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7th Annual

Cold Chain      Management
                                                                                                                           TM

& Temperature Control Summit
Strengthening End-to-End Cold Chain Practices to Enhance the Most Critical Steps in
Distribution, Packaging and Compliance of Temperature-Sensitive Pharmaceuticals
February 24 – 27, 2009            •    Four Seasons Hotel Toronto                 •    Toronto, Canada


                    Co-located with Green Packaging – see page 10 for more details

Conference Co-Chairs:
           Allan Reynolds                                                 Rafik H. Bishara, PhD
           Vice President, Industry & Member Relations                    Technical Advisor, Chair, Pharmaceutical Cold
           CANADIAN ASSOCIATION FOR PHARMACY                              Chain Interest Group (PCCIG)
           DISTRIBUTION MANAGEMENT (CAPDM)                                PARENTERAL DRUG ASSOCIATION (PDA)


Full-day Intensive Training Class on Reengineering Your Cold Chain
by Sherman Cheung, Director of Supply Chain Management, Sanofi Pasteur

Hear from Canadian Pharmaceutical                            Attend and Learn:
companies and Regulatory Agencies:                               The Latest Update from Health Canada on the Revisions to
                                                             •


                                                                 Guide-0069
Abbott Laboratories             Medicines and Healthcare
                                Products Regulatory              Meet Temperature Challenges during Packaging,
                                                             •
American Red Cross
                                Agency (MHRA)                    Warehousing and Transportation
Blueye, LLC
                                Sea Star Line, LLC               How to Maintain Quality in Downstream Distribution and the
                                                             •
Canada Border Services
                                Talecris Biotherapeutics,        Last Miles of the Cold Chain
Agency (CBSA)
                                Inc.
Canadian Association of                                          Ensuring Optimal Cold Chain Management through the
                                                             •

                                Transportation Security
Chain Drug Stores (CACDS)                                        Canadian Distribution Networks
                                Administration (TSA)
Catalent Pharma Solutions                                        Best Practices for Cross-Border Transport and Current Global
                                                             •

                                University of Florida
Franwell Inc.                                                    Regulatory Requirements
                                US Pharmacopeia (USP)
Health Canada
                                                                 Avoiding Excursions and Systems for Ensuring Product Quality
                                                             •

Johnson & Johnson
                                                                 RFID Systems and ePedigree Compliance
Medical Products Shared                                      •


Distribution Centre


Lead Sponsor:                         Sponsors:



Badge Sponsor:



                                                            www.coldchainpharm.com
Sponsors and Media Partners

    Sponsors

    Lead Sponsor:                                                              Badge Sponsor:




                              http://www.alternatives-tech.com                                    http://customcritical.fedex.com




    Sponsors:



                http://www.mnthermalscience.com      http://www.greenboxsystems.com             http://www.kn-portal.com




                     http://www.polyair.com                      http://www.temptimecorp.com            http://www.envirotainer.com




                   http://www.sensitech.com                          http://www.cryopak.com          http://www.worldcourier.com




    Media Partners:




                                     “I’ve learned significant information for cold chain that I can
                                          immediately apply within my company’s operations”
                                         -QA Logistics Program Manager, Abbott Laboratories




    1-800-882-8684 • www.coldchainpharm.com
2
7th Annual
                                                                                                             Who Will Attend:
Cold Chain      Management                                                                                   Pharmaceutical professionals in
                                                                                                             Supply Chain, Distribution, QA,
                                                                                                        TM

& Temperature Control Summit                                                                                 Regulatory, Transportation,
                                                                                                             Packaging, and Security in the
                                                                                                             following industries:
Strengthening End-to-End Cold Chain Practices to Enhance the Most Critical Steps in
Distribution, Packaging and Compliance of Temperature-Sensitive Pharmaceuticals                                  Pharmaceutical &
                                                                                                             •


                                                                                                                 Medicine Manufacturing
February 24-27, 2009             •   Four Seasons Hotel Toronto          •   Toronto, Canada
                                                                                                                 Bio-technology
                                                                                                             •



                                                                                                                 Medical Laboratories
                                                                                                             •


           Dear Colleague,                                                                                       Transportation
                                                                                                             •



                                                                                                                 Logistics, Cargo & Storage
                                                                                                             •
          With the overwhelming complexity
                                                 of assuring product integrity through
                                                                                       out the
          distribution chain, it is necessary to
                                                 bring together industry regulators, end                         Government & Military
                                                                                                             •
                                                                                         -users and
          vendors to discuss the critical issues
                                                 impacting the pharmaceutical cold
                                                                                      chain. For this
          reason, IQPC has brought timely, well                                                                  Healthcare & Personal
                                                                                                             •
                                                    thought-out programs to the pharma
                                                                                          ceutical
          cold chain industry for the past seve                                                                  Care Stores
                                                 n years.
                                                                                                                 Public Health
                                                                                                             •
           Building on the success of last year’s
                                                   Sixth Annual event in Canada, as well
                                                                                         as our                  Administration
          enormously successful U.S. meeting
                                                  in Philadelphia each September, the
                                                                                      Seventh
          Annual Canada Cold Chain Managem
                                                     ent and Temperature Control Summit                          Medical Equipment &
                                                                                                             •
                                                                                          will
          address the most urgent concerns and
                                                     challenges of the North American mar
                                                                                                                 Supplies Manufacturing
                                                                                           ketplace
          for the distribution of temperature-sen
                                                    sitive pharmaceutical products.

      While focusing on the always importa
                                               nt topics – how to monitor, control
                                                                                   and maintain
      temperatures of bio pharmaceutical
                                             products throughout the supply chai
                                                                                  n, from
      warehouse, wholesale, pharmacies
                                                                                                             Industry
                                            and hospitals to the end user – this
                                                                                 event will also
      provide delegates with real life solu
                                           tions and techniques for:
                                                                                                             Breakdown:
           Implementing or updating an end-to-e
      •
                                                    nd cold chain system that complies
                                                                                         with the
           latest regulations, supports corporat
                                                e best practices and fits into your cost
                                                                                        -benefit
           analysis
          Wisely choosing partners in your chai
  •
                                                  n, including transportation, packagin
                                                                                        g, storage
          and what is necessary to have in your
                                                   agreement
          Monitoring and managing data
  •

          Complying with international regulatio
  •
                                                   ns and understanding what is required
                                                                                            when
          product crosses borders
          Effectively dealing with challenges inclu
  •
                                                   ding excursions and audits
                                                                                                             ■ 56% Pharmaceutical
 We look forward to seeing you this                                                                                & Medicine Manufacturers
                                    February in Toronto and welcoming
                                                                      you to IQPC’s                          ■ 4%
 Seventh Annual Cold Chain Managem                                                                                    Bio-Technology
                                      ent and Temperature Control Summit!
                                                                                                             ■ 4%     Medical Laboratories
                                                                                                             ■ 4%     Transportation
                                                                                                             ■ 4%     Logistics, Cargo and Storage
                                                                                                             ■ 4%     Government and Military
                                                                                                             ■ 3%     Health and Personal Care
                                                                                                                      Stores
Lisa Ringlen
                                                                                                             ■ 3%     Public Health Program
Senior Conference Director
                                                                                                                      Administration
IQPC
                                                                                                             ■ 2%     Medical Equipment and
                                                                                                                      Supplies Manufacturing
                                                                                                             ■ 16% Other



Sponsors:                                                                                                                                            3
Benefit from attendee interaction!

       The following companies attended last year’s event:
       Abbott Laboratories Canada                        Form Solutions                                       Patheon, Inc.
       Abbott Laboratories, Inc.                         GE Healthcare                                        Patient Direct
       Alberta Health and Wellness                       Genzyme Canada                                       Pfizer Canada, Inc.
       Allergan, Inc.                                    GlaxoSmithKline                                      Pharmaceutical Partners of Canada
       Almac Clinical Services                           Health Canada                                        PharmEng Technology, Inc.
       Almac Group                                       Hoffmann-La Roche Limited                            Polyair
       Alternatives Technology Pharma                    Hospira                                              Public Health Agency of Canada
       Amerisource Bergen                                Information Mediary Corporation                      Quikx Transportation, Inc.
       Baxter Corporation                                International Safe Transit Association               Roche Diagnostics
       BCCDC                                             Johnson & Johnson Centocor                           Safety Express - Toronto
       Biomerieux Canada, Inc.                           Johnson & Johnson GPSG                               Sanofi Aventis
       Bristol Meyers Squibb                             Johnson & Johnson Medical, Inc.                      Sanofi Pasteur
       Calea Ltd.                                        Materials Management & Distribution                  Sanofi Pasteur Canada
       Canadian Association for Pharmacy Distribution    McKesson Canada                                      Schering Plough
       Management                                        McKesson Logistics Solutions                         Sensitech
       Canadian Blood Services                           Merck & Co.                                          Shire Pharmaceuticals
       Cangene Corporation                               Merck Frosst Canada                                  SNC Lavalin Pharma
       Central Medical Equiptment Depot                  Meyers                                               TCP Reliable, Inc.
       Ciba Vision                                       MHRA                                                 Thermal & Protective Packaging, Inc.
       Ciba Vision Canada, Inc.                          Michigan State University                            ThermoSafe Brands
       City Wide Packaging Solutions, Inc.               Ministry of Health & Long-Term Care                  Transition Therapeutics, Inc.
       Department of National Defense                    Minnesota Thermal Science                            US Customs and Border Protection
       Defense Logistics Agency (DLA)                    Novo Nordisk Canada, Inc.                            Watson Pharmaceuticals, Inc.
       Dynamex Canada Corp                               Novopharm                                            World Health Organization
       EMD Serono Canada, Inc.                           Oncothyreon                                          Wyeth Laboratories
       Entropy Solutions, Inc.                           Ontario Ministry of Health                           Wyeth Pharmaceuticals
       Envirotainer




    Pre-Conference Training Class                                                                        Tuesday, February 24, 2009


             Registration for Training Class & Coffee                                         Session 3: The Distribution Itinerary
    7:15
                                                                                              • Why itinerary is critical to cold chain performance

                                                                                              • Itinerary Design Criteria

    8:00 am – 4:45 pm                                                                         • The Transportation Mode

                                                                                              • The Carriers
             REVIEW, REDESIGN AND REENGINEERING OF                                            • Routing

             COLD CHAIN MANAGEMENT                                                            Special Case Study Guest:
                                                                                              A Representative of KUEHNE + NAGEL LTD.
             Workshop Leader:
             Sherman Cheung, Director of Supply Chain Management,
             SANOFI PASTEUR                                                                   Lunch
                                                                                   12:00

             Session 1: Seven Deadly Myths - The Right and Wrong of
                                                                                              Session 4: The Temperature Monitoring and Tracking
             Cold Chain Management                                                            • Why monitor and track temperature during transportation
             • Some very critical “Myths” inappropriate traditional
                                                                                              • Types of monitoring available in the market
               approaches and concepts that seriously affect the                              • Types of monitoring that should be used in different

               performance Cold Chain Transportation                                            shipment modes
             • The Wrong and Right approaches                                                 • How to operate different types of monitors

                                                                                              • How to interpret the temperature during the shipment

                                                                                              • Cold Chain deviation and product loss
             Session 2: The Transporters – with an Extensive
             Examination of Airline Carrier Capabilities and
                                                                                              Session 5: The Re-engineering of Cold Chain Management
             Compliance Abilities
                                                                                              • Logistics role in Cold Chain management
             • Your own Logistics Personnel
                                                                                              • Cold Chain performance is not guaranteed
             • Freight Forwarder – Value-added or Road Block process
                                                                                              • Challenges we are facing
             • Carriers
                                                                                              • Partnership – why and how?
             • Airlines – comparing, contrasting and evaluating our options
                                                                                              • Training and Education needed for your internal staff and
             • On the road
                                                                                                external partnerships
             • Courier


             Special Case Study Guest:                                                        End of Training Class
                                                                                   4:45
             A Representative of AIR FRANCE




    1-800-882-8684 • www.coldchainpharm.com
4
Pre-Conference Workshops                                                                          Wednesday, February 25, 2009


            8:00 am – 11:00 am             7:15 am Registration for Workshop A (Coffee will be served)
 A
            NEW TECHNOLOGIES TO MEET TEMPERATURE CHALLENGES DURING WAREHOUSING
            AND TRANSPORTATION
   In North America, warehousing and transportation of Drug Products             traceability of products to meet new regulations such as ePedigree is
   are now regulated by guidelines and standards such as Health                  at our door. In this presentation, we explore the latest available
   Canada’s HPFBI Guide-0069, Parenteral Drug Association’s Technical            solutions for a safe, efficient and traceable supply chain, and how to
   Guide 039, United States Pharmacopeia’s Chapter <1079>,                       ensure the implementation of the proper technologies. This
   International Safe Transit Association (ISTA) Test Procedures 5B and          comprises monitoring and track & trace solutions such as, time-
   7D, American Society for Testing and Material (ASTM) Standard Test            temperature indicators, data loggers, sensor technologies (RF, RFID,
   Method D 3103-99, ePedigree and other regulations.                            conventional and others), and various models of insulated shippers
                                                                                 and refrigerants.
   It becomes increasingly crucial to use the right technologies in order
   to maintain product temperature/humidity during warehousing and               Presented By:
   transportation and to monitor and control the cargo temperature               Jean Bédard, Chief Executive Officer, ALTERNATIVES
   variances in flight and on the road. The need for enabling                    TECHNOLOGIE PHARMA


            11:15 pm – 2:15 pm             11:00 am Registration for Workshop B (Box Lunch will be served)
 B
            TEMPERATURE & TRANSPORTATION: HOW TO MAINTAIN QUALITY IN THE COLD CHAIN
       The transportation of temperature-controlled product                          How concepts of validation can be applied to enhance the
   •                                                                             •

       Best practices that support the pharmaceutical industry’s regulatory          consistency and quality of cold chain transportation
   •

       compliance requirements, including:                                           Case studies of truck validation and air transportation
                                                                                 •

        • The benefits of custodial control: How to avoid problems with              environments.
          multiple handlers and protect Pedigree during transport                    • Relative strengths and weaknesses of various approaches at

        • How to gain complete visibility of temperature conditions during             common temperature ranges: 2-8° C, deep frozen and
          and after the shipment                                                       controlled room temperature.
        • Contingency plans: designing transport systems to enable

          effective, preventative intervention                                   Presented By:
       Transportation carrier quality systems: What you should expect            Karl Kussow, Quality & Validation Manager,
   •

       from your carrier                                                         FEDEX CUSTOM CRITICAL


            2:30 pm – 5:00 pm              2:15 pm Registration for Workshop C
 C          MEETING TRANSPORT SERVICE PROVIDER OBLIGATIONS FOR MANAGING TEMPERATURE
            SENSITIVE SHIPMENTS
   This workshop reviews the latest changes to industry guidance and                   Training
                                                                                     •

   the implication for transport service providers. Meeting the industry’s             Facilities and equipment
                                                                                     •

   requirements for an effective quality management system is                        • Corrective and preventative actions (CAPA)

   discussed in detail with a case study of an approach taken by a                   • Audit program

   platform provider to ensure effective management of their solution.               Case study: Vendor driven training and quality accreditation
                                                                                 •

   • Review of current industry guidance (PDA Technical Report #39 /                 program (QEP)
     Health Canada 0069 / IATA Perishable Cargo Manual)
   • Developing a Quality Management System                                      Presented By:
      • Personnel                                                                Christopher Fore, Technical Support Manager, ENVIROTAINER, INC
      • Processes and procedures




            5:15 pm – 8:15 pm              5:00 pm Registration for Workshop D (Dinner will be served)
 D          COMPLETE TEMPERATURE-CONTROLLED PACKAGING SOLUTIONS FROM NEEDS
            ASSESSMENT TO PACKAGE QUALIFICATION
   This comprehensive workshop is tailored for people responsible for            What You Will Learn:
   cold chain package design and shipping of pharmaceuticals. It will            • Walk away better prepared to define scope, schedule and cost of

   include detailed steps required for success in selecting and designing          your cold chain project
   temperature controlled shipping solutions. Participants will gain a           • Attain knowledge of design choices of refrigerants, insulation and

   precise understanding of the most thorough and effective approach               their interaction
   to the critical details related to packaging from design, testing and         • Gain an understanding of the elements and advantages of well

   through to qualification.                                                       defined test protocol
                                                                                 • Obtain a clear concept of the package testing and qualification

   How You Will Benefit:                                                           process
   • Elements required to define the project

   • New materials available to reduce packaging and their tradeoffs             Presented By:
   • Methods to establish temperature profiles                                   Anthony Alleva, Project Engineer, TCP/CRYOPAK
   • Understanding the options and issues for CRT, refrigerated, and             Mike Paterno, Project Manager, TCP/CRYOPAK
     frozen shipments and relating them to the Canadian market


                Pre-Conference Workshops conclude
   8:15 pm

Sponsors:                                                                                                                                                 5
Main Conference Day One                                                                           Thursday, February 26, 2009


              Registration & Coffee                                             11:00 am PANEL   DISCUSSION:
    7:30 am
                                                                                          DOWNSTREAM DISTRIBUTION AND THE LAST
                                                                                          MILES OF THE COLD CHAIN
              Welcome from IQPC
    8:15 am                                                                                   Provincial Government Level and the last mile, what’s going
                                                                                          •


                                                                                              on below the federal level?
                                                                                              Retail Pharmacies: What procedures are you using?
                                                                                          •

              Opening Remarks from the Chairperson
    8:30 am
                                                                                              How can the manufacturer monitor the product at the
                                                                                          •


                                                                                              individual pharmacy, wholesaler, physician, hospital, long-
              Day One Chair:
                                                                                              term care facility, community health center, etc.?
              Allan Reynolds
                                                                                              Maintaining procedures in rural areas
              Vice President, Industry & Member Relations                                 •


              CANADIAN ASSOCIATION FOR PHARMACY DISTRIBUTION
                                                                                          Panelists:
              MANAGEMENT (CAPDM)
                                                                                          Heather Tyrrell
                                                                                          Director, Membership & Trade Issues
                                                                                          CANADIAN ASSOCIATION OF CHAIN DRUG STORES
              OPENING KEYNOTE: UPDATE ON GUIDE-0069
    8:45 am
                                                                                          (CACDS)
              Sarah Skuce
                                                                                          Ted Prusik
              Compliance Specialist
                                                                                          Senior Vice President
              HEALTH CANADA
                                                                                          TEMPTIME CORPORATION

              Morning Networking Break
    9:15 am                                                                               Arminda Montero
                                                                                          QA Logistics Program Manager
                                                                                          ABBOTT LABORATORIES, INC.
    10:00 am PANEL DISCUSSION:
              REGULATORY AGENCIES UPDATE
              With so many rules, regulations and guidelines to consider,       12:00 pm Networking          Lunch
              how do you choose the best plan for your organization for
              maintaining compliance? This discussion provides a one-stop
                                                                                          CASE STUDY PRESENTATION:
              place for all the latest on regulations and where you need to     1:30 pm
                                                                                          STORAGE AND DISTRIBUTION OF DRUG
              be now and in the foreseeable future.
                                                                                          PRODUCTS: ENSURING OPTIMAL COLD CHAIN
              • What is going on with revisions to current GMPs? Update on


                                                                                          MANAGEMENT THROUGH THE CANADIAN
                GUIDE-0069, USP 1079
                                                                                          DISTRIBUTION NETWORKS
              • New regulations on storage, handling and distribution of


                drug samples & mail-order drugs                                           In this presentation, Alternatives Technologie Pharma presents
              • What is expected by regulatory agencies?                                  the Cold Chain Compliance program that was applied
              • What is next on the regulatory horizon?                                   progressively, globally and site by site, to increase the level of
                                                                                          compliance of the five biggest wholesalers in Canada including
              Moderator:
                                                                                          35 distribution centers across the country. The implementation
              Allan Reynolds
                                                                                          of such a Cold Chain Compliance program enabled these five
              Vice President, Industry & Member Relations
                                                                                          major Canadian pharmaceutical wholesalers to upgrade their
              CANADIAN ASSOCIATION FOR PHARMACY DISTRIBUTION
                                                                                          cold chain management and to fully comply with the various
              MANAGEMENT (CAPDM)
                                                                                          guidelines for temperature control of drug products during
                                                                                          storage and transportation.
              Panelists:
              Sarah Skuce
                                                                                          Presenter:
              Compliance Specialist
                                                                                          Jean Bédard
              HEALTH CANADA
                                                                                          Chief Executive Officer
                                                                                          ALTERNATIVES TECHNOLOGIE PHARMA
              Mary G. Foster
              Packaging and Storage Expert Committee Member
              US PHARMACOPEIA
                                                                                          “Very knowledgeable speakers.
                                                                                           Very relevant for distribution”
                                                                              - Director, Distribution Operations, Pfizer Canada Inc.

    1-800-882-8684 • www.coldchainpharm.com
6
Main Conference Day One                                                                         ...continued


            PANEL DISCUSSION:                                                                  APPROACH FOR DELIVERING QUALITY
2:15 pm
            SEA TRANSPORT OF BIOPHARMACEUTICAL                                                 PRODUCTS AND ENSURING PATIENT SAFETY
            PRODUCTS                                                                           Industry leaders are banking cold chain data and statistically
                Exploring cost-effective options by sea transportation                         evaluating the performance of their supply chain over time
            •


                • Pros and cons of sea transportation
                                                                                               with the specific goals of improving supply chain performance
                    Temperature dynamics during the whole distribution chain                   and overall efficiency, as well as, lowering costs and
                •


                    Temperature deviation when containers are quot;unpluggedquot;                      documenting and mitigate risks through the development of
                •


                    during transfers between sea and land carriers                             improved Standard Operating Procedures (SOPs). New trends
                  Potentials and benefits of a sea/air/ground integrated                       point toward incorporating the Quality by Design (QbD)
                •


                  distribution system                                                          framework into overall Good Cold Chain Management
                Monitoring and new generation of sea containers                                Practices by monitoring and evaluating cold chain process
            •

                • How to monitor ocean container shipments of product
                                                                                               performance characteristics scientifically to ultimately ensure
                  (real time vs data loggers)                                                  product quality and patient safety.
                    How to achieve temperatures colder than -20°C for both                     This presentation will review the concepts above and provide case
                •


                    regulatory documentation requirements and for insurance                    study examples to demonstrate the effectiveness of such programs.
                    claim purposes
                                                                                               Presenters:
                    What type of alarm devices could be incorporated into
                •

                                                                                               Mark Maurice
                    containers to alert the shippers/drivers that the air/products
                                                                                               Senior Project Manager
                    temperature is warming?
                                                                                               SENSITECH COLD CHAIN VISIBILITY ADVISORS
                    Can perfect temperature setting be achieved?
                •


                    New generation of sea containers (technologies, features)
                •
                                                                                               Neritan Mustafa
                Ocean container owners/operators perspectives on CCM
            •
                                                                                               Life Sciences Program Manager
                • How CCM is achieved during the whole distribution?
                                                                                               SENSITECH, INC.
                • What can be done during ground and sea to assure good


                  CCM
                                                                                               EXTENDING GXP BEYOND THE FOUR WALLS:
                    What users should know about sea transportation                  4:45 pm
                •


                                                                                               GOOD COLD CHAIN MANAGEMENT
                    operations that may compromise CCM
                                                                                               PRACTICES ON WHEELS
                    SOP for temperature sensitive products transported by sea
                •


                                                                                               In this presentation, the speaker will discuss how a cold chain
            Panelists:
                                                                                               management program evolved through the partnering and
            Jean Vezina
                                                                                               collaboration of manufacturer and carrier, with a focus on;
            Chief Operating Officer                                                            • Building a relationship with a cold chain provider

            BLUEYE LLC                                                                         • Aligning strategy with capability


                                                                                               • Developing clear expectations and responsibilities
            Frank Peake
                                                                                                  • Contracts, SOP’s and Quality Agreements
            President & Chief Operating Officer
                                                                                               • Defining Success
            SEA STAR LINE, LLC
                                                                                                  • Measuring performance through KPI’s

            Jean Pierre Emond                                                                     • Continuous improvement

            Professor & Co-Director, Research Center for Food Distribution
            & Retailing                                                                        Presenter:
            UNIVERSITY OF FLORIDA                                                              Jim Bacon
                                                                                               Director of Global Demand Planning & Customer Operations
                                                                                               TALECRIS BIOTHERAPEUTICS, INC.
            Afternoon Networking Break
3:15 pm


                                                                                     5:30 pm – 6:30 pm
            MANUFACTURER TO CONSUMER – DEALING
4:00 pm
            WITH TEMPERATURE CONTROL CHALLENGES
                                                                                     Networking Cocktail Reception for
            AND REGULATIONS: QUALITY BY DESIGN (QBD)
                                                                                     all delegates
            AND GOOD COLD CHAIN MANAGEMENT
                                                                                     After a day of learning and discussions, join your
            PRACTICES (GCCMP) - A SCIENCE-BASED
                                                                                     colleagues from across all disciplines to exchange ideas
                                                                                     and network in an informal environment.




Sponsors:                                                                                                                                                          7
Main Conference Day Two                                                                               Friday, February 27, 2009


              Registration & Coffee                                                                Morning Networking Break
    8:00 am                                                                         10:00 am



              Opening Remarks from the Chairperson                                  10:45 am PANEL   DISCUSSION:
    8:30 am
                                                                                               A HOLISTIC APPROACH TO GOOD COLD
              Day Two Chair:
                                                                                               CHAIN FROM THE PHARMACEUTICAL
              Rafik H. Bishara, PhD
                                                                                               MANUFACTURERS’ PERSPECTIVE
              Technical Advisor, Chair, Pharmaceutical Cold Chain Interest                     Which companies have successfully introduced a cold chain
              Group (PCCIG)                                                                    program and what were the keys to cost-effective
              PARENTERAL DRUG ASSOCIATION (PDA)                                                compliance? What are the pharmaceutical companies
                                                                                               experiencing the most trouble with? What specifically do they
                                                                                               need from vendors?
              PANEL DISCUSSION:                                                                • Avoiding excursions: Systems for ensuring product quality
    8:45 am
                                                                                               • What are the key factors that compromise your cold chain
              CROSS-BORDER TRANSPORT/OVERVIEW OF
                                                                                                 and cause temperature excursion?
              INTERNATIONAL MARKETS
                                                                                               • Avoiding control gaps when product moves from one piece
              Pharmaceutical supply chains are global. This discussion will focus
                                                                                                 of the chain to the next: i.e., from the plane/ship to the
              on how to maintain/control temp of international shipments in a
                                                                                                 truck and from the truck to the warehouse
              cost-effective manner that meets regulatory compliance, including
                                                                                               • How much monitoring is necessary?
              the keys to expanding your supply chain overseas.
                                                                                               • Dealing with excursions: What data is needed? What are
              • Exploring current global regulatory requirements

                                                                                                 the remedies? How to justify/investigate excursions
              • Comparing and contrasting regulations, procedures and best


                practices: Which countries and regions have the best
                                                                                               Panelists:
                practices and how can the Canadian industry adopt them?
                                                                                               Eric Malouin
              • Regulatory harmonization: Overcoming inconsistent laws &

                                                                                               Distribution & Operations Supervisor
                regulations
                                                                                               ABBOTT LABORATORIES, INC.
              • International shipments in and out of the Canadian market,


                especially to/from Europe and India
                                                                                               Silvia Castellarin
              • Customs procedures
                                                                                               Logistics Systems Manager
              • International packaging regulations

                                                                                               JOHNSON & JOHNSON MEDICAL PRODUCTS SHARED
              • Expanding your supply chain into emerging markets

                                                                                               DISTRIBUTION CENTRE
              • International ground transport

              • Security issues involved in cross-border transport of
                                                                                               Jim Bacon
                pharmaceuticals
                                                                                               Director of Global Demand Planning & Customer Operations
                                                                                               TALECRIS BIOTHERAPEUTICS, INC.
              Moderator:
              Rafik H. Bishara, PhD
              Technical Advisor, Chair, Pharmaceutical Cold Chain Interest
                                                                                    11:45 am OUTSOURCING  GOOD COLD CHAIN
              Group (PCCIG)
                                                                                               MANAGEMENT PRACTICES
              PARENTERAL DRUG ASSOCIATION (PDA)
                                                                                                   Cold chain regulations, pharmacopeial standards and industry
                                                                                               •

              Panelists:                                                                           best practices
              Boriana Cavicchia                                                                    Storage versus distribution temperature(s) for sensitive
                                                                                               •


              Manager, Systems Quality, Biomedical Services                                        medicinal products
                                                                                                   Distribution temperature acceptance criteria for cold chain
              AMERICAN RED CROSS                                                               •


                                                                                                   products
              Mau'veen Dayrell-Johnson                                                             The outsourcing program
                                                                                               •


              Senior Officer, Trade Compliance                                                     Handling, storage and transportation/distribution of
                                                                                               •


              CANADA BORDER SERVICES AGENCY (CBSA)                                                 temperature sensitive medicinal products
                                                                                                       • Temperature profile development: Ambient, hot and

              Ian Holloway                                                                                cold profiles
              Manager, Defective Medicines Report Centre                                               • Packaging development: Qualification per Technical


              MEDICINES AND HEALTHCARE PRODUCTS REGULATORY                                                Report 39
              AGENCY (MHRA)                                                                            • Important factors

                                                                                                              — Matrixing product packaging

              A Representative of TRANSPORTATION SECURITY                                                     — Pack-outs

              ADMINISTRATION (TSA) AIR CARGO SECURITY                                                         — Monitoring

                                                                                                              — Performance qualification




    1-800-882-8684 • www.coldchainpharm.com
8
Main Conference Day Two                                                                           ...continued


                            Documentation requirements                                     ePedigree compliance
                         —                                                             •


                            Training                                                       Effective tracking techniques to minimize time wastage
                         —                                                             •


                The outsourcing program
            •
                                                                                           Determining the weak link in your supply chain
                                                                                       •




            Presenter:                                                                 Panelists:
            Rafik H. Bishara, PhD                                                      Jeff Wells
                                                                                       President & Chief Executive Officer
            Technical Advisor, Chair, Pharmaceutical Cold Chain Interest
                                                                                       FRANWELL, INC.
            Group (PCCIG)
            PARENTERAL DRUG ASSOCIATION (PDA)
                                                                                       Thomas Reese
                                                                                       Business Development - RFID
                                                                                       MOTOROLA ENTERPRISE MOBILITY DIVISION
12:30 pm Networking           Lunch
                                                                                       Jean Pierre Emond
                                                                                       Professor & Co-Director, Research Center for Food Distribution
                                                                                       & Retailing
            Coffee & Dessert in the Exhibit Hall
1:30 pm
                                                                                       UNIVERSITY OF FLORIDA


            PANEL DISCUSSION:                                                          SMALL GROUP/ROUNDTABLE DISCUSSIONS
2:15 pm                                                                      3:15 pm
            DATA MANAGEMENT SYSTEMS                                                        Sustainability in Your Cold Chain Procedures
                                                                                       •


                                                                                           Pharmaceutical Supply Chain Security
                                                                                       •
            Good data management can improve your inventory
                                                                                           The Role of Pharmacies in Maintaining the Cold Chain
                                                                                       •
            management, making recalls more efficient and providing the
            means to authenticate temperature management and identify
            counterfeit drugs. What options are available and which will               Roundtable Summaries:
                                                                             4:00 pm
            work best for your organization?                                           Takeaways from Each Small Group Discussion
                Radio-frequency identification (RFID) systems: How do they
            •


                work? Are they the best option?
                                                                                       Closing Remarks and Program Concludes
                                                                             4:15 pm
                Other electronic product codes: What else is available?
            •




                                  “Good presentations with emphasis on real-life issues and work trends”
                                             – Quality Advisor, Janssen Pharmaceuticals NV

                                                   “One of the best conferences I have attended”
                                                    – QA Associate Director, Johnson & Johnson

                         quot;Excellent presentations on Supply Chain involving 3rd party transportation carriers.quot;
                                              – Materials Supervisor, Bristol Myers Squibb

                                          quot;I’m looking at all of the vendors for possible applications.quot;
                                                     – Sr. Transportation Analyst, Covidien

                                        “Well prepared and communicated info on all topics discussed”
                                                 -Warehouse Supervisor, Bristol Myers Squibb




Sponsors:                                                                                                                                               9
Register by
                                                                                      12/19/08 and
                                                                                      SAVE $500




Green
Packaging                                                                   February 25-27, 2009
                                                                            Toronto, Canada
                                                                       TM




                                        Rethinking the Sustainable Packaging Paradigm:
                                                    Emphasizing Good Business Practice
                                                       as the Rationale for Going Green




Benefits of Attending:
    Learn about the real cost-saving potential of
•

    sustainable packaging

    Define what it really means to be green
•


    Learn about the newest green technology, materials and solutions
•


    Understand the emerging world of sustainability regulations
•


    Examine the cost of sustainability – What is the ROI of going green?
•
                                                                                Green
                                                                                Packaging
For more information on Green Packaging
                                                                                is co-located with
or to download the complete brochure, visit
                                                                                7th Cold
www.iqpc.com/us/green
                                                                                Chain Management
                                                                                and Temperature
www.iqpc.com/us/green                                                           Control Summit
7th Annual

    Cold Chain      Management
                                                                                                  Registration information
                                                                                TM

    & Temperature Control Summit
      Pricing                                                 Book and Pay By    Book and Pay By    Book and Pay By      Book and Pay By         Book and Pay By            Standard
                                                                Nov. 21, 08         Dec. 5, 08        Dec. 19, 08           Jan. 9, 09             Jan. 30, 09               Pricing

      Conference Only                                           (save $1000)         (save $800)      (save $600)           (save $400)             (save $200)
                                                                   $1,499               $1,799           $1,999                $2,199                  $2,399                 $2,599
      Conference + 1 Workshop                                   (save $1100)         (save $800)      (save $600)           (save $400)             (save $200)
                                                                   $2,048               $2,348           $2,548                $2,748                  $2,948                 $3,148
      Conference + 2 Workshops                                  (save $1100)         (save $800)      (save $600)           (save $400)             (save $200)
                                                                   $2,597               $2,897           $3,097                $3,297                  $3,497                 $3,697
      Conference + 3 Workshops                                  (save $1200)         (save $900)      (save $700)           (save $500)             (save $300)            (save $100)
                                                                   $3,046               $3,346           $3,546                $3,746                  $3,946                 $4,146
      Conference + 4 Workshops                                  (save $1300)         (save $1000)     (save $800)           (save $600)             (save $400)            (save $200)
                                                                   $3,495               $3,795           $3,995                $4,195                  $4,395                 $4,595
      Workshops Only                                                $549 each         $549 each        $549 each             $549 each               $549 each              $549 each
      Training Class                                                  $799              $799             $799                   $799                    $799                   $799
      All-Access Pass: Attend the 2-Day Main Conference,
      all 4 Pre-Conference Workshops, and the Training
      Class *Please specify which workshops you will            (save $3,095)                        (save $1,995)                                                         (save $999)
      attend when registering                                      $2,499                               $3,599                                                                $4,595
      Green Packaging Main Conference Add-on: Add this
      upon registration and attend both main conferences
      *Please note the add-on is for main conference only.            $749              $749             $749                   $749                    $749                   $749
      See www.iqpc.com/us/green for more information

     Prices are in Canadian currency and are subject to a 5% GST.



                                                                                                      Sponsorship and Exhibition
5 EASY WAYS TO REGISTER:
                                                                                                      Opportunities
      Web:         www.coldchainpharm.com
1
2     Call:        1-646-253-5524                                                                      Sponsorships and Exhibits are excellent opportunities for your
                                                                                                       company to showcase its products and services to high-level,
3     Email:       Mack.mendoza@iqpc.com                                                               targeted decision makers attending the conference. Pharma IQ
                                                                                                       and the 7th Cold Chain Management and Temperature Control
4     Fax:         1-646-378-6025
                                                                                                       Summit will help companies like yours achieve sales, marketing and
5
      Mail:        IQPC                                                                                branding objectives by setting aside a limited number of event
                                                                                                       sponsorships and exhibit spaces – all of which are custom-tailored
                   535 5th Avenue, 8th Floor, New York, NY 10017
                                                                                                       to help your company create a platform to maximize its exposure at
                                                                                                       the event.
     Venue and Accomodations:                                                                          For more information on Sponsoring and Exhibiting at the 7th Cold
                                                                                                       Chain Management and Temperature Control Summit, please
     Four Seasons Hotel Toronto                                                                        contact Mack Mendoza at 1-646-253-5524 or
     21 Avenue Road, Toronto, Ontario, Canada M5R 2G1                                                  Mack.mendoza@iqpc.com.
     Telephone: 1 (416) 964-0411 • Website: www.fourseasons.com/toronto

     IQPC has a reduced-rate room block for participants of Cold Chain                                 Payment Terms:
     Management & Temperature Control Summit at the Four Seasons Hotel Toronto.                        Please note that multiple discounts cannot be combined.
     For room reservations, please call the hotel directly at 416-964-0411. Be sure to                 A $99 processing charge will be assessed to all registrations not accompanied by credit
     mention that you are attending IQPC’s Cold Chain event for the group rate                         card payment at the time of registration.
     when making your reservations.                                                                    MAKE CHECKS PAYABLE IN CANADIAN DOLLARS TO: IQPC
                                                                                                       * Prices are in Canadian currency and are subject to a 5% GST.
                                                                                                       TEAM DISCOUNTS:
                                                                                                       For information on team discounts, please contact IQPC Customer Service at
     About the organizer:                                                                              1-646-253-5524. Only one discount may be applied per registrant.
                                                                                                       Details for making payment via EFT or wire transfer:
                             Pharma IQ, the pharmaceutical division of IQPC,                           JPMorgan Chase – Penton Learning Systems LLC dba IQPC: 957-097239 –
                             provides a forum to address the critical issues facing the                ABA/Routing #:021000021
                             pharmaceutical industry today. Pharma IQ utilizes                         Reference: Please include the name of the attendee(s) and the event number: 11165.003
                             workshop, conference and training course formats to                       Payment Policy: Payment is due in full at the time of registration and includes lunches,
     facilitate a learning environment for pharmaceutical professional working in all                  refreshments and detailed conference materials. Your registration will not be confirmed
                                                                                                       until payment is received and may be subject to cancellation.
     areas of drug development from Discovery to Post-Marketing.
                                                                                                       Please go online to: www.iqpc.com/cancellation to view our cancellation policy
                                                                                                       Scholarships Available: IQPC sets aside a limited number of discounts that may be
                                                                                                       applied to its conferences for delegates from the non-profit sector, government and
     Conferences and Webinars available:                                                               military organizations and academia. For more information about scholarships to this
                                                                                                       event, please call Customer Service at 1-646-253-5524.
                           Visit us at www.iqpc.com and see what other exciting                        Special Dietary Needs: If you have a dietary restriction, please contact Customer Service
                           and information-packed conferences and webinars                             at 1-800-882-8684 to discuss your specific needs.
                           being offered by the International Quality &                                ©2009 IQPC. All Rights Reserved. The format, design, content and arrangement of this
                           Productivity Center.                                                        brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable
                                                                                                       under the Lanham Act and common law principles.


    Sponsors:                                                                                                                                                                                 11
535 5th Ave, 8th Floor • New York, NY 10017



               7th Annual Cold Chain Management and
                    Temperature Control Summit
                                               Feb.23rd-26th, 2009 • Toronto, Ontario


                                        Please complete registration form & return to:
                                                   Mack Mendoza
                                                 Tel.: 646-253-5524
                                                  Fax: 212-697-4106
                                           E-mail: mack.mendoza@iqpc.com
                         Online Registration : Use Code : NAD/MM and Attn : Mack Mendoza

                                         Please register us to attend as detailed below


       Company:
        Address:
 Direct Phone:
         Email:
Delegate Name:                            Title:                                 Workshops:          Amount:
1)
2)
3)
4)
5)


                                                                                 Total:              $

Payment will be made by:


      [ ] VISA                                       [ ] AMEX                             [ ] MasterCard
Card No:                                                    Expiration Date:
Name of Cardholder:                                           Signature:
*** Any registrations not accompanied by immediate payment will be subject to a $99 service charge ***

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7th Cold Chain Management & Temperature Control Summit

  • 1. Register by Nov. 21st & save up to $3,095 7th Annual Cold Chain Management TM & Temperature Control Summit Strengthening End-to-End Cold Chain Practices to Enhance the Most Critical Steps in Distribution, Packaging and Compliance of Temperature-Sensitive Pharmaceuticals February 24 – 27, 2009 • Four Seasons Hotel Toronto • Toronto, Canada Co-located with Green Packaging – see page 10 for more details Conference Co-Chairs: Allan Reynolds Rafik H. Bishara, PhD Vice President, Industry & Member Relations Technical Advisor, Chair, Pharmaceutical Cold CANADIAN ASSOCIATION FOR PHARMACY Chain Interest Group (PCCIG) DISTRIBUTION MANAGEMENT (CAPDM) PARENTERAL DRUG ASSOCIATION (PDA) Full-day Intensive Training Class on Reengineering Your Cold Chain by Sherman Cheung, Director of Supply Chain Management, Sanofi Pasteur Hear from Canadian Pharmaceutical Attend and Learn: companies and Regulatory Agencies: The Latest Update from Health Canada on the Revisions to • Guide-0069 Abbott Laboratories Medicines and Healthcare Products Regulatory Meet Temperature Challenges during Packaging, • American Red Cross Agency (MHRA) Warehousing and Transportation Blueye, LLC Sea Star Line, LLC How to Maintain Quality in Downstream Distribution and the • Canada Border Services Talecris Biotherapeutics, Last Miles of the Cold Chain Agency (CBSA) Inc. Canadian Association of Ensuring Optimal Cold Chain Management through the • Transportation Security Chain Drug Stores (CACDS) Canadian Distribution Networks Administration (TSA) Catalent Pharma Solutions Best Practices for Cross-Border Transport and Current Global • University of Florida Franwell Inc. Regulatory Requirements US Pharmacopeia (USP) Health Canada Avoiding Excursions and Systems for Ensuring Product Quality • Johnson & Johnson RFID Systems and ePedigree Compliance Medical Products Shared • Distribution Centre Lead Sponsor: Sponsors: Badge Sponsor: www.coldchainpharm.com
  • 2. Sponsors and Media Partners Sponsors Lead Sponsor: Badge Sponsor: http://www.alternatives-tech.com http://customcritical.fedex.com Sponsors: http://www.mnthermalscience.com http://www.greenboxsystems.com http://www.kn-portal.com http://www.polyair.com http://www.temptimecorp.com http://www.envirotainer.com http://www.sensitech.com http://www.cryopak.com http://www.worldcourier.com Media Partners: “I’ve learned significant information for cold chain that I can immediately apply within my company’s operations” -QA Logistics Program Manager, Abbott Laboratories 1-800-882-8684 • www.coldchainpharm.com 2
  • 3. 7th Annual Who Will Attend: Cold Chain Management Pharmaceutical professionals in Supply Chain, Distribution, QA, TM & Temperature Control Summit Regulatory, Transportation, Packaging, and Security in the following industries: Strengthening End-to-End Cold Chain Practices to Enhance the Most Critical Steps in Distribution, Packaging and Compliance of Temperature-Sensitive Pharmaceuticals Pharmaceutical & • Medicine Manufacturing February 24-27, 2009 • Four Seasons Hotel Toronto • Toronto, Canada Bio-technology • Medical Laboratories • Dear Colleague, Transportation • Logistics, Cargo & Storage • With the overwhelming complexity of assuring product integrity through out the distribution chain, it is necessary to bring together industry regulators, end Government & Military • -users and vendors to discuss the critical issues impacting the pharmaceutical cold chain. For this reason, IQPC has brought timely, well Healthcare & Personal • thought-out programs to the pharma ceutical cold chain industry for the past seve Care Stores n years. Public Health • Building on the success of last year’s Sixth Annual event in Canada, as well as our Administration enormously successful U.S. meeting in Philadelphia each September, the Seventh Annual Canada Cold Chain Managem ent and Temperature Control Summit Medical Equipment & • will address the most urgent concerns and challenges of the North American mar Supplies Manufacturing ketplace for the distribution of temperature-sen sitive pharmaceutical products. While focusing on the always importa nt topics – how to monitor, control and maintain temperatures of bio pharmaceutical products throughout the supply chai n, from warehouse, wholesale, pharmacies Industry and hospitals to the end user – this event will also provide delegates with real life solu tions and techniques for: Breakdown: Implementing or updating an end-to-e • nd cold chain system that complies with the latest regulations, supports corporat e best practices and fits into your cost -benefit analysis Wisely choosing partners in your chai • n, including transportation, packagin g, storage and what is necessary to have in your agreement Monitoring and managing data • Complying with international regulatio • ns and understanding what is required when product crosses borders Effectively dealing with challenges inclu • ding excursions and audits ■ 56% Pharmaceutical We look forward to seeing you this & Medicine Manufacturers February in Toronto and welcoming you to IQPC’s ■ 4% Seventh Annual Cold Chain Managem Bio-Technology ent and Temperature Control Summit! ■ 4% Medical Laboratories ■ 4% Transportation ■ 4% Logistics, Cargo and Storage ■ 4% Government and Military ■ 3% Health and Personal Care Stores Lisa Ringlen ■ 3% Public Health Program Senior Conference Director Administration IQPC ■ 2% Medical Equipment and Supplies Manufacturing ■ 16% Other Sponsors: 3
  • 4. Benefit from attendee interaction! The following companies attended last year’s event: Abbott Laboratories Canada Form Solutions Patheon, Inc. Abbott Laboratories, Inc. GE Healthcare Patient Direct Alberta Health and Wellness Genzyme Canada Pfizer Canada, Inc. Allergan, Inc. GlaxoSmithKline Pharmaceutical Partners of Canada Almac Clinical Services Health Canada PharmEng Technology, Inc. Almac Group Hoffmann-La Roche Limited Polyair Alternatives Technology Pharma Hospira Public Health Agency of Canada Amerisource Bergen Information Mediary Corporation Quikx Transportation, Inc. Baxter Corporation International Safe Transit Association Roche Diagnostics BCCDC Johnson & Johnson Centocor Safety Express - Toronto Biomerieux Canada, Inc. Johnson & Johnson GPSG Sanofi Aventis Bristol Meyers Squibb Johnson & Johnson Medical, Inc. Sanofi Pasteur Calea Ltd. Materials Management & Distribution Sanofi Pasteur Canada Canadian Association for Pharmacy Distribution McKesson Canada Schering Plough Management McKesson Logistics Solutions Sensitech Canadian Blood Services Merck & Co. Shire Pharmaceuticals Cangene Corporation Merck Frosst Canada SNC Lavalin Pharma Central Medical Equiptment Depot Meyers TCP Reliable, Inc. Ciba Vision MHRA Thermal & Protective Packaging, Inc. Ciba Vision Canada, Inc. Michigan State University ThermoSafe Brands City Wide Packaging Solutions, Inc. Ministry of Health & Long-Term Care Transition Therapeutics, Inc. Department of National Defense Minnesota Thermal Science US Customs and Border Protection Defense Logistics Agency (DLA) Novo Nordisk Canada, Inc. Watson Pharmaceuticals, Inc. Dynamex Canada Corp Novopharm World Health Organization EMD Serono Canada, Inc. Oncothyreon Wyeth Laboratories Entropy Solutions, Inc. Ontario Ministry of Health Wyeth Pharmaceuticals Envirotainer Pre-Conference Training Class Tuesday, February 24, 2009 Registration for Training Class & Coffee Session 3: The Distribution Itinerary 7:15 • Why itinerary is critical to cold chain performance • Itinerary Design Criteria 8:00 am – 4:45 pm • The Transportation Mode • The Carriers REVIEW, REDESIGN AND REENGINEERING OF • Routing COLD CHAIN MANAGEMENT Special Case Study Guest: A Representative of KUEHNE + NAGEL LTD. Workshop Leader: Sherman Cheung, Director of Supply Chain Management, SANOFI PASTEUR Lunch 12:00 Session 1: Seven Deadly Myths - The Right and Wrong of Session 4: The Temperature Monitoring and Tracking Cold Chain Management • Why monitor and track temperature during transportation • Some very critical “Myths” inappropriate traditional • Types of monitoring available in the market approaches and concepts that seriously affect the • Types of monitoring that should be used in different performance Cold Chain Transportation shipment modes • The Wrong and Right approaches • How to operate different types of monitors • How to interpret the temperature during the shipment • Cold Chain deviation and product loss Session 2: The Transporters – with an Extensive Examination of Airline Carrier Capabilities and Session 5: The Re-engineering of Cold Chain Management Compliance Abilities • Logistics role in Cold Chain management • Your own Logistics Personnel • Cold Chain performance is not guaranteed • Freight Forwarder – Value-added or Road Block process • Challenges we are facing • Carriers • Partnership – why and how? • Airlines – comparing, contrasting and evaluating our options • Training and Education needed for your internal staff and • On the road external partnerships • Courier Special Case Study Guest: End of Training Class 4:45 A Representative of AIR FRANCE 1-800-882-8684 • www.coldchainpharm.com 4
  • 5. Pre-Conference Workshops Wednesday, February 25, 2009 8:00 am – 11:00 am 7:15 am Registration for Workshop A (Coffee will be served) A NEW TECHNOLOGIES TO MEET TEMPERATURE CHALLENGES DURING WAREHOUSING AND TRANSPORTATION In North America, warehousing and transportation of Drug Products traceability of products to meet new regulations such as ePedigree is are now regulated by guidelines and standards such as Health at our door. In this presentation, we explore the latest available Canada’s HPFBI Guide-0069, Parenteral Drug Association’s Technical solutions for a safe, efficient and traceable supply chain, and how to Guide 039, United States Pharmacopeia’s Chapter <1079>, ensure the implementation of the proper technologies. This International Safe Transit Association (ISTA) Test Procedures 5B and comprises monitoring and track & trace solutions such as, time- 7D, American Society for Testing and Material (ASTM) Standard Test temperature indicators, data loggers, sensor technologies (RF, RFID, Method D 3103-99, ePedigree and other regulations. conventional and others), and various models of insulated shippers and refrigerants. It becomes increasingly crucial to use the right technologies in order to maintain product temperature/humidity during warehousing and Presented By: transportation and to monitor and control the cargo temperature Jean Bédard, Chief Executive Officer, ALTERNATIVES variances in flight and on the road. The need for enabling TECHNOLOGIE PHARMA 11:15 pm – 2:15 pm 11:00 am Registration for Workshop B (Box Lunch will be served) B TEMPERATURE & TRANSPORTATION: HOW TO MAINTAIN QUALITY IN THE COLD CHAIN The transportation of temperature-controlled product How concepts of validation can be applied to enhance the • • Best practices that support the pharmaceutical industry’s regulatory consistency and quality of cold chain transportation • compliance requirements, including: Case studies of truck validation and air transportation • • The benefits of custodial control: How to avoid problems with environments. multiple handlers and protect Pedigree during transport • Relative strengths and weaknesses of various approaches at • How to gain complete visibility of temperature conditions during common temperature ranges: 2-8° C, deep frozen and and after the shipment controlled room temperature. • Contingency plans: designing transport systems to enable effective, preventative intervention Presented By: Transportation carrier quality systems: What you should expect Karl Kussow, Quality & Validation Manager, • from your carrier FEDEX CUSTOM CRITICAL 2:30 pm – 5:00 pm 2:15 pm Registration for Workshop C C MEETING TRANSPORT SERVICE PROVIDER OBLIGATIONS FOR MANAGING TEMPERATURE SENSITIVE SHIPMENTS This workshop reviews the latest changes to industry guidance and Training • the implication for transport service providers. Meeting the industry’s Facilities and equipment • requirements for an effective quality management system is • Corrective and preventative actions (CAPA) discussed in detail with a case study of an approach taken by a • Audit program platform provider to ensure effective management of their solution. Case study: Vendor driven training and quality accreditation • • Review of current industry guidance (PDA Technical Report #39 / program (QEP) Health Canada 0069 / IATA Perishable Cargo Manual) • Developing a Quality Management System Presented By: • Personnel Christopher Fore, Technical Support Manager, ENVIROTAINER, INC • Processes and procedures 5:15 pm – 8:15 pm 5:00 pm Registration for Workshop D (Dinner will be served) D COMPLETE TEMPERATURE-CONTROLLED PACKAGING SOLUTIONS FROM NEEDS ASSESSMENT TO PACKAGE QUALIFICATION This comprehensive workshop is tailored for people responsible for What You Will Learn: cold chain package design and shipping of pharmaceuticals. It will • Walk away better prepared to define scope, schedule and cost of include detailed steps required for success in selecting and designing your cold chain project temperature controlled shipping solutions. Participants will gain a • Attain knowledge of design choices of refrigerants, insulation and precise understanding of the most thorough and effective approach their interaction to the critical details related to packaging from design, testing and • Gain an understanding of the elements and advantages of well through to qualification. defined test protocol • Obtain a clear concept of the package testing and qualification How You Will Benefit: process • Elements required to define the project • New materials available to reduce packaging and their tradeoffs Presented By: • Methods to establish temperature profiles Anthony Alleva, Project Engineer, TCP/CRYOPAK • Understanding the options and issues for CRT, refrigerated, and Mike Paterno, Project Manager, TCP/CRYOPAK frozen shipments and relating them to the Canadian market Pre-Conference Workshops conclude 8:15 pm Sponsors: 5
  • 6. Main Conference Day One Thursday, February 26, 2009 Registration & Coffee 11:00 am PANEL DISCUSSION: 7:30 am DOWNSTREAM DISTRIBUTION AND THE LAST MILES OF THE COLD CHAIN Welcome from IQPC 8:15 am Provincial Government Level and the last mile, what’s going • on below the federal level? Retail Pharmacies: What procedures are you using? • Opening Remarks from the Chairperson 8:30 am How can the manufacturer monitor the product at the • individual pharmacy, wholesaler, physician, hospital, long- Day One Chair: term care facility, community health center, etc.? Allan Reynolds Maintaining procedures in rural areas Vice President, Industry & Member Relations • CANADIAN ASSOCIATION FOR PHARMACY DISTRIBUTION Panelists: MANAGEMENT (CAPDM) Heather Tyrrell Director, Membership & Trade Issues CANADIAN ASSOCIATION OF CHAIN DRUG STORES OPENING KEYNOTE: UPDATE ON GUIDE-0069 8:45 am (CACDS) Sarah Skuce Ted Prusik Compliance Specialist Senior Vice President HEALTH CANADA TEMPTIME CORPORATION Morning Networking Break 9:15 am Arminda Montero QA Logistics Program Manager ABBOTT LABORATORIES, INC. 10:00 am PANEL DISCUSSION: REGULATORY AGENCIES UPDATE With so many rules, regulations and guidelines to consider, 12:00 pm Networking Lunch how do you choose the best plan for your organization for maintaining compliance? This discussion provides a one-stop CASE STUDY PRESENTATION: place for all the latest on regulations and where you need to 1:30 pm STORAGE AND DISTRIBUTION OF DRUG be now and in the foreseeable future. PRODUCTS: ENSURING OPTIMAL COLD CHAIN • What is going on with revisions to current GMPs? Update on MANAGEMENT THROUGH THE CANADIAN GUIDE-0069, USP 1079 DISTRIBUTION NETWORKS • New regulations on storage, handling and distribution of drug samples & mail-order drugs In this presentation, Alternatives Technologie Pharma presents • What is expected by regulatory agencies? the Cold Chain Compliance program that was applied • What is next on the regulatory horizon? progressively, globally and site by site, to increase the level of compliance of the five biggest wholesalers in Canada including Moderator: 35 distribution centers across the country. The implementation Allan Reynolds of such a Cold Chain Compliance program enabled these five Vice President, Industry & Member Relations major Canadian pharmaceutical wholesalers to upgrade their CANADIAN ASSOCIATION FOR PHARMACY DISTRIBUTION cold chain management and to fully comply with the various MANAGEMENT (CAPDM) guidelines for temperature control of drug products during storage and transportation. Panelists: Sarah Skuce Presenter: Compliance Specialist Jean Bédard HEALTH CANADA Chief Executive Officer ALTERNATIVES TECHNOLOGIE PHARMA Mary G. Foster Packaging and Storage Expert Committee Member US PHARMACOPEIA “Very knowledgeable speakers. Very relevant for distribution” - Director, Distribution Operations, Pfizer Canada Inc. 1-800-882-8684 • www.coldchainpharm.com 6
  • 7. Main Conference Day One ...continued PANEL DISCUSSION: APPROACH FOR DELIVERING QUALITY 2:15 pm SEA TRANSPORT OF BIOPHARMACEUTICAL PRODUCTS AND ENSURING PATIENT SAFETY PRODUCTS Industry leaders are banking cold chain data and statistically Exploring cost-effective options by sea transportation evaluating the performance of their supply chain over time • • Pros and cons of sea transportation with the specific goals of improving supply chain performance Temperature dynamics during the whole distribution chain and overall efficiency, as well as, lowering costs and • Temperature deviation when containers are quot;unpluggedquot; documenting and mitigate risks through the development of • during transfers between sea and land carriers improved Standard Operating Procedures (SOPs). New trends Potentials and benefits of a sea/air/ground integrated point toward incorporating the Quality by Design (QbD) • distribution system framework into overall Good Cold Chain Management Monitoring and new generation of sea containers Practices by monitoring and evaluating cold chain process • • How to monitor ocean container shipments of product performance characteristics scientifically to ultimately ensure (real time vs data loggers) product quality and patient safety. How to achieve temperatures colder than -20°C for both This presentation will review the concepts above and provide case • regulatory documentation requirements and for insurance study examples to demonstrate the effectiveness of such programs. claim purposes Presenters: What type of alarm devices could be incorporated into • Mark Maurice containers to alert the shippers/drivers that the air/products Senior Project Manager temperature is warming? SENSITECH COLD CHAIN VISIBILITY ADVISORS Can perfect temperature setting be achieved? • New generation of sea containers (technologies, features) • Neritan Mustafa Ocean container owners/operators perspectives on CCM • Life Sciences Program Manager • How CCM is achieved during the whole distribution? SENSITECH, INC. • What can be done during ground and sea to assure good CCM EXTENDING GXP BEYOND THE FOUR WALLS: What users should know about sea transportation 4:45 pm • GOOD COLD CHAIN MANAGEMENT operations that may compromise CCM PRACTICES ON WHEELS SOP for temperature sensitive products transported by sea • In this presentation, the speaker will discuss how a cold chain Panelists: management program evolved through the partnering and Jean Vezina collaboration of manufacturer and carrier, with a focus on; Chief Operating Officer • Building a relationship with a cold chain provider BLUEYE LLC • Aligning strategy with capability • Developing clear expectations and responsibilities Frank Peake • Contracts, SOP’s and Quality Agreements President & Chief Operating Officer • Defining Success SEA STAR LINE, LLC • Measuring performance through KPI’s Jean Pierre Emond • Continuous improvement Professor & Co-Director, Research Center for Food Distribution & Retailing Presenter: UNIVERSITY OF FLORIDA Jim Bacon Director of Global Demand Planning & Customer Operations TALECRIS BIOTHERAPEUTICS, INC. Afternoon Networking Break 3:15 pm 5:30 pm – 6:30 pm MANUFACTURER TO CONSUMER – DEALING 4:00 pm WITH TEMPERATURE CONTROL CHALLENGES Networking Cocktail Reception for AND REGULATIONS: QUALITY BY DESIGN (QBD) all delegates AND GOOD COLD CHAIN MANAGEMENT After a day of learning and discussions, join your PRACTICES (GCCMP) - A SCIENCE-BASED colleagues from across all disciplines to exchange ideas and network in an informal environment. Sponsors: 7
  • 8. Main Conference Day Two Friday, February 27, 2009 Registration & Coffee Morning Networking Break 8:00 am 10:00 am Opening Remarks from the Chairperson 10:45 am PANEL DISCUSSION: 8:30 am A HOLISTIC APPROACH TO GOOD COLD Day Two Chair: CHAIN FROM THE PHARMACEUTICAL Rafik H. Bishara, PhD MANUFACTURERS’ PERSPECTIVE Technical Advisor, Chair, Pharmaceutical Cold Chain Interest Which companies have successfully introduced a cold chain Group (PCCIG) program and what were the keys to cost-effective PARENTERAL DRUG ASSOCIATION (PDA) compliance? What are the pharmaceutical companies experiencing the most trouble with? What specifically do they need from vendors? PANEL DISCUSSION: • Avoiding excursions: Systems for ensuring product quality 8:45 am • What are the key factors that compromise your cold chain CROSS-BORDER TRANSPORT/OVERVIEW OF and cause temperature excursion? INTERNATIONAL MARKETS • Avoiding control gaps when product moves from one piece Pharmaceutical supply chains are global. This discussion will focus of the chain to the next: i.e., from the plane/ship to the on how to maintain/control temp of international shipments in a truck and from the truck to the warehouse cost-effective manner that meets regulatory compliance, including • How much monitoring is necessary? the keys to expanding your supply chain overseas. • Dealing with excursions: What data is needed? What are • Exploring current global regulatory requirements the remedies? How to justify/investigate excursions • Comparing and contrasting regulations, procedures and best practices: Which countries and regions have the best Panelists: practices and how can the Canadian industry adopt them? Eric Malouin • Regulatory harmonization: Overcoming inconsistent laws & Distribution & Operations Supervisor regulations ABBOTT LABORATORIES, INC. • International shipments in and out of the Canadian market, especially to/from Europe and India Silvia Castellarin • Customs procedures Logistics Systems Manager • International packaging regulations JOHNSON & JOHNSON MEDICAL PRODUCTS SHARED • Expanding your supply chain into emerging markets DISTRIBUTION CENTRE • International ground transport • Security issues involved in cross-border transport of Jim Bacon pharmaceuticals Director of Global Demand Planning & Customer Operations TALECRIS BIOTHERAPEUTICS, INC. Moderator: Rafik H. Bishara, PhD Technical Advisor, Chair, Pharmaceutical Cold Chain Interest 11:45 am OUTSOURCING GOOD COLD CHAIN Group (PCCIG) MANAGEMENT PRACTICES PARENTERAL DRUG ASSOCIATION (PDA) Cold chain regulations, pharmacopeial standards and industry • Panelists: best practices Boriana Cavicchia Storage versus distribution temperature(s) for sensitive • Manager, Systems Quality, Biomedical Services medicinal products Distribution temperature acceptance criteria for cold chain AMERICAN RED CROSS • products Mau'veen Dayrell-Johnson The outsourcing program • Senior Officer, Trade Compliance Handling, storage and transportation/distribution of • CANADA BORDER SERVICES AGENCY (CBSA) temperature sensitive medicinal products • Temperature profile development: Ambient, hot and Ian Holloway cold profiles Manager, Defective Medicines Report Centre • Packaging development: Qualification per Technical MEDICINES AND HEALTHCARE PRODUCTS REGULATORY Report 39 AGENCY (MHRA) • Important factors — Matrixing product packaging A Representative of TRANSPORTATION SECURITY — Pack-outs ADMINISTRATION (TSA) AIR CARGO SECURITY — Monitoring — Performance qualification 1-800-882-8684 • www.coldchainpharm.com 8
  • 9. Main Conference Day Two ...continued Documentation requirements ePedigree compliance — • Training Effective tracking techniques to minimize time wastage — • The outsourcing program • Determining the weak link in your supply chain • Presenter: Panelists: Rafik H. Bishara, PhD Jeff Wells President & Chief Executive Officer Technical Advisor, Chair, Pharmaceutical Cold Chain Interest FRANWELL, INC. Group (PCCIG) PARENTERAL DRUG ASSOCIATION (PDA) Thomas Reese Business Development - RFID MOTOROLA ENTERPRISE MOBILITY DIVISION 12:30 pm Networking Lunch Jean Pierre Emond Professor & Co-Director, Research Center for Food Distribution & Retailing Coffee & Dessert in the Exhibit Hall 1:30 pm UNIVERSITY OF FLORIDA PANEL DISCUSSION: SMALL GROUP/ROUNDTABLE DISCUSSIONS 2:15 pm 3:15 pm DATA MANAGEMENT SYSTEMS Sustainability in Your Cold Chain Procedures • Pharmaceutical Supply Chain Security • Good data management can improve your inventory The Role of Pharmacies in Maintaining the Cold Chain • management, making recalls more efficient and providing the means to authenticate temperature management and identify counterfeit drugs. What options are available and which will Roundtable Summaries: 4:00 pm work best for your organization? Takeaways from Each Small Group Discussion Radio-frequency identification (RFID) systems: How do they • work? Are they the best option? Closing Remarks and Program Concludes 4:15 pm Other electronic product codes: What else is available? • “Good presentations with emphasis on real-life issues and work trends” – Quality Advisor, Janssen Pharmaceuticals NV “One of the best conferences I have attended” – QA Associate Director, Johnson & Johnson quot;Excellent presentations on Supply Chain involving 3rd party transportation carriers.quot; – Materials Supervisor, Bristol Myers Squibb quot;I’m looking at all of the vendors for possible applications.quot; – Sr. Transportation Analyst, Covidien “Well prepared and communicated info on all topics discussed” -Warehouse Supervisor, Bristol Myers Squibb Sponsors: 9
  • 10. Register by 12/19/08 and SAVE $500 Green Packaging February 25-27, 2009 Toronto, Canada TM Rethinking the Sustainable Packaging Paradigm: Emphasizing Good Business Practice as the Rationale for Going Green Benefits of Attending: Learn about the real cost-saving potential of • sustainable packaging Define what it really means to be green • Learn about the newest green technology, materials and solutions • Understand the emerging world of sustainability regulations • Examine the cost of sustainability – What is the ROI of going green? • Green Packaging For more information on Green Packaging is co-located with or to download the complete brochure, visit 7th Cold www.iqpc.com/us/green Chain Management and Temperature www.iqpc.com/us/green Control Summit
  • 11. 7th Annual Cold Chain Management Registration information TM & Temperature Control Summit Pricing Book and Pay By Book and Pay By Book and Pay By Book and Pay By Book and Pay By Standard Nov. 21, 08 Dec. 5, 08 Dec. 19, 08 Jan. 9, 09 Jan. 30, 09 Pricing Conference Only (save $1000) (save $800) (save $600) (save $400) (save $200) $1,499 $1,799 $1,999 $2,199 $2,399 $2,599 Conference + 1 Workshop (save $1100) (save $800) (save $600) (save $400) (save $200) $2,048 $2,348 $2,548 $2,748 $2,948 $3,148 Conference + 2 Workshops (save $1100) (save $800) (save $600) (save $400) (save $200) $2,597 $2,897 $3,097 $3,297 $3,497 $3,697 Conference + 3 Workshops (save $1200) (save $900) (save $700) (save $500) (save $300) (save $100) $3,046 $3,346 $3,546 $3,746 $3,946 $4,146 Conference + 4 Workshops (save $1300) (save $1000) (save $800) (save $600) (save $400) (save $200) $3,495 $3,795 $3,995 $4,195 $4,395 $4,595 Workshops Only $549 each $549 each $549 each $549 each $549 each $549 each Training Class $799 $799 $799 $799 $799 $799 All-Access Pass: Attend the 2-Day Main Conference, all 4 Pre-Conference Workshops, and the Training Class *Please specify which workshops you will (save $3,095) (save $1,995) (save $999) attend when registering $2,499 $3,599 $4,595 Green Packaging Main Conference Add-on: Add this upon registration and attend both main conferences *Please note the add-on is for main conference only. $749 $749 $749 $749 $749 $749 See www.iqpc.com/us/green for more information Prices are in Canadian currency and are subject to a 5% GST. Sponsorship and Exhibition 5 EASY WAYS TO REGISTER: Opportunities Web: www.coldchainpharm.com 1 2 Call: 1-646-253-5524 Sponsorships and Exhibits are excellent opportunities for your company to showcase its products and services to high-level, 3 Email: Mack.mendoza@iqpc.com targeted decision makers attending the conference. Pharma IQ and the 7th Cold Chain Management and Temperature Control 4 Fax: 1-646-378-6025 Summit will help companies like yours achieve sales, marketing and 5 Mail: IQPC branding objectives by setting aside a limited number of event sponsorships and exhibit spaces – all of which are custom-tailored 535 5th Avenue, 8th Floor, New York, NY 10017 to help your company create a platform to maximize its exposure at the event. Venue and Accomodations: For more information on Sponsoring and Exhibiting at the 7th Cold Chain Management and Temperature Control Summit, please Four Seasons Hotel Toronto contact Mack Mendoza at 1-646-253-5524 or 21 Avenue Road, Toronto, Ontario, Canada M5R 2G1 Mack.mendoza@iqpc.com. Telephone: 1 (416) 964-0411 • Website: www.fourseasons.com/toronto IQPC has a reduced-rate room block for participants of Cold Chain Payment Terms: Management & Temperature Control Summit at the Four Seasons Hotel Toronto. Please note that multiple discounts cannot be combined. For room reservations, please call the hotel directly at 416-964-0411. Be sure to A $99 processing charge will be assessed to all registrations not accompanied by credit mention that you are attending IQPC’s Cold Chain event for the group rate card payment at the time of registration. when making your reservations. MAKE CHECKS PAYABLE IN CANADIAN DOLLARS TO: IQPC * Prices are in Canadian currency and are subject to a 5% GST. TEAM DISCOUNTS: For information on team discounts, please contact IQPC Customer Service at About the organizer: 1-646-253-5524. Only one discount may be applied per registrant. Details for making payment via EFT or wire transfer: Pharma IQ, the pharmaceutical division of IQPC, JPMorgan Chase – Penton Learning Systems LLC dba IQPC: 957-097239 – provides a forum to address the critical issues facing the ABA/Routing #:021000021 pharmaceutical industry today. Pharma IQ utilizes Reference: Please include the name of the attendee(s) and the event number: 11165.003 workshop, conference and training course formats to Payment Policy: Payment is due in full at the time of registration and includes lunches, facilitate a learning environment for pharmaceutical professional working in all refreshments and detailed conference materials. Your registration will not be confirmed until payment is received and may be subject to cancellation. areas of drug development from Discovery to Post-Marketing. Please go online to: www.iqpc.com/cancellation to view our cancellation policy Scholarships Available: IQPC sets aside a limited number of discounts that may be applied to its conferences for delegates from the non-profit sector, government and Conferences and Webinars available: military organizations and academia. For more information about scholarships to this event, please call Customer Service at 1-646-253-5524. Visit us at www.iqpc.com and see what other exciting Special Dietary Needs: If you have a dietary restriction, please contact Customer Service and information-packed conferences and webinars at 1-800-882-8684 to discuss your specific needs. being offered by the International Quality & ©2009 IQPC. All Rights Reserved. The format, design, content and arrangement of this Productivity Center. brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable under the Lanham Act and common law principles. Sponsors: 11
  • 12. 535 5th Ave, 8th Floor • New York, NY 10017 7th Annual Cold Chain Management and Temperature Control Summit Feb.23rd-26th, 2009 • Toronto, Ontario Please complete registration form & return to: Mack Mendoza Tel.: 646-253-5524 Fax: 212-697-4106 E-mail: mack.mendoza@iqpc.com Online Registration : Use Code : NAD/MM and Attn : Mack Mendoza Please register us to attend as detailed below Company: Address: Direct Phone: Email: Delegate Name: Title: Workshops: Amount: 1) 2) 3) 4) 5) Total: $ Payment will be made by: [ ] VISA [ ] AMEX [ ] MasterCard Card No: Expiration Date: Name of Cardholder: Signature: *** Any registrations not accompanied by immediate payment will be subject to a $99 service charge ***