis. The Movianto Group operates in 13 European countries offering a total
                                       storage capacity of 225,000 pallet spaces. Movianto is a business unit of Celesio AG. More
                                       information on www.movianto.com

                                       For over 30 years, QuickSTAT has played a critical role in managing clinical trial logistics for all
                                       phases of research and drug development. We specialise in global shipping of time and
                                       temperature-sensitive clinical research samples, investigational drugs, clinical trial supplies,
                                       vaccines and dangerous goods. www.qicstat.com

                                       Yourway Transport has set the standard for quickness, dependability and personalized service
                                       within the global pharmaceutical logistics industry. Our expertise includes ambient and cold chain
                                       premium courier services, consultation on global transport requirements, customs clearance,
                                       sourcing and provision of shipping supplies and logistical project management. Yourway also
                                       provides an established network of strategically positioned, cGMP Depots, in regions such as Latin
                                       America, Europe, Eastern Europe, India, South Africa, Australia and Asia. The depot network is
                                       supported via a proprietary management system that provides immediate visibility to all
                                       transactions related to their product and studies.                Please visit our website at
                                       www.yourwaytransport.com




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
Want to know how you can get involved?
Interested in promoting your pharmaceutical services to this market?
Contact Margaret Mugema, SMi Marketing on +44 (0)20 7827 6072, or email: mmugema@smi-online.co.uk
COLD CHAIN DISTRIBUTION
                                                    Conference: Monday 5th & Tuesday 6th December 2011, Marriott Regents Park, London, UK

                                                                                              4 WAYS TO REGISTER
                                             www.coldchain-distribution.com
FAX your booking form to +44 (0) 870 9090 712         POST your booking form to: Events Team, SMi Group Ltd, Great Guildford
PHONE on +44 (0) 870 9090 711                         Business Square, 30 Great Guildford Street London, SE1 0HS, UK


                                                                                                           EARLY BIRD □                   Book by 30th September to receive a £100 off the conference price
                                                                                                            DISCOUNT

                                                                                                           CONFERENCE PRICES
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P 012 Cold Chain Distribution

  • 1. REGISTER BY 30TH SEPTEMBER 2011 AND RECEIVE A £100 DISCOUNT EUROPE’S LEADING COLD CHAIN CONFERENCE SMi present their 6th annual conference on… Cold Chain Distribution & New For 2011: Temperature Control Management Monday 5th & Tuesday 6th December 2011 Marriott Regents Park, London KEY SPEAKERS SO FAR INCLUDE: Ray Goff Nigel Cryer Director Head Quality Operations Pfizer Arrow Pharrm Marc Mostinckx Gerald Cavalier Senior Director, Global Logistics Lead Executive Director UCB Cemafroid Elvia Quiroz Loriega Andrea Graf-Gruber Cold Chain & Shipping Validation Specialist Manager, Cargo Business Process and Pfizer Standards International Air Transport Association Stephen Mitchell QA Manager, Quality & Compliance, Sue Lee Logistics Regional Quality Manager, UK & Ireland GSK World Courier WHY ATTEND THIS EVENT: • Analyse the environmental impact and responsibilities within the cold chain. Reusable and recyclable packaging will play an ever more important role to maintain green credentials, but are they cost effective? • Develop your understanding of data management within your cold chain • Understand new regulations - learn how to adapt to new CRT regulations. Gain advantage and avoid costly & time consuming auditing • Explore the possibility of an uninterrupted cold chain - with supply delays causing massive disruption as well as coming at a heavy cost it is more important than ever to effectively contingency plan. Minimising and avoiding delay is critical within the cold chain • Improve your monitoring of wholesaler security. Passing trust and liability on comes with risk but also reward for both parties. Effective management of the relationship is therefore critical • Evolve your understanding of temperature control management. New temperature management regulations effect not just the cold chain, but also room temperature storage, as 'room temperature' can fluctuate wildly and needs to be controlled and supervised correctly PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday 7th December 2011, London Marriott Hotel Regents Park Workshop A: Practical Management of Risk Workshop B: A Measured Approach Towards in the Pharmaceutical Cold Chain Temperature Controlled Shipments Workshop Leader: Workshop leader: Jane Seeley, Managing Director, GeoStasis Ltd Robert J Hayes, Director, Cold Chain Consultants (UK) Ltd 1.30pm - 5.30pm 8.30am - 12.30pm Gold Sponsor Sponsored by www.coldchain-distribution.com Register online and receive full information on all of SMi’s conferences Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
  • 2. Cold Chain Distribution Day One | Monday 5th December 2011 www.coldchain-d 8.30 Registration and Coffee Cold Chain Planning 9.00 Chairman's opening remarks 2.10 Putting a global organization in place to deal with Distribution, Cold Sue Lee, Regional Quality Manager, UK & Ireland, World Courier Chain Management and Shipping Qualification for new products • Understanding the key considerations when creating a fit-for- 9.10 Offsetting fuel costs in clinical distribution purpose logistics department • Outline of current systems used • Identifying, training and organizing an effective global logistics team • 7-8 new ways to offset fuel price increases • Assuring optimal management of shipping solution validation • Modelling your response to price increases • Exploring the UCB cold-chain logistical setup and lessons learned in Ray Goff, Director Vaccine Research, Pfizer the management of a global cold-chain system • Examining the methods, procedures and solutions used in the 9.50 When to and why use a specialist courier? transportation of temperature sensitive shipments and the rationale of the choices made A conversation between Finance and Quality to make the best Marc Mostinckx, Senior Director, Global Logistics Lead, UCB decisions about using a clinical trials transport budget This will consider what to take into account for: 2.50 Data Management in Cold Chain • Difficult and Emerging Markets • Why is it important to collect and manage the temperature data • Temperature Controlled Shipments coming from cold chain monitoring? • Controlled Drugs • What are the challenges with data management in Cold Chain? • Biologics and Biomarkers • What are the solution approaches and what are the advantages and Sue Lee, Regional Quality Manager, UK & Ireland, World Courier disadvantages of the different approaches? • "Big Pharma best practice example": Monitoring and data 10.30 Morning Coffee management process in a complex supply chain Martin Peter, Director, Elpro-Buchs AG Temperature Control Analysis 3.30 Afternoon Tea 11.00 Pharmaceuticals cold chain guidelines update • International transport under controlled temperature for 4.00 Panel Discussion: Emerging regulatory temperature monitoring pharmaceuticals requirements for non cold chain products • Last km of pharmaceuticals cold chain • Discussion on regulatory expectations • Certification initiatives and frames for pharmaceuticals cold chain - Which regulators are active in this area? • Sustainability of pharmaceuticals cold chain - What is in / out of scope? • Approaches to managing the requirements Gérald Cavalier, Executive Director, Cemafroid • What to do with data that has not been collected before & dealing with ‘excursions’ 11.40 Predictive risk-based supply modelling in clinical trials Panel Chair: Stephen Mitchell, QA Manager, Quality & Compliance, • Main uncertainties and risks in CT supply chain process Logistics, GlaxoSmithKline • Predictive patient recruitment modelling tool • Risk-based supply predictive modelling 5.00 Chairman's Closing Remarks • Software tools for supply modelling Prof. Dr. Vladimir Anisimov, Senior Director, Quantitative Sciences, 5.10 Drinks Reception GlaxoSmithKline - UK - Hosted by 12.20 Networking Lunch Please join us for a drinks reception immediately after the panel discussion which closes the first day. This 1.30 Cold Chain Distribution in Clinical Home Care will be a relaxed and social setting for you to network • Overview of clinical home care with delegates and sponsors and to follow up any • The scale of the cold chain distribution challenge questions you may have with speakers • Benefits to Pharma, patients & healthcare providers Kerry Hinton, General Manager, Healthcare At Home Ltd 6.40 Close of Day One Register online at www.coldchain-distribution.com • Alternatively f Who should attend? • Global Category Manager • Logistics Manager • Senior Transportation Manager • Principle Supply Chain Analyst • Logistics Manager CEE & Asia • QA Manager • Regulatory Affairs Manager • Clinical Supply Technician • GDP Inspector • Head of Service • Supply Chain Supervisor • Senior Director • Operations Director • MD • Cold Chain Specialist • Logistics manager • Business Development • Product Specialist • Shipping Specialist • Consultant - Supply Chain Manager • Pharmaceutical Warehouse • Cold Chain & Shipping • International Logistics Manager • Sr. Pharmaceutical Scientist Supervisor Validation Specialist Official Platinum Media Partners Supported by
  • 3. Cold Chain Distribution distribution.com Day Two | Tuesday 6th December 2011 8.30 Re-registration and Coffee Cold Chain Management 9.00 Chairman's opening remarks 1.50 Truck carrier selection and their qualification Tony Wright, Managing Director, Exelsius Cold Chain Management • Why is it so urgent? Transportation Planning • Making the right choice • Pharma requirements 9.10 Management of transportation of temperature sensitive goods • From Guidance to Regulation – how has this been achieved? • Current regulations • Importance of Standards – IATA development of a standard label Christoph Frick, PhD Head of Quality Assurance and Pharmaceutical • What are the challenges and how are these addressed? Development Qualified Person, Kohlpharma GmbH • The way forward and future requirements Andrea Graf-Gruber, Manager Business Process & Standards, IATA 2.30 Auditing Cold chain and temperature-sensitive supply chains 9.50 Passive Shipper Qualification – A bracketing Approach - A presentation on case studies from around the world. • Grouping similar lanes over a summer/winter period • Why temperature sensitive-supply chains fail a GDP audit • Bracketing multiple lanes for a single set of qualification data • Where they go wrong • Adding lanes without performing additional qualification • What to do when things go wrong (off-loads/delays) • Validating your supply chain • Quick, visual, determination of shipper performance within a lane • Challenges for the industry Royce Heap, Cold Chain Manager, Pfizer • A proactive approach Andrew Meyers, Managing Director, Cold Chain Consultants 10.30 Morning Coffee 11.00 When are transportation studies required and when not: 3.10 Afternoon Tea A Risk based approach • Is transportation the same as storeage? • Which products need are at risk and protection? 3.40 Maintaining data security throughout the distribution network • Which trade lanes, modes of transport are at risk? • Role of Standards • When do we need to do transportation studies? • Traceability in Healthcare Nigel Cryer, Head Quality Operations, Arrow Pharrma – Watson • Coding in Traceability Pharmaceutical Group • Implementing Traceability 11.40 Utilizing In-transit Temperature Monitoring to Improve the Quality and Roger Lamb, Healthcare Manager, GS1 UK Efficacy of Biopharmaceuticals: A Case Study • Why decreasing revenue streams and the growth of 4.20 Shipping container 'validation' or 'qualification'; semantics or is there biopharmaceuticals are driving optimized supply chains • How changes in healthcare delivery will affect the supply chain: a difference? chain-of-custody, the last mile and ensuring 100% efficacy • What is shipping container validation? • Temperature monitoring options for the supply chain: advantages and • What is shipping container qualification? disadvantages • Improving the supply chain: benefits for manufacturers, distributors, • Differences and similarities providers and the patient • Conclusion • Case study: Real-world use cases utilizing in-transit temperature Elvia Quiroz Loriega, Cold Chain & Shipping Validation Specialist, Pfizer monitoring SA de CV Peter Mehring, CEO, Intelleflex 12.20 Networking Lunch 5.00 Chairman’s Closing Remarks and Close of Day Two fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 PHARMACEUTICAL FORWARD PLANNER SEPTEMBER Pharmaceutical mHealth European Pharmaceutical JANUARY Advances and Progress APRIL JULY Biomarkers in Clinical 10-11 October 2011 Pricing and Reimbursement Biomarkers Summit in Drug Design Asthma & COPD KOL Management and MSL Trials 31 October-1 November 16-17 January 2012 20-21 February 2012 16-17 April 2012 Best Practice in Europe 19-20 September 2011 GP Commissioning 2011 (Switzerland) 2-3 July 2012, 12-13 October 2011 Pre-Filled Syringes MARCH MAY (Switzerland) Biosimilars and Biobetters NOVEMBER 18-19 January 2012 Imaging in Cancer Drug “Generics, Supergenerics 26-27 September 2011 COPD: Novel Cell Based Assays Development and Patent Strategies” ADMET Therapeutics and 21-22 November 2011 Social media in the 5-6 March 2012 14-15 May 2012 9-10 July 2012 KOL Management Technology Trends pharma industry and MSL Best Practice 19-20 October 2011 Clinical Trials in CNS 23-24 January 2012 Superbugs & Superdrugs Clinical Trial Logistics Social Media in the 28-29 September 2011 23-24 November 2011 - A Focus on Antibacterials 16-17 May 2012 Pharmaceutical Industry Point of Care Diagnositcs - FEBRUARY 14-15 March 2012 Pain Therapeutics 9-10 July 2012 OCTOBER Market Opportunities and DECEMBER Parallel Trade 21-22 May 2012 Partnerships with CROs Technology Trends Cold Chain Distribution 6-7 February 2012 Controlled Release BioBanking 3-4 October 2011 24-25 October 2011 5-6 December 2011 28-29 March 2012 ADC Summit 2012 11-12 July 2012 23-24 May 2012 All conferences take place in central London, UK – unless indicated otherwise in brackets
  • 4. HALF-DAY POST-CONFERENCE AM WORKSHOP 8.30am – 12.30pm Wednesday 7th December 2011 Workshop A: Practical Management of In association with Risk in the Pharmaceutical Cold Chain Workshop Leader: Robert J Hayes, Director, Cold Chain Consultants (UK) Ltd Overview of workshop The workshop will review current and future regulatory trends in the application of risk-management Programme methodologies to the temperature-controlled pharmaceutical supply chain. It will take a practical 8.30 Registration & Coffee look at the tools and techniques for risk assessment and delegates will have the opportunity to work through real examples using an established industry model. Delegates will be helped to identify and 9.00 Welcome & Introductions develop solutions to common problems found in the pharmaceutical supply chain. 9.10 History of risk-based approach in the Why you should attend: pharmaceutical industry • Analyse future risk trends • Enjoy practical study of risk assessment • Share insight with experienced Cold Chain • Develop solutions to problems in the supply 9.50 Current and future trends specialists chain that your business faces • Regulator • Industry About the workshop host The workshop will be led by Eur Ing Robert J Hayes BSc, CEng, FIMechE, FIET 10.30 Morning Coffee Bob has worked in the Pharmaceutical Industry for thirty years. A Chartered Mechanical Engineer, his experience includes Production and Engineering Management, New Product Development, 11.00 Tools and techniques Factory Design, Supply Chain Management, Validation and a variety of support functions. Bob is Vice Chair of the Pharmaceuticals Technical Activity Committee of the Institution of Mechanical Engineers and a Fellow of the Institution. 11.30 Extended workshop – using FMEA Practical solutions to common problems About Cold Chain Consultants (UK) Ltd Cold Chain Consultants offers unique and specialist services focusing on the operational requirements 12.30 Close of Workshop of temperature sensitive supply chain. Cold Chain Consultants combine skills and experience in logistics, temperature measurement, qualification, mapping, cold chain packaging, refrigeration and GDP to provide invaluable cold chain knowledge. Cold Chain Consultants are specialists in cold chain and temperature sensitive logistics for the pharmaceutical, life sciences and blood product industries. HALF-DAY POST-CONFERENCE PM WORKSHOP 1.30pm – 5.30pm Wednesday 7th December 2011 Workshop B: A Measured Approach Towards In association with Temperature Controlled Shipments Workshop Leader: Jane Seeley, Managing Director, GeoStasis Ltd Overview of workshop Programme The workshop will provide a high-impact, in-room business simulation to accelerate your awareness 1.30 Registration & Coffee and understanding of the Cold Chain. This interactive workshop reviews the challenges that exist as we explore the journey, the products and services that are on offer and benefits of a ’Service Management’ 2.00 Welcome & Introductions approach to temperature controlled shipments. Following this workshop you will have an appreciation of how to benchmark your supply chain in order to drive a continuous improvement culture. 2.10 Short overview and simulation ‘warm-up’ Why you should attend: 2.30 Facilitated simulation that will: • Learn more about service management in • Analyse your own solutions and findings and • Experience the supply chain in action the Cold Chain how they can be used in your business • Reflect on observations • Experience the Cold Chain in action in an • Increase your awareness and understanding • Draw upon conclusions & learning’s interactive business simulation of the Cold Chain • Put these learning’s into practice About the workshop host 3.30 Afternoon Coffee Jane Seeley has over 28 years’ experience of delivering international best practice and Innovative solutions in support of supply chain excellence. Having worked for one of the world’s largest logistics 4.00 Simulation session completion companies, responsible for strategic direction, development and delivery of innovative solutions, Jane has a comprehensive understanding of the international challenges that exist, the components required 4.30 Workshop conclusions on how to make and the alignment of multiple service partners that is critical to prove a true end to end service. This a step change towards a measured understanding along with the vision and passion to mature the management of perishable cargo drove approach to temperature controlled Jane to co-found GeoStasis Ltd. shipments. About GeoStasis Ltd 5.30 Close of Workshop GeoStasis Ltd brings together best of breed products and services to focus on the provision of quality logistics solutions with special attention to performance based operating processes.
  • 5. Gold Sponsor 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. Service Features • Comprehensive Guidance with Country Specific Import Requirements • Global SOP’s for All Temperature Ranges • Consultation on Specialty Packaging Solutions • Refrigerated Trucking Services • GMP Compliant Depot Storage Facilities in Argentina, Australia, Brazil, Chile, China, Colombia, India, Mexico, Peru, Russia and South Africa. • Expedited Customs Brokerage • More than 149 Company Owned Offices Spanning the Globe www.worldcourier.com Sponsored by ELPRO provide high quality and innovative solutions for Cold Chain Temperature Monitoring which are easy to use and help reduce cost in the Cold Chain. Our products include the market leading Libero PDF datalogger and our services include installation, calibration and qualification. With over 20 years experience ELPRO is dedicated to supporting the Pharmaceutical and Biopharmaceutical industries. www.elpro.com The Intelleflex® Pharmaceutical Cold Chain Solution provides you with on-demand visibility for tracking and monitoring the temperature of biologics and other pharmaceuticals throughout the cold chain. With Intelleflex XC3 Technology™, you can easily and cost-effectively monitor the temperature and condition of the product every step of the way while it's in-transit – without unpacking – to ensure efficacy and product quality. For more information, visit www.intelleflex.com Movianto UK is a subsidiary of the Europe-wide Movianto Group, a leading logistics and distribution service provider for the pharmaceutical and healthcare industry. With a pallet storage capacity of over 50,000 spaces as well as seven strategically located warehouses and depots throughout the country, Movianto UK is able to deliver to every UK hospital and pharmaceutical wholesaler on a daily basis with its own fleet. The company also delivers cold chain and ambient medicines and healthcare products to supermarkets, pharmacies, GPs, nursing homes and direct to patients’ homes on a next day basis. The Movianto Group operates in 13 European countries offering a total storage capacity of 225,000 pallet spaces. Movianto is a business unit of Celesio AG. More information on www.movianto.com For over 30 years, QuickSTAT has played a critical role in managing clinical trial logistics for all phases of research and drug development. We specialise in global shipping of time and temperature-sensitive clinical research samples, investigational drugs, clinical trial supplies, vaccines and dangerous goods. www.qicstat.com Yourway Transport has set the standard for quickness, dependability and personalized service within the global pharmaceutical logistics industry. Our expertise includes ambient and cold chain premium courier services, consultation on global transport requirements, customs clearance, sourcing and provision of shipping supplies and logistical project management. Yourway also provides an established network of strategically positioned, cGMP Depots, in regions such as Latin America, Europe, Eastern Europe, India, South Africa, Australia and Asia. The depot network is supported via a proprietary management system that provides immediate visibility to all transactions related to their product and studies. Please visit our website at www.yourwaytransport.com 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 Want to know how you can get involved? Interested in promoting your pharmaceutical services to this market? Contact Margaret Mugema, SMi Marketing on +44 (0)20 7827 6072, or email: mmugema@smi-online.co.uk
  • 6. COLD CHAIN DISTRIBUTION Conference: Monday 5th & Tuesday 6th December 2011, Marriott Regents Park, London, UK 4 WAYS TO REGISTER www.coldchain-distribution.com FAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, Great Guildford PHONE on +44 (0) 870 9090 711 Business Square, 30 Great Guildford Street London, SE1 0HS, UK EARLY BIRD □ Book by 30th September to receive a £100 off the conference price DISCOUNT CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee Total □ Conference & Half-Day Workshop £1998.00 +VAT £2397.60 □ Conference and Two Half-Day Workshops £2597.00 + VAT £3116.40 □ Conference only £1399.00 + VAT £1678.80 □ Half-Day Workshop only £599.00 + VAT £718.80 Unique Reference Number □ Two Half-Day Workshops only £1198.00 + VAT £1437.60 Our Reference LVP-012 Workshop A □ Workshop B □ PROMOTIONAL LITERATURE DISTRIBUTION DELEGATE DETAILS □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80 Please complete fully and clearly in capital letters. 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