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8th Cold Chain Management & Temperature Control Summit

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Pharma IQ’s 8th Cold Chain Management & Temperature Control Summit provides the largest and most comprehensive forum for Canadian pharmaceutical, biotech and medical device professionals involved in …

Pharma IQ’s 8th Cold Chain Management & Temperature Control Summit provides the largest and most comprehensive forum for Canadian pharmaceutical, biotech and medical device professionals involved in the temperature-controlled supply chain. Attendees are able to network with and learn from other organizations who face similar challenges in monitoring, controlling, and maintaining temperatures of products throughout the supply chain – from manufacturing, warehousing, wholesalers, pharmacies, hospitals, and ultimately to the end user.

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  • 1. The World’s Largest Global Forum of Cold Chain Specialists – Sold out in the US, Canada, Belgium, UK, Brazil, Singapore and Germany COLD CHAIN 8 MANAGEMENT & Temperature Control Summit Strengthening End-to-End Cold Chain February 23-25, 2010 Practices in Distribution, Packaging and Compliance of Temperature Sensitive Westin Harbour Castle Pharmaceuticals Toronto, ON Highlights of this program will include: Hear from Canadian Pharmaceutical, • The latest updates from Health Canada on the Revisions to Guide-0069 Biotech, Regulatory and Guidance Agencies Including: • Meeting temperature challenges during packaging, warehousing and transportation • Ensuring optimal cold chain management through the Canadian distribution Abbott Canada networks Bristol-Myers Squibb • Streamlining clearance of temperature sensitive pharmaceuticals for Canadian customs and transport Canada Border Services Agency (CBSA) • Complying with IATA Chapter 17 revised regulations and biopharma requirements for temperature sensitive products Canadian Association for Pharmacy • Understanding and implementing green cold chain recyclable packaging Distribution Management (CAPDM) practices and initiatives Falvey Cargo Underwriting Health Canada Conference Chairman IATA Time & Temperature Task Force Rafik H. Bishara Johnson & Johnson PhD, Technical Advisor, Chair, Pharmaceutical Cold Chain McKesson Canada Interest Group (PCCIG) Medicines & Healthcare Regulatory Parenteral Drug Association (PDA) Authority (MHRA) Novo Nordisk Canada Novartis Pharmaceuticals Canada Inc Sanofi-Pasteur Schering Plough Talecris Biotherapeutics US Pharmacopeia (USP) World Health Organization Sponsors: www.coldchainpharm.com
  • 2. COLD CHAIN Who Will You Meet At 8 The Conference? MANAGEMENT Pharmaceutical professionals in Supply Chain, Distribution, QA, Regulatory, Transportation, Packaging, and Security in the following industries: & Temperature Control Summit TM Pharmaceutical & Medicine Manufacturing • Bio-technology Strengthening End-to-End Cold Chain Practices in Distribution, • Medical Laboratories Packaging and Compliance of Temperature Sensitive Pharmaceuticals • Transportation • Logistics, Cargo & Storage • Government & Military Dear Colleague, • Healthcare & Personal Care Stores With the overwhelming complexi • Public Health Administration ty of assuring product integrity throu chain, it is necessary to bring toge ghout the distribution • Medical Equipment & Supplies ther industry regulators, end-users critical issues impacting the pharmac and vendors to discuss the Manufacturing eutical Cold Chain. For this reason, timely, thought-out programs to the IQPC has brought pharmaceutical cold chain industry for the past seven years. Building on the success of last year’ s event, as well as our enormously Philadelphia each September, the Eighth Annual Cold Chain Managem successful U.S. meeting in A Special Thanks To Our Control Summit will address the mos ent and Temperature Executive Advisory Board t urgent concerns and challenges marketplace for the distribution of of the North American temperature-sensitive pharmaceutic al products. While focusing on the always impo Allan Reynolds rtant topics – how to monitor, cont temperatures of bio pharmaceutic rol and maintain Vice President, Industry & Member al products throughout the supply wholesale, pharmacies and hospitals chain, from warehouse, Relations to the end-user – this event will also life solutions and techniques for: provide you with real Canadian Association for Pharmacy Distribution Management (CAPDM) • Implementing or updating an end- Rafik H. Bishara, PhD to-end cold chain system which supp practices and fit into your cost-bene ort corporate best Technical Advisor, Chair, Pharmaceutical fit analysis • Understanding current global regu Cold Chain Interest Group (PCCIG) latory requirements including com USP <1079> pliance with revised Parenteral Drug Association (PDA) • Wisely choosing partners in your chain, including transportation, pack Karl Kussow what is necessary to have in your aging, storage and agreement Manager, Quality and Validation • Monitoring and managing data • Challenging Cold Chain distributi FedEx Custom Critical on to rural and remote locations • Implementing measurable and repe Sherman Cheung atable Cold Chain logistics processes using a core team Director of Supply Chain Management approach • Effectively managing your Cold Chai Sanofi Pasteur n on a limited budget P Don miss the .S. ’t Gloria Markiewicz We look forward to seeing you this welcoming you to IQPC’s Eighth Ann February in Toronto and highly interactive and Associate Director, Supply Chain ual Cold Chain informative pre- Novo Nordisk Canada Inc Management and Temperature Con trol Summit! confer ence Kevin O’Donnell Best Regards Director & Chief Technical Advisor, workshops! See pages Tegrant Corp., ThermoSafe Brands & 5 & 6 for details. Chair IATA Time & Temperature Task Force Jim Bacon Director of Global Demand Planning & Simon Curtis Customer Operations Senior Conference Director, Phar Rafik H. Bishara ma IQ PhD, Technical Advisor, Chair, Phar Talecris Biotherapeutics, Inc. Simon.curtis@iqpc.com maceutical Cold Chain Interest Group (PCC Clifford W. Wyllie IG) Parenteral Drug Association (PDA Vice President, Bio-Pharma Healthcare ) Services Cavalier Logistics Industry Breakdown: Arminda Montero ■ 56% Pharmaceutical & Medicine ■ 3% Health and Personal Distribution QA Program Manager, Global Manufacturers Care Stores Pharmaceutical Operations ■ 4% Bio-Technology ■ 3% Public Health Program Abbott ■ 4% Medical Laboratories Administration Matty Toomb ■ 2% Medical Equipment and Vice President, Sales & Marketing ■ 4% Transportation American Thermal Instruments Supplies Manufacturing ■ 4% Logistics, Cargo and Storage Umit Kartoglu, MD, PhD ■ 16% Other ■ 4% Government and Military Scientist World Health Organization (WHO) 2 REGISTER ONLINE AT WWW.COLDCHAINPHARM.COM OR CALL 1-800-882-8684
  • 3. CONFERENCE DAY ONE Wednesday, February 24, 2010 7:30 Registration and Coffee • Packaging development: Qualification per Technical • Effective tracking techniques to minimize time wastage • Determining the weak link in your supply chain 8:30 Welcome Address and Chairperson’s Opening Remarks Rafik H. Bishara, PhD, Technical Advisor, Chair, Pharmaceutical Cold Chain Eric A. Newman, Vice President, Loss Prevention, Protecht Risk Solutions, Falvey Interest Group (PCCIG), Parenteral Drug Association (PDA) Cargo Underwriting Canadian and International Regulatory Compliance Updates 2:15 Seven Deadly Myths - The Rights and Wrongs on Cold Chain Distribution Management 8:45 Complying with Health Canada Guidelines for • Understanding some common misunderstandings, assumptions, traditions and Temperature Control during Storage and Transportation - beliefs in Cold Chain distribution GUI-0069 (Version 2) • Challenging the traditions and wrong assumptions • Overview of the revised GUI-0069 and GMPs related to temperature control • Fundamentally re-thinking /re-designing the Cold Chain distribution practice/process • Discussing the new requirements in the 2009 revision of GUI-0069 • Examining future directions for core processes within your cold chain • Understanding requirements for wholesaling, storage and shipping Sherman Cheung, Director of Supply Chain Management, Sanofi Pasteur • Packaging, labeling, documentation, and record keeping requirements • Sample observations and corrective action expectations 3:00 Afternoon Networking Break • Common questions from Industry on the topic of GUI-0069 Sarah Skuce, Compliance Specialist, Health Canada Addressing Customs and Transportation Concerns 9:30 Complying and Applying USP <1079> “Good Storage and 3:45 Panel Discussion: Best Practices for Streamlining Clearance of Shipping Practices” Temperature Sensitive Pharmaceuticals for Canadian Customs • Understanding the role of the USP within the industry and the latest information and Transport regarding standards • Understanding some common misunderstandings, assumptions, traditions and • Outlining the new 1079 chapters for implementation beliefs in cold-chain distribution • Understanding 1079’s definition for validation (for packaging) and comparing to • Challenging the traditions and wrong assumptions other industry standard guidelines • Re-thinking/re-designing cold-chain distribution practice/process • Packaging, storage and distribution • Identifying strategies for overcoming shipping impediments and inefficiencies at • Container processes and requirements Canadian/US boarder crossings • Overview of evidence gathered • Understanding what is in store for future overland Canadian border crossing • Uncovering new guidelines cold chain operations Mary Foster, PhD, USP Packaging and Storage Expert Committee Member, US Moderator: Pharmacopeia (USP) Rafik H. Bishara, PhD, Technical Advisor, Chair, Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA) 10:15 Morning Networking Break Panelists: Mau'veen Dayrell-Johnson, Senior Officer, Trade Compliance, Canada Border 11:00 European Regulatory Guidelines: Controlled or Ambient Services Agency (CBSA) Temperatures, Stability Data and Compliance Invited: A Representative of US Customs and Border Protection (CBP), • Expectations and documenting for ambient or CRT products Department of Homeland Security • Regulatory expectations for qualification or validation • Stability studies versus shipping studies – Are stability studies enough to set the limits for your cold chain? 4:30 Interactive Global Distribution and Storage Strategies Roundtable Discussions Ian Holloway, Manager, Defective Medicines Report Centre, Medicines and After a full day of presentations, it’s time for all participants to take an active role Healthcare Products Regulatory Agency (MHRA) and get answers to specific questions. These informal discussions will provide an opportunity to exchange ideas related specifically to job functions and interests. 11:45 Panel Discussion: Understanding Current and Future Facilitators will present a short case study as an introduction to these 45 minute Regulatory Expectations for Cold Chain both Domestically discussion and question sessions. Round Table Discussions include: and Internationally • Global regulatory approach to temperature compliance for cold chain and • Lessons learned in justifying Pharma company actions and validation plans to temperate products regulators – What exactly demonstrates control? • Implementing a validation lifecycle program for shipping temperature control • New regulations on storage, handling and distribution of drug samples & mail- pharmaceuticals order drugs • Developing new shipping and validation processes for strict 2-8° biopharm products • Extrapolating future regulatory requirements in-line with cold chain trends • Best practices for data management associated with distribution of • Discussing global regulatory concerns and impending international changes temperature-sensitive clinical trial materials • PCCIG ‘Last Mile’ guidance document: implementing processes and standards Moderator: to ensure temperature control to the patient Rafik H. Bishara, PhD, Technical Advisor, Chair, Pharmaceutical Cold, Chain Interest Group (PCCIG), Parenteral Drug Association (PDA) Strengthening Cold Chain Vendor Relations Panelists: Sarah Skuce, Compliance Specialist, Health Canada 5:15 Effective Management of Third Party Relationships Mary Foster, PhD, USP Packaging and Storage Expert Committee Member, US • Conducting needs assessment – With stake holder engagement Pharmacopeia (USP) • Alignment of requirements with service offering • Using a team approach for criteria of vendor selection and ranking Ian Holloway, Manager, Defective Medicines Report Centre, Medicines and • Validating and assessing various decision criteria Healthcare Products Regulatory Agency (MHRA) • Maximizing the Relationship • Using KPIs for targets and rating of performance 12:30 Networking Luncheon • Discussing continuous improvement initiatives Effectively Cold Chain Management & Risk Mitigation Gloria Markiewicz, Associate Director, Supply Chain, Novo Nordisk Canada Inc 1:30 Outsourcing Good Cold Chain Management Practices for 6:00 Chairperson’s Closing Remarks and End of Day One Optimizing Risk Mitigation • Cold chain regulations, pharmacopeial standards and industry best practices 6:15 – 7:15 • Storage versus distribution temperature(s) for sensitive medicinal products Networking Cocktail Reception for all delegates • Distribution temperature acceptance criteria for cold chain products After a day of learning and discussions, join your colleagues from across all • Handling, storage and transportation/distribution of temperature sensitive disciplines to exchange ideas and network in an informal environment in the medicinal products exhibition hall. • Temperature profile development: Ambient, hot and cold profiles 3 Sponsors:
  • 4. CONFERENCE DAY TWO Thursday, February 25, 2010 8:00 Registration and Coffee • Encouraging participation at receiving locations, by providing display posters to those requesting them • Introducing a “Green Solutions” Recycling Program to promote the return 8:30 Welcome Address and Chairperson’s Opening Remarks of all time/temperature data collection instruments for recycling Rafik H. Bishara, PhD, Technical Advisor, Chair, Pharmaceutical Cold Chain Mary Kolodij, Director of North American Operations, Schering Plough Interest Group (PCCIG), Parenteral Drug Association (PDA) Duane Eckelman, Manager of North American Logistics, Schering Plough Transportation and Logistics 2:15 Panel Discussion: Understanding and Implementing Green 8:45 Comparing Cost and Packaging Strategies for Air and Cold Chain Recyclable Packaging Practices and Initiatives Ground Shipping for Your Cold Chain • Addressing the need to create sustainable products that protect • Knowing the storage characteristics of the product and the most temperature sensitive goods • Maximizing the use of renewable or recycled source materials appropriate temperature regime • Displaying a drug manufacturer’s perspective: How safe, efficient, cost • Determining the appropriate temperature by small-scale storage trials effective and green are the solutions on the market? • When transporting by air, there is very little availability of even limited • Discussing lean initiatives, internal recycling programs, energy conservation, temperature control reusable solutions, and recyclable products • Addressing packaging-related issues with freight transfers from air to ground • Identifying green packaging solutions for a variety of cold chain shipment • Validating packaging requirements with shipment size, risk mitigation and sizes and irregular goods cost comparisons • Matching the right shipment to the right recyclable Eric Malouin, Ing, Distribution and Operations Supervisor, Abbott Canada Moderator: Maurice Barakat, President & CEO, TCP Reliable 9:30 Panel Discussion: Complying with IATA Chapter 17 Revised Panelists: Regulations and Biopharma Requirements for Temperature Gloria Markiewicz, Associate Director, Supply Chain, Novo Nordisk Canada Inc Sensitive Products • Quality Management Systems requirements (including exception management) Carolyn Williamson, PhD, Validation Scientist, Bristol Myers Squibb • Understanding processes and responsibilities of the shipper, forwarder, ground handlers/transportation service provider, consignee, and air carrier 3:00 Afternoon Networking Break processes and responsibilities • Storage and warehousing requirements (including temperature mapping) Last Mile Cold Chain Logistics • Introduction of new Time & Temperature sensitive handling label usage requirements 3:30 Challenging the Cold Chain with Distribution to Rural and Kevin O’Donnell, Director & Chief Technical Advisor, Tegrant Corp., Remote Locations ThermoSafe Brands & Chair, IATA Time & Temperature Task Force • Confronting distribution challenges for vaccines transported to rural and remote locations • Obtaining operational efficiency with the use of monitoring systems to track 10:15 Morning Networking Break shipments • Harmonizing guidance for storage and transport of temperature-sensitive 11:00 Implementing Measurable and Repeatable Cold Chain pharmaceutical products Logistics Processes Using a Core Team Approach • Consolidate regulations and guidance on the storage and transport of • Reviewing how a disciplined process proactively measures provider temperature-sensitive pharmaceutical products from a wide range of performance, and through change, creates confidence in desired outcomes. international sources into a single, relatively short document • Defining the post-shipment analysis process: Shipping Summary Report and • Developing an international guide to good practice in this field, whilst Transport Evaluation accepting that local legislation and regulations will continue as precedence • Working with a Core Team approach to establish Transport Evaluation Criteria • Leveraging end-user participation through training and communication • Putting our process to the test: Measuring provider performance - What can Umit Kartoglu, MD, PhD, Scientist, World Health Organization (WHO) we do with the data? • Leveraging this information with providers to identify, change, strengthen or 4:15 Panel Discussion: Addressing Canadian Regulatory eliminate the weak link Frameworks from Manufacturer-To-Pharmacy • Using continuous improvement to create a sustainable process Ensuring end-to-end temperature and product stability throughout the entire Jim Bacon, Senior Director, Global Demand Planning & Customer Operations, cold chain requires collaborative relationships, compliance at every stage, and Talecris Biotherapeutics, Inc. responsibility to adhere to regulatory guidelines from the manufacturer to the pharmacy recipient. This regulatory panel will address country-specific standards 11:45 New Monitoring Technologies to Meet Temperature and provide case studies to inform regulatory best practices and ultimately Challenges during Warehousing and Transportation strengthen compliance of cold chain distribution throughout Canada. In this presentation, we explore the latest available monitoring solutions for a Moderator: safe and efficient supply chain, and to ensure the implementation of the right Allan Reynolds, Vice President, Industry and Member Relations, Canadian technologies. Association for Pharmacy Distribution Management (CAPDM) • Presenting the cold chain compliance and management principles, Panelists: particularly in terms of monitoring and tracking Sarah Skuce, Compliance Specialist, Health Canada • Presenting the various monitoring solutions and their technical capacities and features that can apply onto temperature control of drug products Claude Jolicoeur, Director, Regulatory Affaires, Corporate GMP Officer, during storage and transportation McKesson Canada • Presenting cold chain monitoring solutions and their implantation in typical John Collins, M.Sc, Director, Quality Assurance, Novartis Pharmaceuticals stakeholders of the Canadian supply chain (e.g. wholesalers/distributors, Canada Inc pharmacies, etc) Jean Bédard, Chief Executive Officer, Alternatives Technologie Pharma 5:00 Best Practices for Effectively Managing Your Cold Chain on a Limited Budget 12:30 Networking Luncheon • Understanding Cold Chain best practices for ship multiple product sizes efficiently • Discussing effective strategies and methods for simplifying the process without Initiating Green Cold Chain Practices threatening QA • Cutting costs on the consumerables and effective waste elimination • Understand if you are saving or making money in the long run 1:30 Setting up an Effective Recycle and Reuse Program for Your Cold Chain Hashim Ayyaril, Manager, Product Logistics, Ortho Clinical Diagnostics, • Working with environmentally-conscious partners to develop recycling Johnson & Johnson programs on an ad-hoc basis without increasing spending John Collins, M.Sc, Director, Quality Assurance, Novartis Pharmaceuticals • Encouraging pharmaceutical manufacturers and temperature sensitive Canada Inc distributers to return all formats of digital and analog time/temperature data recorders for proper recycling 5:45 Chairperson’s Closing Remarks and Close of Conference 4 REGISTER ONLINE AT WWW.COLDCHAINPHARM.COM OR CALL 1-800-882-8684
  • 5. PRE-CONFERENCE WORKSHOPS Tuesday, February 23, 2010 Choose from Workshops A or B 8:30am – 11:30am Registration at 8:00am (Coffee will be served) A Addressing Cold Chain Quality for Small Volume Shipments – An Integrated Approach Ensuring the safe transport of small-volume temperature-controlled shipments presents • Decision making factors for evaluating cost-effective transportation strategies for a unique set of challenges. In this workshop we’ll look at how a manufacturer, cold chain packaging provider and logistics company worked together to resolve challenges in How you will benefit: transporting high-value, low volume pharmaceutical products internationally. You’ll leave the workshop with some practical steps to ensure that your high-value What you will learn: and temperature sensitive shipments are delivered reliably and consistently. You will Through case studies and open discussion you’ll see how a collaboration among understand how one collaboration addressed the real-life obstacles in international shipper, packaging provider and logistics provider helped reduce product loss and transportation. simplify the logistics process for small but high-value pharmaceutical shipments. • Improve the consistency of your temperature controlled shipping results We’ll discuss the how each party addressed the elements of the logistics process for • Reduce the costs of packaging storage, disposal and transportation temperature-sensitive products. • Improve the efficiency of your logistics operations through packaging • Relative benefits and limitations of disposable vs. reusable packaging standardization and logistics quality. • How to ensure your logistics provider’s processes are robust and deliver consistent Your Workshop Leader: results John Liebe, Director of Sales, North America, LifeConEx LLC B Leveraging New Refrigerant Technologies: Use of Engineered Phase Change Materials in Cold Chain Packaging Design What you will learn: • How traditional water based refrigerants are best utilized and what are their true • Alternatives to traditional gel pack refrigerants available in the industry limitations • How to identify and evaluate the trade-offs in material costs v. the total costs of • How engineered phase materials can contribute to your company sustainability the packaging and distribution initiatives • Performance variables to consider in the selection of a PCM • Re-usability v. Single use? What types of applications are engineered PCM's best deployed? How you will benefit: • Through case studies interaction with packaging and logistics peers, you will go Your Workshop Leader: through examples to understand: Anthony Alleva, Technical Services Manager, TCP Reliable/Cryopak Choose from Workshops C or D 12:00pm – 3:00pm Registration at 11:30am (Lunch will be served) C Quality and Efficiency for Cost & Temperature Controlled Transportation The workshop will facilitate a discussion of considerations for choosing a transportation How you will benefit: method, including international regulations, shipping environments, and the strengths Through case studies of real-life examples and interactive exercises, you will and weaknesses of available temperature control options for air and ground transport. understand how transport systems can be designed to significantly reduce or The group will discuss solution options and criteria for designing best practice eliminate common problems in domestic US and international air transport. You will transportation systems and procedures that appropriately blend the needs of your gain an appreciation for the relative costs and benefits of achieving your product, your business, and available services. We will also explore the effectiveness of transportation objectives within the framework of your GDP requirements and various choices by considering case studies for both ground and air transport. discuss how to minimize those costs while maintaining safe transport requirements. • Improve your ability to implement high quality, secure, and cost-effective transportation What you will learn: • Enhance your ability to apply industry and governmental guidance on Good • Gain insight into carrier quality systems for both standard transportation and Distribution Practices in your transportation plans temperature control including: • Increase your understanding of how to effectively work with your carrier to • Strategies for implementing best practices for achieving high quality and safety in maximize the quality, consistency, and economy of your shipping lane both air and ground transport • Effective procedures to address transport risk issues Your Workshop Leader: • Decision making factors for evaluating cost-effective transportation strategies for Karl Kussow, Manager Quality & Validation, cold chain FedEx Custom Critical D Use of Advanced Predictive Simulation Technology – As Applied to Cold Chain Management The workshop will facilitate a discussion and hands on with Advanced Predictive • Solve a thermal simulation model and review 3D results to understand shipper Simulation software. The group will discuss the “As Is” process of iterative physical performance for; testing for the design and validation of cold chain shippers. The group will also discuss • Conduction solution options or possible “To Be” process improvements by utilizing Advanced • Convection (passive or active) Predictive Simulation Technology early in the design or selection phase of cold chain • Phase Change shipper configurations. • Environmental Solar Load conditions • Transient Temperature Profile Follow a self-paced hands-on tutorial that guides you through the creation process of a simulation model of a cold chain shipper. Apply thermal, flow and phase change boundary How you will benefit: condition and solve for a transient solution for a summer profile. Post process 3D result to By utilizing an integrated design & simulation environment, you will be able to; determine the performance of your design. Review conducting, convection and the • Efficient optimization of design concepts & revisions performance of the phase change materials over the ambient temperature profile selected. • Evaluate alternative distribution routing profiles • Qualify designs for specific ambient temperature profiles What you will learn: • Reduce the need for iterative physical testing Through interactive exercises, you will learn how simulation models of cold chain • Assess impact of temperature excursions during shipment packaging systems can be quickly constructed. 3D results provide a precise and in- • Meet or exceed industry quality standards depth insight into temperature distribution on all components of the packaging system; • Reduced product liability costs • Create a complex assembly consisting of shipper components, gel packs and product payload Your Workshop Leader: • Define a shipping lane or ambient temperature profile Iftekhar Ahmed, Senior Specialist, Cold Chain Management MAYA Simulation Technologies Ltd. 5 Sponsors:
  • 6. PRE-CONFERENCE WORKSHOPS continued... 3:30pm – 6:30pm Registration at 3:00pm E Performing an Efficient Cold Chain Compliance and Process Gap Analysis? The pharmaceutical cold chain concept implies all necessary means to maintain • Performing a gap analysis to know what needs to be done in order to fully comply therapeutic products in the specified manufacturer’s temperature limits during all with regulations and optimise your processes the logistic and distribution process (manufacture, storage, transportation, final How you will benefit: use). The cold chain compliance and process gap analysis is the very first step to • Understand how to execute a cold chain regulatory gap analysis evaluate the compliance of your operations and logistics in regard to the regulatory • Discover what should be covered when looking at cold chain compliance context and to the security of your products. The respect of the cold chain initially • Gap analysis: A first step to develop a cold chain compliance program. implies to know well constraints which surround it and traps to be avoided. • Uncover the requirements for the storage and distribution of drug products What you will learn: • Sharing the responsibilities for a good cold chain compliance • All regulatory aspects related to the cold chain • Responsibilities in the supply chain Your Workshop leader: • Requirements for the storage and handling of drug products Jean Bédard, Chief Executive Officer, • Packaging, transportation and distribution of drug products Alternatives Technologie Pharma ABOUT OUR SPONSORS Alternatives Technologie Pharma Inc. (“ATP”) is a privately-hold right time, and in the right condition. A global provider of end-to-end qualified Laval-based company that specializes in Cold Chain Control and transportation services worldwide, designed to protect the integrity and quality of the Management solutions for the Life Sciences and Health sectors. products posting fewer delays, less cycle time, less temperature deviations, less damage, Our mission is to offer efficient and user-friendly solutions to ensure and far fewer claims than typically experienced by shippers. LifeConEx offers regulatory the integrity of highly-sensitive products by regulatory compliance compliant process mapping, customized quality agreements, comprehensive 24/7 process services, Environmental monitoring solutions, track and trace solutions, packaging design and quality control, and technical consulting. Strategically LifeConEx looks to integrate and validation/qualification for highly-regulated industrial sectors such as the Life new practices and more efficient ways of managing temperature-sensitive products, by Sciences, Food and Transportation/Logistics industries. Our activities are integrated into providing overall value in regard to time and productivity. LifeConEx boosts various four major axes: Regulatory compliance, Environmental monitoring, Design and Test of temperature controlled supply chains with greater control, reduction of risk, and elevation Cold Chain Packaging, and Cold Chain Packaging Supplies. of ROI. Website: www.lifeconex.com Website: www.alternatives-tech.com Cryopak (a TCP Reliable Company), specializes in the field of FedEx Custom Critical offers a complete array of surface and air temperature controlled packaging and services including package solutions to safely and securely ship temperature-sensitive products. design, qualification, testing manufacturing insulated shippers, You can choose from exclusive-use vehicles with temperature refrigerants, phase change materials and temperature monitors. All services are provided controlled cargo boxes to airfreight solutions utilizing temperature-controlled air in strict conformance with ISO 9001:2000, ISTA and ASTM test methodology, and FDA containers. With our Temp-Assure Validated services, you also receive hard-copy good manufacturing practices. TCP maintains facilities in Quebec, British Columbia, New documentation of the temperature inside the vehicle or container throughout transport. Jersey and France. Website: www.cryopak.com This assists our pharmaceutical customers with their compliance needs through a documented audit trail of their products’ temperature throughout the shipping process. Skelton has provided refrigerated services for 28 years to FedEx Custom Critical services are available 24/7/365 with surface solutions throughout Pharmaceutical/Biological companies. We partner with customers to the U.S. and Canada and air solutions across the globe. ensure we maintain product integrity through out the cold chain link. Website: www.customcritical.fedex.com Our Critical Care Division validated trailers are devoted for products that require 2°C to 8°C with double reefers units to ensure the safety of the products. Minnesota Thermal Science, LLC develops unique storage and Our investment in assets, people and training have provided our customers with a Tried, shipping systems that address the challenges of maintaining constant Tested and Proven solution that meets and exceeds Health Canada 0069 regulations. and predictable temperatures when transporting temperature sensitive Website: www.skeltontruck.com medical materials. Founded in 2004 following an industry wide search by the Walter Reed Army Institute of Research for a more effective combat environment Pioneer and market leader Envirotainer offers flexible leasing container, MTS has continued to apply its technology to handle other important medical (rental) of advanced transport solutions for worldwide air cargo materials including all types of biomaterials and pharmaceuticals that require controlled shipments of temperature-sensitive products. Customers within the healthcare, life temperatures Its patent pending Golden Hour® Technology, winner of a "U.S. Army sciences, food and high-tech industries benefit from the combination of advanced Greatest Inventions" award, is credited with saving soldier's lives on the battlefield and container technology, extensive cold chain management services and a global network of with revolutionizing the methods used for distributing temperature sensitive medical service partners, airlines and forwarders - providing a unique one-way leasing service. supplies. Website: www.goldenhourtechnology.com Envirotainer secures the safety and integrity of product cold chains by providing an active temperature-control system, training all parties along the cold chain and supporting Temptime’s TransTracker is a monitoring device containing customers in transport validations and risk management. Website: www.envirotainer.com scientifically proven time-temperature indicator technology. TransTracker products identify exposure to freezing, high heat and Sensitech - The leading provider of cold chain visibility solutions that cumulative heat exposure during shipping and short-term storage. enable our customers to track and monitor assets across the supply TransTracker is easy to read, accurate and can deliver cost savings of over 50%. Temptime chain, protecting the quality, efficacy, and integrity of their temperature- is the world leader in time-temperature indicator technology. Temptime operates under a sensitive products. Our product portfolio includes comprehensive analytic quality system certified to ISO 9001:2000 and ISO 13485 standards and is compliant with services, enterprise software systems and validated data acquisition devices. We address medical device Good Manufacturing Practices. For more information contact Chris our customers’ most complex perishable cold chain problems and deliver powerful Caulfield at 973-984-6012. Website: www.temptimecorp.com insights that drive measurable process improvement. Sensitech supports cold chain monitoring programs in 18 of the top 20 multi-national pharmaceutical companies and 9 World Courier has set the benchmark for worldwide time & of the top 10 biopharmaceutical companies. Sensitech is a business unit of Carrier Corp. temperature sensitive transportation. We remain the only Website: www.sensitech.com specialist courier company with its own global company network .Each office ISO 9001 certified with the same operating standards Marken is one of the leading suppliers of cold-chain logistics for dedicated to treating every shipment on an individual, priority basis. World Courier is clinical supplies worldwide. Temperature-control during the utilized in approximately 80% of the world’s clinical trials requiring the use of a specialty handling, storage and distribution of cold-chain products is a courier. With experience in managing the logistics of over 7,500 clinical trials worldwide, critical element of the clinical trial process. Our expertise is of critical importance to we are the acknowledged experts in handling temperature-sensitive specimen and drug ensuring the safe arrival of high value shipments to sites. We provide: shipments. Website: www.worldcourier.com • Global distribution of temperature controlled trial medication, vaccines & CTM • Temperature control monitoring for ambient, 2-8C and frozen products to maintain LifeConEx is a joint venture between DHL Global Forwarding, the integrity of supplies world's largest air and ocean freight forwarder, part of Deutsche Post • Advice on packaging materials and provision of containers for global transportation World Net, and Lufthansa Cargo, the leading airfreight cargo • Refrigerated trucking services company on the international market. LifeConEx is the only industry-specific provider of • Customs brokerage accelerating clearance integrated end-to-end temperature controlled transportation solutions for the life sciences Website: www.marken.com industry ensuring that highly sensitive products are delivered at the right place, at the 6 REGISTER ONLINE AT WWW.COLDCHAINPHARM.COM OR CALL 1-800-882-8684
  • 7. Founded in 1981, American Thermal Instruments, Inc. has that are responsible for the stockpiling and rapid deployment of pharmaceutical products been exceeding customer expectations as an international for disaster and pandemic relief. We offer a unique service to healthcare providers organization specializing in temperature monitoring solutions. ATI because we can provide one-stop 3PL logistical services from the point of manufacture, in temperature monitoring solutions include liquid crystal Cavalier validated refrigerated equipment. We also have validated 5°-C, -10°-C to -40°- thermometers, irreversible temperature indicators, color changing products, Log-ic® C, -80°-C and -156°-C storage at our Washington D.C. Headquarters. Our Washington electronic content monitoring, and microencapsulation services. Our facility is ISO 9001 Headquarters is licensed by the United States Drug Enforcement Agency and the certified, FDA registered, and operates under cGMP. ATI manufactures non toxic, non- Commonwealth of Virginia Board of Pharmacy to house and distribute schedule 2-6 breakable, reusable, disposable and easy-to-read thermometers for diverse markets and pharmaceutical products. We provide seamless third party logistical services for high value applications. ATI acts as a distribution arm for the Log-ic® Temperature Tracking System. vaccines, clinical trial samples, specimens, reagents and a multitude of products that The Log-ic® system is revolutionizing the Cold Chain, giving customers the capability to require expert handling. Website: www.cavlog.com track and trace temperature history of shipments. Website: www.americanthermal.com MAYA Simulation Technologies Ltd. is a developer of thermal and ATS Healthcare Solutions offers a broad range of flow simulation software tools. MAYA's simulation solutions provide transportation services including temperature management comprehensive and accurate insight into the thermal behavior of a offerings specifically designed to meet the requirements of wide range of cold chain transport systems reducing the need for Health Canada guideline 0069. ATS is focused on providing solutions within Canada for prototype testing. MAYA offers a complete software simulation solution for the thermal the healthcare industry and as such operates a network of branches coast to coast and a design and optimization of cold chain transport systems. MAYA's thermal simulation fleet of temperature controlled vehicles. Website: www.ats.ca solution can model all aspects of heat transfer including conduction, convection and radiation. The thermal and flow solvers are fully capable of modeling steady state as well Cavalier Logistics is dedicated to providing “Turn-Key Cold as transient thermal/flow conditions. Additionally we incorporate advanced tools such as Chain Solutions” for business in the Life and Analytical Sciences, phase change materials, condensation/humidity calculations, dust/smoke distribution Pharmaceutical Manufacturing, Diagnostic Kit Manufacturing, tracking etc. Website: www.mayahtt.com Vaccine and Healthcare Providers. In addition, we provide service government agencies REGISTRATION INFORMATION Register By Register By Standard January 8, 2010 January 29, 2010 Price Conference Only $1,599 (save $600) $1,799 (save $400) $2,199 All Access Includes 3 pre-conference workshops and the main conference. $2,399 (save $1,447) $2,599 (save $1,247) $2,999 (save $847) Workshops $549 each $549 each $549 each SPONSORSHIP AND Venue & Accommodations: EXHIBITION OPPORTUNITIES IQPC has a reduced-rate room block for participants of the Cold Chain Management & Temperature Control Sponsorships and exhibits are excellent Summit at the Westin Harbour Castle. The group rate is opportunities for your company to showcase available for 3 days pre- and post-conference, based on its products and services to high-level, availability. Please contact the hotel directly at (416) 869- Westin Harbour Castle 1600 before January 25, 2010. Be sure to mention you targeted decision-makers attending the 8th One Harbour Square are attending IQPC’s Cold Chain Management Summit for Cold Chain Management & Temperature Toronto, Ontario M5J 1A6 the group rate when making your reservation. Control Summit. IQPC and Pharma IQ help Phone: (416) 869-1600 companies like yours achieve important sales, marketing and branding objectives by Prices are in Canadian currency and are subject to a 5% GST. Reference: Please include the name of the attendee(s) setting aside a limited number of event Please note multiple discounts cannot be combined. and the event number: 11165.004 sponsorships and exhibit spaces – all of A $99 processing charge will be assessed to all registrations not Payment Policy: Payment is due in full at the time of which are tailored to assist your organization accompanied by credit card payment at the time of registration. registration and includes lunches and refreshment. Your registration will not be confirmed until payment in creating a platform to maximize its MAKE CHECKS PAYABLE IN CANADIAN DOLLARS TO: IQPC is received and may be subject to cancellation. Prices are in Canadian currency and are subject to a 5% GST. exposure at the event. For IQPC’s Cancellation, Postponement and Team Discounts: For information on team discounts, please contact IQPC Substitution Policy, please visit Customer Service at 1-800-882-8684. Only one discount may be applied per www.iqpc.com/cancellation For more information on sponsoring or registrant. Special Dietary Needs: If you have a dietary restriction, exhibiting at the 8th Cold Chain Special Discounts Available: A limited number of discounts are available please contact Customer Service at 1-800-882-8684 for the non-profit sector, government organizations and academia. For more to discuss your specific needs. Management & Temperature Control information, please contact customer service at 1-800-882-8684. Summit, please contact Mario Matulich at ©2009 IQPC. All Rights Reserved. The format, design, Details for making payment via EFT or wire transfer: content and arrangement of this brochure constitute a 212-885-2719 or sponsorship@iqpc.com. JPMorgan Chase - Penton Learning Systems LLC dba trademark of IQPC. Unauthorized reproduction will be IQPC: 957-097239 actionable under the Lanham Act and common law ABA/Routing #: 021000021 principles. Media Partners: Visit www.coldchainpharm.com for Keep in Contact with Us! exclusive, complimentary content! Follow us on at http://twitter.com/pharmaIQ • Speaker Q&As • News Articles • Podcasts • Presentations from past Join the Group: • Webinars events Cold Chain Distribution for Pharmaceuticals 7 Sponsors:
  • 8. International Quality & Productivity Center REGISTRATION CARD 535 5th Avenue, 8th Floor COLD CHAIN 8 New York, NY 10017 YES! Please register me for: MANAGEMENT & Temperature Control Summit ❑ Conference Only ❑ Workshop(s) Only ❑ All Access ❑ A or ❑ B ❑ C or ❑ D ❑E See Page 7 for pricing details. Your customer registration code is: When registering, please provide the code above. Name__________________________________ Job Title ________________________ Organization____________________________________________________________ Approving Manager______________________________________________________ Address________________________________________________________________ City__________________________________State______________Zip____________ Phone________________________________Fax_______________________________ E-mail__________________________________________________________________ 5 EASY WAYS TO REGISTER: ❑ Please keep me informed via email about this and other related events. 1 Web: www.coldchainpharm.com ❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-800-882-8684 ❑ Charge my __Amex __Visa __Mastercard __Diners Club 3 Email: info@iqpc.com Card #__________________________________Exp. Date___/___ CVM code ______ 4 Fax: 1-646-378-6025 Details for making payment via EFT or wire transfer can be found on preceding page. 5 Mail: IQPC 535 5th Avenue, 8th Floor, ❑ I cannot attend, but please keep me informed of all future events. 11165.004/D/AL New York, NY 10017 The World’s Largest Global Forum of Cold Chain Specialists – Sold out in the US, Canada, Belgium, UK, Brazil, Singapore and Germany COLD CHAIN 8 MANAGEMENT & Temperature Control Summit Strengthening End-to-End Cold Chain February 23-25, 2010 Practices in Distribution, Packaging and Compliance of Temperature Sensitive Westin Harbour Castle Pharmaceuticals Toronto, ON Sponsors:

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