cost-effective approaches to quality distribution … toronto 2013 brochure.pdf · cost-effective...

Cost-Effective Approaches to Quality Distribution andLogistics for Temperature Sensitive Products

2013 Summit Highlights:Network and Share Best Practices with 250+ Industry Colleagues and SupplyChain Stakeholders

Meet 30+ Exhibitors Offering the Latest Solutions Available in Canada forDistribution of Quality Control Life Science Products

Learn from Cost-Effective Case Studies and Solutions for a QualityDistribution & Management of Temperature Controlled Medicines in Canada

Develop Supply Chain Partnerships, Relationships and EffectiveCommunication Throughout your Global Supply Network

Sarah SkuceCompliance SpecialistHealth Canada

Maryann GribbinDirector of Quality AssuranceJohnson & Johnson

Mary FosterChair Expert Committee, Packaging, Storage and Distribution of Drug ProductsUnited States Pharmacopeia

Eric Malouin, Ing.CSS, Distribution andOperations Supervisor,Abbott Laboratories Ltd.

Jean-Pierre Emond, Ph.D.Director of Cold Chain ResearchGeorgia Tech ResearchInstitute

Umar Hayat, Ph.D, RACDirector, Product Development and ManufacturingRelypsa, Inc

Attend with industry colleaguesto address business criticalissues, including:

Sponsors:

February 25-28, 2013 | Hyatt Regency, Toronto Canada | www.coldchainpharm.com

Domestic & International Regulatory Updates

Supply Chain Partnerships, Relationships andCommunication Throughout your Global SupplyNetwork

Cold Chain Packaging – Addressing the CanadianMarket’s Concerns

Cost Effective and Quality Based Strategy forCommercial Clinical Supply Chain

Supply Chain Integrity and Secure Cold Chain RiskManagement Process for Canada

Quality Systems & Controls

Ambient Temperature Monitoring and Control

Temperature Control for Product Return and Restocking

Wholesalers Auditing for Temperature Sensitive ProductStorage and Handling

Conference Chairpersons

Rafik H. Bishara, PhDTechnical Advisor and LeaderPCCIG USA BranchPDA

Claude JolicoeurDirector, Regulatory Affairs,Corporate GMP OfficerMcKesson Canada

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Benchmark with 20+ industry and regulatory speakers including:Jim BaconSr. Director, Global Demand Planning & Customer OperationsGrifols, Inc.

Tara ParksSr. Manager, US Affiliate QAUCB Inc.

Shamilla GounderManager, Quality & ComplianceSunovion PharmaceuticalsCanada

Robert BronsteinClinical Supply Project ManagerMacroGenics

Annie NoëlLogistics Director, PharmaceuticalDistribution and OperationsMcKesson Canada

Jim BaconSenior Director, Global DemandPlanning and Customer Operations,Grifols

Rafik H. Bishara, PhDTechnical Advisor and Chair PCCIGUSA BranchPDA

Veronique DamemeVice President, Pharma/HealthcareKuehne + Nagel, Inc.

Sean EisenDirector, Sales and Operations,Sensitech

Rich EllingerPresidentTemperature Assurance Group

Claude JolicoeurDirector, Regulatory Affairs,Corporate GMP OfficerMcKesson Canada

Paul SaratsiotisBusiness Development ManagerWorld Courier Canada

Advisory Board:

Cold Chain IQ www.coldchainiq.com

An international resource center for thetemperature control life scienceprofessional, Cold Chain IQ deliversinsightful, un-biased information abouttoday’s ‘hot topics’. Members (free to join)benefit by reading expert interviews, trend-setting articles and watching podcasts,videos and top rated presentations fromIQPC’s global event series. Cold Chain IQ,part of IQPC, has the largest cold chainpharmaceutical international database,offering strategic partners, members andcontributors an unparalleled opportunity tonetwork, share ideas and disseminate bestpractice information across the globewith peers. Join today!

About the Organizer:

www.coldchainpharm.com • 1-800-885-8684 • [email protected]

Dear Life Science Professionals,

We are excited to bring you the 11th Cold Chain & Temperature Management Summit,February 25-28 2013 in downtown Toronto.

Temperature control and sensitive handling are fundamental requirements of most lifesciences products today. As the supply chain continues to increase in importance, theCanadian market is facing costly challenges resulting from evolving regulations and Federallaws protecting low retail drug costs.

What's New for 2013? The Summit will address new concerns and offer enhancedcoverage on core topics including:• Organizational requirements and how it affects cold chain packaging design, performanceand cost

• Mitigating risk in qualifying active temperature controlled systems• Developing robust and secure cold chain risk management process in Canada• Establishing quality systems & controls from beginning to end• Health Canada's proposed revisions and practical approaches on how to bring yourorganization into compliance

• Addressing temperature control for product return and restocking• Speeding up the import process while reducing costs for incoming temperature sensitiveproducts

• Maintaining product integrity throughout the Supply Chain• Implementing cost effective and quality based clinical supply chains• Containing increased costs associated with ambient temperature products

Don’t miss the chance to network at the largest Canadian event addressing qualitydistribution & management of temperature controlled medicines in Canada. The industry`stop choice for best practice discussions and to see some familiar faces!

Join us and take full advantage of 2013 networking opportunities:• Record number of solution providers: Take full advantage of increased 'browsing' time andactivities in the exhibit hall. See first-hand the latest solutions available in Canada fordistribution of quality control life science products

• Additional interactive formats: Join in-depth interactive discussions. Learn from and sharereal life examples and challenges with your industry peers. Choose among the manyround table discussions, interactive panels and quick fire sessions.

With a special thanks to our Advisory Board and speaking faculty, we've put together abrand new program, covering today's most pressing challenges in temperature controldistribution in Canada and internationally.

On behalf of the IQPC event team, we look forward to meeting you this February in Toronto!

Sincerely,

Claudia RubinoSenior Program Director, IQPC

http://www.coldchainiq.com/

http://www.coldchainiq.com/

Industry breakdown over the past two years:

� 30% Pharma/Medical Manufacturing

� 19% Pharma

� 17% Solution Providers

� 11% Other

� 7% Biotechnology

� 5% Research

� 5% Healthcare

� 4% Pharmacies

� 2% Device Manufacturing

� 2% Laboratories

� 39% Ontario

� 14% Quebec

� 7% CA

� 3% IL

� 3% MA

� 3% MD

� 2% British Columbia

� 2% NY

� 2% TN

� 2% Undefined

� 1% Alberta

� 1% New Brunswick

� 1% CT

� 1% GA

� 1% KY

� 1% MI

� 1% NJ

� 1% Jamaica

� 36% Managers

� 23% Supervisors/Analysts/Specialists

� 19% Directors

� 14% Senior Level Management

� 6% VPs

� 2% Engineers

Where do they come from?

High Level decision makers and key influencers in the industry bring theirknowledge and perspective to the Cold Chain Canada Summit to share with you.

Here’s who came the past two years

“Very educational and informative to help any organization to comply with Health Canada regulations”

- Manager, uniPHARM

14% Growth in attendance in from 2010


Who Does the Cold Chain CanadaSummit Specifically Bring Together?

DescriptionThe combined growth in temperature-sensitive healthcareproducts and the globalization of the industry in terms ofproduction sites continues to create challenges for thoseinvolved in their procurement, distribution and delivery. Inaddition and according to IMS, ‘emerging markets will drivefuture growth for healthcare at a rate of 15%-17%’. All of thisdemands that every participant in the supply chain fortemperature-sensitive healthcare products must know andunderstand the principles and practices behind GoodTransportation Practices and GDP.

Through interactive learning, case studies and group studentparticipation, this unique training course will provide you withthe tools upon which to increase your understanding of end-to-end temperature assurance and the importance of individual

Good Distribution Practices by Air, Road & Ocean for Temperature Sensitive Healthcare Products:Through interactive learning, case studies and group student participation, this unique training course will provide you with the tools upon which to increase your understanding of end-to-endtemperature assurance and the importance of individual practices within the supply chain. Learns the importance of SOP’s and Quality Agreements, trends in distribution and take part in practicaldemonstrations of packaging solutions and temperature monitoring. The course ends with a fun but serious assessment and certification of your learning by taking part in the Cold Chain Game©.

practices within the supply chain. Learn the importance ofSOP’s and Quality Agreements, trends in distribution and takepart in practical demonstrations of packaging solutions andtemperature monitoring. The course ends with a fun butserious assessment and certification of your learning by takingpart in the Cold Chain Game©.

Course Benefits: Gain a detailed understanding of:• The world of healthcare logistics and the increasingpressures of globalization

• The various and varied roles with the logistics supply chain• The regulatory environment for Good Distribution Practices• Good temperature management• Passive and Active transportation solutions• Quality management in logistics

• Best practices in land, sea and air distribution• Service Level Agreements and SOP’s• Improving supplier performance• Audit requirements• Risk Management

Target Audience: This course will be of benefit to all those involved inthe Healthcare Cold Chain process, in particular: • Healthcare product manufacturers including CMO’s• Cargo ground handling companies• Transportation providers – land, ocean and air• Packaging solution providers• Freight forwarding companies• Airlines and air cargo suppliers• Logistics service providers


Pre-Conference 2 Day TrainingMonday February 25th - Tuesday February 26th, 2013

Good Transportation Practices in Temperature-Sensitive Healthcare Logistics

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Welcome & Introduction

The International World of Healthcare Logistics• Terminology, trends & forecasts• Typical product types• Impact of global outsourced production• Cold logistics chain growth• Industry drivers and influences• Trends in distribution – how does this impact upon logistics?

Real drugs for Real People – Case Study OneFrom research to consumer products – how?• Drug costs –why they are so expensive?• The product development cycle • Patents and their application• The difference between generic drugs and biosimilars

Roles and responsibilities in Healthcare companies • Overview of who’s important to whomThe regulatory environment • How regulation has increased• Adulteration, FDA style• Organizations and impact• What regulators focus upon

Responsibility in the supply chain – Let’s map it out! –Group Exercise One

Session One 9:15-12:15 (with suitable break) Session Two 1:00-2:30 (with suitable break) Session Three 3:00-5:00 (with suitable break)

DAY TWO SCHED

ULE Tuesday, February 26th Session Four 9:15-12:00 (with suitable break) Session Five 1:00-2:30 (with suitable break) Session Six 3:45-5:20

Good Temperature Management• What is ‘temperature sensitive’?• The 6 ‘P’s’ of Good Temperature management• Storage & Handling temperature Vs. Producttemperature

• Common temperature ranges• Validation & Qualification explained• Understanding product stability data

Introduction to Basic Thermal Dynamics• Principles of heat transfer• Temperature deviations• Heat transfer in the logistics process

Protect your drug!• What you need to know about Active andPassive Packaging systems

• Phase Change Materials• Choosing the right solution • Universal & Seasonal packaging configurations

Practical packaging demonstrations:Preparing a ‘Passive’ Shipment – GroupExercise Two

Meeting cold chain transportation requirementsAir Cargo • Security – TSA & CCSP• Regulations including IATA Chapter 17 eff. July 12012

• Roles & Responsibilities• Processes• Labeling- what & how• Air Cargo in practice – user videoOcean Transportation • Best practice – industry reefer loading guide video• Check-listRoad Transportation• Best practice loading• Temperature mapping• Qualification• Check-listFacilities• Temperature mapping• Control

Real drugs for Real People – Case Study Two

Temperature Monitoring Devices - Get set foryour overnight exercise!

Review of yesterday

Temperature Monitoring - what we learned fromour overnight exercise• Analysis• Practical issues

Quality Management in Healthcare Logistics• Purpose of a Quality Management System (QMS)• Implementation• Basic Audit Requirements; what do inspectors focus upon?• Preparing for an audit• Risk assessment methodology

Risk Management• Definition and process• Risk evaluation• Control and mitigation

Training • Why so important?• Key aspects• Creating a matrix for your organization

Lets unpack our ‘shipment’ – analysis and review ofresults

Real drugs for Real People – Case Study Three

SOP’s and Quality (Service) Agreements• The role of the Quality (service) agreement

o Responsibilitieso Critical Control Points & Contingencyplans

o KPI’so Improving performance

• The role of the SOP in logistics

An Unorthodox Look at following an SOP- Group Exercise Three• What do I include?• How do I write it?• How can it be effective?

CAPA and its role in GDP• Understanding the purpose of CAPA• Managing CAPA

CAPA Case study - Group Exercise Four• What went wrong?• When, where, why and how• How could we have done better?• Steps for preventive action

Course Review and Assessment‘The Cold Chain Game’

“This course hadexcellent balancebetween lecture,discussion, exercises.Great Tempo!”

- Logistics & Emergency Responses,Center for Disease Control andPrevention (CDC)

Tony Wright, CEO of Exelsius Cold Chain Management hasmany years experience of the distribution and temperature-controlled air cargo sector, having worked as a Senior Executivewith British Airways World Cargo and subsequently as SeniorVice President at Swedish cold-chain container company,Envirotainer. His experiences in these sectors lead Tony to formExelsius in 2007as an international cool chain managementconsultancy. Since then the company has progressively developedinto a foremost provider of independent leadership, consulting,research and education services to manufacturers, airlines,forwarders and other companies in the life science logisticssector. With its unique cross-sector knowledge of the industry,Exelsius has been consulted on a diverse range of projectsaround the world and Tony has been a driving force behind thedevelopment of the IATA Chapter 17 Regulations for Time andTemperature-Sensitive Healthcare Products, having co-authoredthe publication and chair of the working group that created theTime & Temperature-Sensitive air cargo label. Tony is a memberof the Parenteral Drug Association (PDA) and serves on itsEuropean Cold Chain Interest Group as well as being an electedmember of the IATA ‘Time and Temperature Task Force’.

Kevin O’Donnell is Senior Partner at Exelsius Cold ChainManagement. Kevin previously held the position of Directorand Technical Advisor to Industry for Tegrant Corporation,ThermoSafe Brands, the world-leading packaging provider fortime-and temperature-sensitive healthcare products. Prior tohis time at ThermoSafe, Kevin was a Principle PackagingEngineer at Abbott Laboratories Global PharmaceuticalDivision. His 26-year career at Abbott included more than 20years of temperature assurance packaging experience. Heretired from Abbott in 2005. As an engineer, author andeducator, Kevin’s 32-years of experience has centered oncontinuously improving transport packaging, logistics anddistribution within the pharmaceutical industry. He isrecognized internationally as a key opinion leader and devotesmuch of his time promoting and implementing good cold-chain distribution practices. His activities includes: Chair,International Air Transport Association (IATA) Time &Temperature Task Force (2008-2012); Expert CommitteeMember for Packaging, Storage and Distribution, United StatesPharmacopeia Convention: (2010-2015 cycle); TemporaryAdvisor and Mentor, World Health Organization; and memberof the ISTA Thermal Council.

COURSE DESIGNERS AND FACILITATORS:


Pre-Conference Two Day Training continued

Below are some of the ways you can join the Cold Chain community online:

Don’t forget to follow us on Twitter: Cold Chain IQ @ColdChainPharma

Or Like Us on Facebook: www.facebook.com/ColdChainIQ

Join us on LinkedIn – Cold Chain Distribution forPharmaceuticals

Cold Chain IQ is an international resource center that delivers insightful,unbiased information to international temp control life science professionals.

Join your colleagues and competitors to discuss the Cold Chain issues that matter most to you.You will also have first access to program updates, speaker line-ups, and up to the minute news.Join our community today!

Cold Chain & Temperature Management is not just a conference! We are an online community that you are welcome to join at any time.

Visit Cold Chain IQ for exclusive, complimentary content:

• Speaker Q&As

• Podcasts

• Webinars

• News articles

• Presentations from pastevents

A

Cold Chain PackagingSpecification – a 360 DegreeReview how OrganizationalRequirements can Affect ColdChain Packaging Design,Performance and Cost

This workshop will focus on cold chain packaging design and how the application requirements impactthe final outcome. It is intended to promote interaction between the audience and the presenters. Wewill discuss and review issues and concerns presented to packaging provider design teams from theperspectives of Quality Assurance, Supply Chain Logistics, Purchasing, and Engineering.

What you will learn: • What are the main applicationrequirements that impact packagedesign, performance and cost

• Gain a better perspective on issues andconcerns of other organizationaldisciplines

• Understand which trade-offs to considerin deciding the best design for theapplication

How you will benefit: • Take advantage of other departments knowledgeand information in cold chain packaging design

• How to effectively utilize information (internalcompany knowledge) from the other sectors i.e.QA, purchasing, distribution warehousing etc.using real examples regarding what can be donewith information and data provided by othersectors and how it affects packaging designs anperformances

• Cost benefits associated with superiorcollaboration between working groups

Workshop Leaders:

Anthony Alleva, Technical Services Manager,Cryopak, a TCP Reliable Company

Eva Langen, Product Manager, Cryopak, aTCP Reliable Company

How to Reduce theComplexity and Mitigate Riskin Qualifying ActiveTemperature ControlledSystems

This session will offer a comprehensive insight to the different qualification steps and activities as wellas risk assessment. Discussion of the new PDA guidance on “Active Temperature Control Systems:Qualification Guidance” and how it will change future OQs.

What you will learn: • Why qualification is essential • The different steps included in thequalification of active systems and whatto consider for each step

• Requirements for performing thequalification activities for activetemperature control systems

• Design parameters and processcharacteristics that effect the operationof active systems

• How to apply risk-based approaches

How you will benefit: • Understanding the performance qualificationswill reduce the risk of failure during transportand storage

• Understanding the characteristics of activesystems will help you establish robust standardoperation procedures

• The insights may help your company toconsider revising your current qualificationactivities

Workshop Leaders:

Carolina Lundquist, Head of Cold ChainConsulting, Envirotainer

Berkley Stafford, Head of Healthcare Sales,The Americas, Envirotainer

11:30–2:30 11:15 Registration (Lunch will be served)

Pre-Conference Interactive WorkshopsTuesday, February 26th

B

8:00–11:00 7:15 Registration (Coffee will be served)


CMost Common MistakesObserved in InsulatedContainers for the Transportof Cold Chain Pharmaceuticals

This workshop will present different scenarios of cold chain pharmaceutical shipments that did notmaintain the required temperature range. The top most common problems will be presented,allowing teams to work together to determine the cause of temperature failure and methods toresolve them.

What you will learn: • Understand thermal behavior inside aninsulated container

• Understand the dynamic of temperaturedistribution inside a shipping package

• Learn about the impacts of shippingenvironments

• Learn about the human factor in apacking line operation

How you will benefit: • Avoid common mistakes on your future coldchain pharmaceutical shipments

• Gaining the ability to successfully determine thecause of temperature failures

• Gain insight of potential solutions and methodsto resolve temperature failures

Workshop Leaders:

Jean-Pierre Emond, Ph.D., Director of ColdChain Research, Georgia Tech ResearchInstitute

Melissa Germain, M.Sc., Assistant Director ofCold Chain Research, Georgia Tech ResearchInstitute

11:30–2:30 11:15 Registration (Lunch will be served)

DHealth Canada Guidance 0069:Practical Approaches on Howto Bring your Organizationinto Compliance

This workshop will examine practical approaches to how companies are implementing Health Canada'sguidance revisions. We will examine actual cases from companies and how they are distributingproducts in Canada according to 0069, key challenges, potential solutions and hands-on exercises. Thisinteractive workshop will highlight critical distribution areas under the guidance including:

What you will learn: • Overview and examples of Health Canadaobservations

• Real life examples effecting all criticaldistribution areas

• Key observations and recommendationsfrom a regulatory perspective to help ensureyour organization's compliance

• Potential solutions from hands-on exercises

How you will benefit: • Ensure your organizations compliance • Address your organizations specificchallenges

• Learn directly from a regulatorsperspective

• Hands-on exercises addressing keyindustry challenges and pitfalls

• Temperature excursions and shipping conditions• Warehousing and storage • Documentation

Workshop Leaders:

Sarah Skuce, Compliance Specialist,Health Canada

Rafik H. Bishara, PhD, Technical Advisor &Leader PCCIG, PDA

3:00– 6:00 2:45 Registration for Workshop C

• Product transportation and productsin transit

• Containers and container labelling

CONCURRENT W

ORKSHOPS • CHOOSE B

OR C

12:10 Addressing Import Challenges for IncomingTemperature Controlled Products to Canada• Typical challenges encountered during imports• Expediting the process for incoming products• Practical ways to reduce costs relating to imports• Steps to address key issues including paperwork, counterfeit,data requirements etc.

• Key lessons learned and takeaways

Rafik H. Bishara, PhD, Technical Advisor & Leader PCCIG, PDA

Shamilla Gounder, Manager, Quality & Compliance, SunovionPharmaceuticals Canada Inc.

Alan J. Davis, Supply Chain Temperature Control Leader,Johnson & Johnson

12:50 Lunch

1:50 Networking Round Table DiscussionsThis is your chance to bring your challenges, issues and sharecommon ideas/mistakes with your peers. Learn from interactiveconversations over common challenges and take them head on!Join one of the networking round table discussions lead byindustry thought leaders:

1. Information Technology, Communication and theEscalation Process in the Supply ChainLead by: Alan J. Davis, Supply Chain Temperature ControlLeader, Johnson & Johnson

2. Sharing of Temperature Allowable Excursions and ofInformation with ManufacturerLead by: Claude Jolicoeur, Director, Regulatory AffairsCorporate GMP officer, McKesson Canada

3. Key Pillars in the Supply Chain for Temperature ControlsEric Malouin, Ing. CSS, Distribution and OperationsSupervisor, Abbott Laboratories Ltd.

4. DuPont™ Tyvek® Air Cargo Covers: Ideal Protectionfor Temperature and Moisture Sensitive CargoLead By:Paul F. Herman, Tyvek® NA Technical Leader, DuPont™Josée Ricard, National Sales Manager, DuPont™ - Canada

5. The Trucking Industry’s View on Canada’s Supply ChainTransportation

6. Examining Logistics Challenges and Packaging Optionsfor the Canadian Market

7. Defining a Temperature Excursion Global CompanyPolicy

8. Health Canada Validated Warehouses

9. Developing a Shipping Qualification Master PlanIncluding “Last-Mile” Distribution

7:45 Registration & Breakfast

8:45 Welcome Remarks by IQPC

8:50 Opening Remarks Chairperson: TemperatureControl Distribution Around the World: AReport from IQPC's Global Cold Chain EventSeries & Advisors • Feedback from IQPC Riyadh, Saudi Arabia: Unique aspects ofdistribution in the Middle East

• Feedback from IQPC, Chicago: USA distribution highlights• Feedback from IQPC, Basel: Pan-European distribution highlights• Cold Chain IQ• Global Cold Chain and related events - Forward schedule

Rafik H. Bishara, PhD, Technical Advisor & Leader PCCIG, PDA

9:10 Reviewing Health Canada's Proposed Revisionsto Good Distribution Practices (GDP)• Guidelines to temperature control of products during storage andtransportation (GUI-0069)

• Shipping outside of label requirements• Stability data and evidence to support excursions• Contingency planning requirements (i.e. emergency situationsand trouble at the border)

• Alternatives to mapping and monitoring

Sarah Skuce, Compliance Specialist, Health Canada

9:50 The Bridge Between GMP and GDP - ARegulator point of View• MHRA' s Bridging of GMP and GDP• Updates on EU Guidance on GDP• Inspections Trends• Recommendations for Good Supply Chain Integrity• Other point of discussion according to your experience

Ian Holloway, Head of the Defective Medicines Report Centre,MHRA

10:30 Networking Break

Join your peers to browse the 2013 Solution Hall where you’ll beable to find all the latest packaging/container, transportation,logistics, temperature monitoring, security, and data managementsolutions. The ideal place to meet existing and new partners.

11:30 USP Update on Good Distribution Practices -Supply Chain Integrity <1083>• Perspectives on the USP's approach to Good Distribution Practices• Ensuring the integrity of key areas of the Supply Chain• Good importation practices• Adherence to labeled storage conditions• Combating counterfeit drugs, diversion and theft

Mary Foster, Chair Expert Committee, Packaging, Storage andDistribution of Drug Products, United States Pharmacopeia

Main Conference Day OneWednesday, February 27th


“Comprehensive information,well organized and great

interaction”- Senior Account Manager, Thermosafe

Track A: Supply Chain Integrity & Security Track B: Quality Clinical Supply Chain

5:30 End of Conference Day One

5:45 Cocktail Reception in Exhibition HallJoin your peers to browse the 2013 Solution Hall where you’ll beable to find all the latest packaging/container, transportation,logistics, temperature monitoring and data managementsolutions. The ideal place to meet existing and new partners!

4:00 Case Study: Turkey`s Pharmaceutical TrackingSystem (ITS)• Ensuring reliable supply of drugs to patients• Preventing counterfeit, fraud, smuggling• Effectiveness in preventing bar coder scams• Supporting rational drug use: supplying data to control market• Maintaining current theft and fraud levels at zero

Taha Yayci, M.S., Republic of Turkey, Ministry of Health

4:40 A Growing Global Threat to High Value Cargo:Fraudulent Pick-Up

In Europe, Asia, Latin and North America we are seeing an increasingnumber of thefts by fraudulent pick-up. Using the internet to createfraudulent documents, stealing identities of legitimate carriers, andcreating false delivery addresses. • Methods of Fraudulent Pick-Up theft• Preventing Fraudulent Pick-Up Theft and the Application of Standards asBest Practice

• How thieves are using the transportation system itself to steal cargo

Alan F. Spear, Chair, TAPA Americas

Clinical Supply Chain: Setting Up the Stage for Cost& Quality of a Commercial Supply Chain• Phase appropriate development and cost deployment • Clinical Supply Chain management• Major pitfalls and lessons learned• Cost controlling factors• Commercial supply chain = f(clinical supply chain)

Umar Hayat, Ph.D, RAC, Director, Product Development andManufacturing, Relypsa, Inc

Addressing the Challenges - Planning a Strategy forGlobal Distribution of Temperature Sensitive ClinicalSupplies• Challenges facing small to medium size biopharma companiesestablishing a global clinical cold supply chain

• Aligning product stability profiles with packaging and shippingrequirements

• Streamlining global pathways to improve time-to-site of temperaturesensitive CTM

• Supply chain partnerships - developing relationships and effectivecommunication throughout your global supply network

• Avoiding common pitfalls through lessons learned

Robert Bronstein, Director, Clinical Supply Operations, MacroGenics, Inc.

Concurrent Tracks Begins. Choose Track A or B

Main Conference Day One continued


Track A: Supply Chain Integrity & Security Track B: ISTA – Packaging by Design

ISTA’s New Responsible Packaging by Design• Responsible Packaging by Design, a voluntary process managementstandard

• Provides a step by step roadmap for the process of establishingpackaging sustainability metrics, developing data, and evaluating all ofthe functional and environmental requirements for packaging systems

• This presentation will discuss the eight steps comprising the process aswell as preview provided templates to assist in process documentation

Larry Dull, Vice President – Sustainable Solutions, ISTA

2:35 Closing the Reality Gap Between RegulatoryRequirements and the Practicality of MaintainingSupply Chain Integrity• What are the regulators telling us?- Dealing with a non harmonized, multi agency, global challenge

• Monsters vs Aliens1. How to navigate the maze of import & export regulators

• Thinking beyond the box!1. Packaging Selection – A different horse for every course2. Validation & Qualification – Where are we going today?

• A risk based approach and contingency planning – What to focus on

Dan Bell, Director Commercial Operations, & Regulatory Compliance, Marken

Paddy Hanlon, Senior Director, Business Development, Marken


Join your peers to browse the 2013 Solution Hall where you’ll be able to find all the latest packaging/container, transportation, logistics, temperaturemonitoring, security and data management solutions. The ideal place to meet existing and new partners.

8:00 Registration & Breakfast

8:45 Opening Remarks by Chairman

Claude Jolicoeur, Director, Regulatory Affairs Corporate GMPofficer, McKesson Canada

9:00 Panel Discussion: Interpreting the HealthCanada Guidelines: The Industries Perspective• Guidelines to temperature control of products during storage andtransportation (GUI-0069)

• Shipping outside of label requirements• Stability data and evidence to support excursions• Contingency planning requirements (i.e./ emergency situations,trouble at the border)

• Alternatives to mapping and monitoring• Practical experience following Health Canada`s guidelines (GUI-0069)

Eric Malouin, Ing. CSS, Distribution and Operations Supervisor,Abbott Laboratories Ltd.


Maryann Gribbin, Director of Quality Assurance, Johnson &Johnson

9:40 Developing a Robust and Secure Cold ChainRisk Management Process in Canada

The integrity and reliability of a solution can be attributed to strongand collaborative partnering of shipper and provider. In thispresentation we’ll review how we created a robust carrier programthat provides gold standard service and meets regulator guidelines.• Addressing our requirements – aligning strategy with carriercapability

• Establishing a relationship including Quality System and ValidationProtocol with the carrier

• Reviewing qualification, security measures, and robustness ofthese in the risk management equation

• Creating a repeatable and transferable process/program forsuccess and a win/win result

Jim Bacon, Senior Director, Global Demand Planning & CustomerOperations, Grifols, Inc.


Join your peers to browse the 2013 Solution Hall where you’ll beable to find all the latest packaging/container, transportation,logistics, temperature monitoring, security and data managementsolutions. The ideal place to meet existing and new partners.


Main Conference Day TwoThursday, February 28th

11:20 Establishing Quality Systems & Controls fromBeginning to End

Setting up a robust quality system involves many key elements thatmerit focused attention. This session will be highlighting these keyareas and provide a best practice approach to establishing anoverall solid quality system. • Supply chain management from receipt• Quality system oversight of the supply chain• Implementing quality controls:- Receipts- Storage- Transportation- Stability and handling deviations- Supplier & quality agreements

• Addressing key challenges

Maryann Gribbin, Director of Quality Assurance, Johnson &Johnson

12:00 Panel Discussion: Is it Worth the Risk of NotMonitoring Within a Qualified Packout?• Defining what is considered a Qualified and Pre-Qualifiedpackout

• The risks still associated to products even with the “data” on apackout

• Risks associated to not monitoring pre-qualified packouts• Benefits and drawbacks to completing IQOQPQ for packouts asit relates specifically to a manufacturers or distributorsdistribution processes and operations

• Key drawbacks and lessons learned

Alan J. Davis, Supply Chain Temperature Control Leader,Johnson & Johnson

Henry Ames, Strategic Marketing Director, Sensitech

Sarah Skuce, Compliance Specialist, Health Canada

12:40 Networking Lunch

1:40 Temperature Control for Product Return andRestocking• Quality Control requirements - Interpreting regulation C.02.014 • Assessing product quality for resale/restocking for productreturns

• Best practice for handling of returned goods• Regulatory compliance and quality control• Establishing plans for product examination and restocking• Evaluating all risks• Documentation available to support the rationale to placereturned goods into inventory for further resale

Shamilla Gounder, Manager, Quality & Compliance, SunovionPharmaceuticals Canada Inc.

COLD CHAIN & TEMPERATURE MANAGEMENT CANADA RESOURCE CENTER!

You can access relevant industry surveys & articles, speaker interviews, presentations, research papers and much more atwww.coldchainpharm.com. All content is free, available 24/7 and new content is added regularly!

If you have something you would like to contribute to the Resource Center, email [email protected].

2:20 Auditing Wholesalers for TemperatureSensitive Product Storage and Handling• Standards to consider for wholesalers • Are products kept at label temperature in the warehouse?• Is the wholesaler considering the last mile?• Does temperature mapping apply to the wholesaler?• Awareness and education

Tara Parks, Sr. Manager, US Affiliate QA, UCB Inc.


Join your peers to browse the 2013 Solution Hall where you’ll beable to find all the latest packaging/container, transportation,logistics, temperature monitoring, security and data managementsolutions. The ideal place to meet existing and new partners.

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Experience Hyatt Regency Toronto’s location in the center of the city’svibrant downtown. Fresh from a multi-million dollar renovation, oursparkling Toronto downtown hotel showcases 394 guestrooms, including32 suites. Your perfect hub for business or pleasure travel, our downtownToronto hotel accommodations are just steps from the business andfinancial districts, the convention centre and over 150 restaurants andbars. Stage your next event in 25,000 square feet of meeting space.

Explore attractions like the Royal Ontario Museum or the Opera House– ourHyatt Toronto hotel is adjacent to the Theatre District. Take a shopping trip toEaton Centre, trendy Queen Street, or exclusive Yorkville. Whether you arevisiting the Hyatt Regency Toronto for business or pleasure, our associates areready to provide you with exceptional service and personal attention.

Group Rate: $169 plus 13% taxesPlease identify you are part of the IQPC – Cold Chain Canada to ensurethe special rate, based on availability. Note that you are eligible for thisrate three days prior and three days post the event, based on availability.Book your room prior to February 5, 2013.

Reservations Phone: (888) 421-1442

Main Conference Day Two continued

3:45 Ambient Temperature Monitoring and Control• Defining the right structure and team• Containing the increase costs associated with ambienttemperature products

• Obtaining support from upper management• Educating and effectively working with your carriers

Annie Noël, Logistics Director, Pharmaceutical Distribution andOperations, McKesson Canada


4:25 End of Conference Day Two


VENUE INFORMATION

MEDIA PARTNERS

SPONSORSHIP AND EXHIBITION OPPORTUNITIES

Sponsorships and exhibits are excellent opportunities for yourcompany to showcase its products and services to high-level, targeteddecision makers attending the Cold Chain & TemperatureManagement Summit - Canada.

IQPC helps companies like yours achieve important sales, marketingand branding objectives by setting aside a limited number of event

sponsorships and exhibit spaces – all of which are tailored to assistyour organization in creating a platform to maximize its exposure atthe event.

For more information on sponsoring or exhibiting at this orupcoming events, please contact Simon Copcutt at 1 (212) 885-2771 or [email protected]

A BRAND

American AerogelWebsite: americanaerogel.comAmerican Aerogel develops and manufactures performance-leading

aerogel-based insulation products currently used in thermal packaging systems for the transportation oftemperature sensitive products. For the past seven years, AAC has provided cold chain solutions forcustomers transporting biomedical, pharmaceutical, medical devices and clinical trial and diagnostic testingsamples. American Aerogel founders started initial research in 1999 and worked for seven years perfectingthe process by which to manufacture the world’s only organic monolith aerogels. In 2008, the companybuilt its first pilot line and in 2011 completed a major expansion of its manufacturing facility. With aplanned further capacity expansion for the end of 2012, American Aerogel is committed to growing andkeeping up with its customer’s needs in this rapidly expanding market.

ATS HealthcareWebsite: www.atshealthcare.caBuilding enduring relationships by delivering integrated solutions with passion andinnovation! The challenge envisioned a decade ago – to build a business dedicated

to answering healthcare’s biggest issue, time-definite, temperature-controlled transportation – has becomea reality. Today, ATS Healthcare is the largest, most reputable provider in Canada’s temperature controlledhealthcare transportation industry. Healthcare and cosmetic manufacturers, wholesalers and theircustomers appreciate our reliable end-to-end solutions to their temperature management, security andother shipping requirements. Our standards are the highest, complying with Health Canada guidelines forthe transportation of temperature sensitive products such as pharmaceuticals, cosmetics, medical devicesand over-the-counter products. SNC Lavalin Pharma has recognized our high standards through thequalification of our systems and procedures. In combination with 24/7 tracking, data capture and retention,our nationwide network of temperature managed facilities and the highest level of security, ATS Healthcareprovides shippers a clean, efficient and committed healthcare focused solution.

BerlingerWebsite: www.berlinger.comInnovation has propelled the Berlinger Company through the past 150years. Our customer base challenges us to build intelligent decision

making tools for the entire cold chain process. Now a temperature sensitive product can be monitoredthrough the entire distribution cycle, including the last mile. Berlinger products are approved by the WHO,UNICEF, and PATH. They are used for monitoring product temperatures in storage and transportation. Wewelcome your next temperature monitoring challenge.

CedarlaneWebsite: www.cedarlane.caCEDARLANE is an ISO 9001:2008 and ISO 13485:2003 registered

privately held Canadian Corporation. CEDARLANE SHIPPING SUPPLIES was established as a response to thegrowing need for temperature sensitive shipping supplies within the biotech and food service industries.We offer a complete line of engineered climate control products for storage and transportation ofperishable and time sensitive goods. Specialties are gel & foam ice packs, Styrofoam insulated shippingcartons and expanded polystyrene (EPS) insulated shipping cartons, offering you everything you need tomake sure your important shipments arrive in good standing, every time.Cedarlane Shipping Supplies – GotYour Temperature Under Control?

Cold Chain Technologies (CCT)Website: www.coldchaintech.comCold Chain Technologies (CCT) is a leading global provider of insulatedthermal packaging solutions that protect the integrity of temperature sensitive

products. We offer a wide range of cost-effective packaging options for JIT delivery, including standard andcustom KoolTemp containers, Koolit refrigerants and temperature indicators and loggers. Our team ofexperts draws upon unrivaled experience throughout the cold chain, from design and testing to thermalmodeling and total project management. With multiple sites across the U.S. and partnership in Europe, weprovide local support of global shipping needs, ensuring product safety through the industry's largestselection of smart solutions.

CryopakWebsite: www.cryopak.comCryopak (a TCP Reliable Company), specializes in the field of temperaturecontrolled packaging and services including package design,

qualification, testing manufacturing insulated shippers, refrigerants, phase change materials andtemperature monitors. All services are provided in strict conformance with ISO 9001:2000, ISTA and ASTMtest methodology, and FDA good manufacturing practices. TCP maintains facilities in Quebec, BritishColumbia, New Jersey and France.

DupontWebsite: www.aircargocovers.dupont.comDuPont Tyvek(R) Air Cargo Cover - Introduction words DuPont™ Tyvek® Air CargoCovers offer better control of temperature and moisture in shipments thantraditional blankets and plastic wraps, which makes them ideal for shippers of

perishables such as pharmaceutical, fruit, vegetable and floral products. They help reduce spoilage bylimiting exposure to environmental elements, lowering exposure to sudden ambient temperature changes,both heat and freezing temperatures, and to environmental elements. Tyvek® Air Cargo covers provideideal protection for temperature sensitive shipments because they are breathable, compact, lightweight andeasy to apply and remove.

Elpro Services, Inc.Website: www.elpro.us/home.htmlElpro Services, Inc. is a leading manufacturer of high quality temperature,humidity, and CO2 dataloggers, providing recording and monitoring solutions

while observing regulatory compliances (GMP/GLP/FDA 21CFR11). LAN/W-LAN solutions are fully scalableto meet your central monitoring requirements and future growth. Our New Libero PDF-logger® (NoSoftware Required) provides simple cold chain monitoring of temperature sensitive pharmaceuticals. Thisground-breaking concept of producing the report in a PDF file eliminates the need to install, qualify andvalidate any specific software at destination. Available in 100 and 400 day models, our Libero PDFlogger ®also supports compliance with FDA standard 21 CFR 11.

EnvirotainerWebsite: www.envirotainer.comPioneer and market leader Envirotainer offers flexible leasing (rental) of

advanced transport solutions for worldwide air cargo shipments of temperature-sensitive products.Customers within the healthcare, life sciences and high-tech industries benefit from the combination ofadvanced container technology, extensive cold chain management services and a global network of servicepartners, airlines and forwarders – providing a unique one-way leasing service. Envirotainer secures thesafety and integrity of product cold chains by providing an active temperature-control system, training allparties along the cold chain and supporting customers in transport validations and risk management. Withsales representation in 17 countries, the company has its R&D, Manufacturing and Quality Assurancedepartments at the headquarter premises in Lagga Marma near Stockholm, Sweden.

Intelligent Thermal SolutionsIntelligent Thermal Solutions is a south Texas company headquartered in Kingsville, TXpreviously known as Active CC Boxes LLC. ITS manufactures reusable cold chainshipping containers with extended hold times meeting the unique safety needs ofpharmaceutical and biologics companies. EcoTherm™ containers overcome thecumbersome limitations of corrugated boxes lined with polystyrene or urethaneinsulation and filled with dry ice or frozen gel packs. The technology in EcoTherm™

containers was recognized in 2002 with the Dupont Gold Award for packaging design innovation forcold chain, and the 2002 R&D 100 Awards recognizing the 100 most technologically-significantproducts of 2002.

Kuehne + NagelWebsite: www.kn-portal.comKuehne + Nagel is a world leader in providing integrated logistics services formanufacturers of pharmaceuticals, biotechnology, medical devices and otherhealthcare products. Our services and solutions are designed to meet the

exacting operational requirements of this regulated environment (GxP). We do significant business withsome of the world’s leading pharmaceutical/healthcare companies, as well as other select customers inthe pharmaceutical, medical equipment, animal drugs, personal care and infant formula categories.Kuehne + Nagel has developed a wide range of supply chain and information management services tooptimally manage healthcare firms' complex global procurement and supply chain processes. We willassess current customer supply chain processes against standard and industry benchmarks to identifyareas for improvement. Using advanced analysis and modeling tools, alternate models are evaluatedagainst identified cost and service objectives to arrive at the optimal solution. Kuehne + Nagel providesvisibility and control over inventory flows. KN Login enables proactive management of your supply chainthrough improved end-to-end visibility and dynamic, intelligent exception alerting.

MarkenWebsite: www.marken.comMarken is one of the leading suppliers of cold-chain logistics for clinicalsupplies worldwide. Temperature-control during the handling, storageand distribution of cold-chain products is a critical element of the clinical

trial process. Our expertise is of critical importance to ensuring the safe arrival of high value shipments tosites. We provide:• Global distribution of temperature controlled trial medication, vaccines & CTM• Temperature control monitoring for ambient, 2-8C and frozen products to maintain integrity ofsupplies

• Advice on packaging materials and provision of containers for global transportation• Refrigerated trucking services• Customs brokerage accelerating clearance

Minnesota Thermal Science, LLCWebsite: www.mnthermalscience.comMinnesota Thermal Science is a global temperature control industry leaderproviding a comprehensive range of advanced performance thermalprotection packaging solutions that meet the global distribution needs of their

pharmaceutical, tissue, diagnostics/biologics, clinical trial and blood supply customers. At thecornerstone is the reusable Credo® container that protects payload contents at specifically definedranges longer than any other passive thermal control product available.

ROBERTWebsite: www.robert.caFounded in 1946, Robert proudly upholds a tradition of excellence that hasmade it a leader in the North American asset based supply chain managementsector. We owe our success to our 3,300 dedicated employees and ourexpertise in delivering state-of-the-art logistics, distribution and transportation

solutions. Multiple times in it’s history Robert has chosen to take on new challenges. The keys remainconstant, education, quality and dedication. As we evolve we will strive to continue to do what we havealways done, create serious solutions for serious people.

SensitechWebsite: www.sensitech.comSensitech - The leading provider of cold chain visibility solutions that enable ourcustomers to track and monitor assets across the supply chain, protecting thequality, efficacy, and integrity of their temperature-sensitive products. Our

product portfolio includes comprehensive analytic services, enterprise software systems and validateddata acquisition devices. We address our customers’ most complex perishable cold chain problems anddeliver powerful insights that drive measurable process improvement. Sensitech supports cold chainmonitoring programs in 18 of the top 20 multi-national pharmaceutical companies and 9 of the top 10biopharmaceutical companies. Sensitech is a business unit of Carrier Corp.

Skelton Truck LinesWebsite: www.skeltontruck.comSkelton has provided refrigerated services for 28 years toPharmaceutical/Biological companies. We partner with customers to ensure

we maintain product integrity through out the cold chain link. Our Critical Care Division validated trailersare devoted for products that require 2°C to 8°C with double reefers units to ensure the safety of theproducts. Our investment in assets, people and training have provided our customers with a Tried, Testedand Proven solution that meets and exceeds Health Canada 0069 regulations.

World Courier of Canada Ltd.Website: www.worldcourier.comWorld Courier has set the benchmark for worldwide time &temperature sensitive transportation. We remain the only specialist

courier company with its own global company network .Each office ISO 9001 certified with the sameoperating standards dedicated to treating every shipment on an individual, priority basis. World Courieris utilized in approximately 80% of the world’s clinical trials requiring the use of a specialty courier. Withexperience in managing the logistics of over 7,500 clinical trials worldwide, we are the acknowledgedexperts in handling temperaturesensitive specimen and drug shipments.


About Our Sponsors

Please note multiple discounts cannot be combined.

A $99 processing charge will be assessed to all registrations not accompanied by credit card payment atthe time of registration.

MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC

All prices are subject to a 13% HST*CT residents or people employed in the state of CT must add 6.35% sales tax

Team Discounts: For information on team discounts, please contact IQPC Customer Service at 1-800-882-8684. Only one discount may be applied per registrant.

Special Discounts Available: A limited number of discounts are available for the non-profit sector,government organizations and academia. For more information, please contact customer service at 1-800-882-8684.

Details for making payment via EFT or wire transfer:JPMorgan Chase - Penton Learning Systems LLC dbaIQPC: 937332641ABA/Routing #: 021000021Reference: 11165.007

Payment Policy: Payment is due in full at the time of registration and includes lunches andrefreshment. Your registration will not be confirmed until payment is received and may be subject tocancellation.

For IQPC’s Cancellation, Postponement and Substitution Policy, please visit www.iqpc.com/cancellation

Special Dietary Needs: If you have a dietary restriction, please contact Customer Service at 1-800-882-8684 to discuss your specific needs.

©2012 IQPC. All Rights Reserved. The format, design, content and arrangement of this brochureconstitute a trademark of IQPC. Unauthorized reproduction will be actionable under the Lanham Actand common law principles.

Training Days: Monday, February 25 & Tuesday, February 26, 2013

Workshop Day: Tuesday, February 26, 2013

Main Conference Days: Wednesday, February 27 & Thursday, February 28

*Please note Workshop Day is Concurrent with 2nd Training Day(February 26, 2013)

YES! Please Register Me For:

� Summit Only � Conference + 3 Workshops � Training Days � Workshop(s) � A � B � C � D

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� I cannot attend, but please keep me informed of all future events.

(Email this form to [email protected] or fax to 646-378-6025)

11165.007/TS

Registration InformationRegister by Register by Register by Standard11/16/2012 12/14/2012 1/31/2013 Price

Conference Only $1,299 $1,499 $1,699 $1,999

Conference $2646 $2746 $2946 $3646+ 3 Workshops (SAVE $1000) (SAVE $900) (SAVE $700)

Conference $3198 $3298 $3398 $3798& Training Days (SAVE $600) (SAVE $500) (SAVE $400)

Register by Standard1/31/2013 Price

Conference Only $1,699 $1,999 (SAVE $300)

Conference + 3 Workshops $2,946 $3,646(SAVE $700)

Conference & Training Days $3,398 $3,798(SAVE $400)

Register by Standard1/31/2013 Price

Conference Only $2,499 $2,799(SAVE $300)

Conference + 3 Workshops $3,999 $4,199 (SAVE $200)

Conference & Training Days $4,198 $4,598(SAVE $400)

StandardPrice

Training Days $1,799

Workshop Only $549 Each


Cost-Effective Approaches to Quality Distribution andLogistics for Temperature Sensitive Products

February 25-28, 2013 | Hyatt Regency, Toronto Canada | www.coldchainpharm.com

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