7th cold chain management & temperature control summit

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Strengthening End-to-End Cold Chain Practices to Enhance the Most Critical Steps in Distribution, Packaging and Compliance of Temperature-Sensitive Pharmaceuticals Allan Reynolds Vice President, Industry & Member Relations CANADIAN ASSOCIATION FOR PHARMACY DISTRIBUTION MANAGEMENT (CAPDM) Rafik H. Bishara, PhD Technical Advisor, Chair, Pharmaceutical Cold Chain Interest Group (PCCIG) PARENTERAL DRUG ASSOCIATION (PDA) February 24 – 27, 2009 Four Seasons Hotel Toronto Toronto, Canada Abbott Laboratories American Red Cross Blueye, LLC Canada Border Services Agency (CBSA) Canadian Association of Chain Drug Stores (CACDS) Catalent Pharma Solutions Franwell Inc. Health Canada Johnson & Johnson Medical Products Shared Distribution Centre Medicines and Healthcare Products Regulatory Agency (MHRA) Sea Star Line, LLC Talecris Biotherapeutics, Inc. Transportation Security Administration (TSA) University of Florida US Pharmacopeia (USP) Full-day Intensive Training Class on Reengineering Your Cold Chain by Sherman Cheung, Director of Supply Chain Management, Sanofi Pasteur Hear from Canadian Pharmaceutical companies and Regulatory Agencies: The Latest Update from Health Canada on the Revisions to Guide-0069 Meet Temperature Challenges during Packaging, Warehousing and Transportation How to Maintain Quality in Downstream Distribution and the Last Miles of the Cold Chain Ensuring Optimal Cold Chain Management through the Canadian Distribution Networks Best Practices for Cross-Border Transport and Current Global Regulatory Requirements Avoiding Excursions and Systems for Ensuring Product Quality RFID Systems and ePedigree Compliance Attend and Learn: Register by Nov. 21st & save up to $3,095 www.coldchainpharm.com Conference Co-Chairs: Co-located with Green Packaging – see page 10 for more details Cold Chain Management & Temperature Control Summit TM 7th Annual Lead Sponsor: Badge Sponsor: Sponsors:

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7th Cold Chain Management & Temperature Control Summit (February 24-27 in Toronto, Ontario).

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Page 1: 7th Cold Chain Management & Temperature Control Summit

Strengthening End-to-End Cold Chain Practices to Enhance the Most Critical Steps inDistribution, Packaging and Compliance of Temperature-Sensitive Pharmaceuticals

Allan ReynoldsVice President, Industry & Member RelationsCANADIAN ASSOCIATION FOR PHARMACYDISTRIBUTION MANAGEMENT (CAPDM)

Rafik H. Bishara, PhD Technical Advisor, Chair, Pharmaceutical ColdChain Interest Group (PCCIG) PARENTERAL DRUG ASSOCIATION (PDA)

February 24 – 27, 2009 • Four Seasons Hotel Toronto • Toronto, Canada

Abbott Laboratories

American Red Cross

Blueye, LLCCanada Border ServicesAgency (CBSA)Canadian Association ofChain Drug Stores (CACDS)Catalent Pharma SolutionsFranwell Inc.Health CanadaJohnson & JohnsonMedical Products SharedDistribution Centre

Medicines and HealthcareProducts RegulatoryAgency (MHRA)

Sea Star Line, LLC

Talecris Biotherapeutics,Inc.

Transportation SecurityAdministration (TSA)

University of Florida

US Pharmacopeia (USP)

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

Hear from Canadian Pharmaceuticalcompanies and Regulatory Agencies: • The Latest Update from Health Canada on the Revisions to

Guide-0069

• Meet Temperature Challenges during Packaging,Warehousing and Transportation

• How to Maintain Quality in Downstream Distribution and theLast Miles of the Cold Chain

• Ensuring Optimal Cold Chain Management through theCanadian Distribution Networks

• Best Practices for Cross-Border Transport and Current GlobalRegulatory Requirements

• Avoiding Excursions and Systems for Ensuring Product Quality

• RFID Systems and ePedigree Compliance

Attend and Learn:

Register by Nov. 21st& save up to $3,095

www.coldchainpharm.com

Conference Co-Chairs:

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

Cold Chain Management& Temperature Control SummitTM

7th Annual

Lead Sponsor:

Badge Sponsor:

Sponsors:

Page 2: 7th Cold Chain Management & Temperature Control Summit

Sponsors and Media Partners

Sponsors

Media Partners:

Lead Sponsor:

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

Sponsors:

2 1-800-882-8684 • www.coldchainpharm.com

Badge Sponsor:

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

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

http://www.polyair.com

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

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

Page 3: 7th Cold Chain Management & Temperature Control Summit

Dear Colleague,

With the overwhelming complexity of assuring product integrity throughout thedistribution chain, it is necessary to bring together industry regulators, end-users andvendors to discuss the critical issues impacting the pharmaceutical cold chain. For thisreason, IQPC has brought timely, well thought-out programs to the pharmaceuticalcold chain industry for the past seven years.

Building on the success of last year’s Sixth Annual event in Canada, as well as ourenormously successful U.S. meeting in Philadelphia each September, the SeventhAnnual Canada Cold Chain Management and Temperature Control Summit willaddress the most urgent concerns and challenges of the North American marketplacefor the distribution of temperature-sensitive pharmaceutical products.

While focusing on the always important topics – how to monitor, control and maintaintemperatures of bio pharmaceutical products throughout the supply chain, fromwarehouse, wholesale, pharmacies and hospitals to the end user – this event will alsoprovide delegates with real life solutions and techniques for:

• Implementing or updating an end-to-end cold chain system that complies with thelatest regulations, supports corporate best practices and fits into your cost-benefitanalysis• Wisely choosing partners in your chain, including transportation, packaging, storageand what is necessary to have in your agreement• Monitoring and managing data• Complying with international regulations and understanding what is required whenproduct crosses borders• Effectively dealing with challenges including excursions and audits

We look forward to seeing you this February in Toronto and welcoming you to IQPC’sSeventh Annual Cold Chain Management and Temperature Control Summit!

Lisa RinglenSenior Conference DirectorIQPC

Who Will Attend:Pharmaceutical professionals inSupply Chain, Distribution, QA,Regulatory, Transportation,Packaging, and Security in thefollowing industries:

• Pharmaceutical &Medicine Manufacturing

• Bio-technology

• Medical Laboratories

• Transportation

• Logistics, Cargo & Storage

• Government & Military

• Healthcare & PersonalCare Stores

• Public HealthAdministration

• Medical Equipment &Supplies Manufacturing

3Sponsors:

Strengthening End-to-End Cold Chain Practices to Enhance the Most Critical Steps inDistribution, Packaging and Compliance of Temperature-Sensitive Pharmaceuticals

February 24-27, 2009 • Four Seasons Hotel Toronto • Toronto, Canada

Cold Chain Management& Temperature Control SummitTM

7th Annual

IndustryBreakdown:

■ 56% Pharmaceutical & Medicine Manufacturers

■ 4% Bio-Technology

■ 4% Medical Laboratories

■ 4% Transportation

■ 4% Logistics, Cargo and Storage

■ 4% Government and Military

■ 3% Health and Personal CareStores

■ 3% Public Health ProgramAdministration

■ 2% Medical Equipment andSupplies Manufacturing

■ 16% Other

Page 4: 7th Cold Chain Management & Temperature Control Summit

Abbott Laboratories CanadaAbbott Laboratories, Inc.Alberta Health and WellnessAllergan, Inc.Almac Clinical ServicesAlmac GroupAlternatives Technology PharmaAmerisource BergenBaxter CorporationBCCDCBiomerieux Canada, Inc.Bristol Meyers SquibbCalea Ltd.Canadian Association for Pharmacy DistributionManagementCanadian Blood ServicesCangene CorporationCentral Medical Equiptment DepotCiba VisionCiba Vision Canada, Inc.City Wide Packaging Solutions, Inc.Department of National DefenseDefense Logistics Agency (DLA)Dynamex Canada CorpEMD Serono Canada, Inc.Entropy Solutions, Inc.Envirotainer

The following companies attended last year’s event:

Benefit from attendee interaction!

Form SolutionsGE HealthcareGenzyme CanadaGlaxoSmithKlineHealth CanadaHoffmann-La Roche LimitedHospiraInformation Mediary CorporationInternational Safe Transit AssociationJohnson & Johnson CentocorJohnson & Johnson GPSGJohnson & Johnson Medical, Inc.Materials Management & DistributionMcKesson CanadaMcKesson Logistics SolutionsMerck & Co.Merck Frosst CanadaMeyersMHRAMichigan State UniversityMinistry of Health & Long-Term CareMinnesota Thermal ScienceNovo Nordisk Canada, Inc.NovopharmOncothyreonOntario Ministry of Health

Patheon, Inc.Patient DirectPfizer Canada, Inc.Pharmaceutical Partners of CanadaPharmEng Technology, Inc.PolyairPublic Health Agency of CanadaQuikx Transportation, Inc.Roche DiagnosticsSafety Express - TorontoSanofi AventisSanofi PasteurSanofi Pasteur CanadaSchering PloughSensitechShire PharmaceuticalsSNC Lavalin PharmaTCP Reliable, Inc.Thermal & Protective Packaging, Inc.ThermoSafe BrandsTransition Therapeutics, Inc.US Customs and Border ProtectionWatson Pharmaceuticals, Inc.World Health OrganizationWyeth LaboratoriesWyeth Pharmaceuticals

4

Pre-Conference Training Class Tuesday, February 24, 2009

7:15 Registration for Training Class & Coffee

8:00 am – 4:45 pm

REVIEW, REDESIGN AND REENGINEERING OFCOLD CHAIN MANAGEMENT

Workshop Leader:Sherman Cheung, Director of Supply Chain Management,SANOFI PASTEUR

Session 1: Seven Deadly Myths - The Right and Wrong ofCold Chain Management• Some very critical “Myths” inappropriate traditional

approaches and concepts that seriously affect theperformance Cold Chain Transportation

• The Wrong and Right approaches

Session 2: The Transporters – with an ExtensiveExamination of Airline Carrier Capabilities andCompliance Abilities• Your own Logistics Personnel• Freight Forwarder – Value-added or Road Block process• Carriers• Airlines – comparing, contrasting and evaluating our options• On the road• CourierSpecial Case Study Guest:A Representative of AIR FRANCE

Session 3: The Distribution Itinerary• Why itinerary is critical to cold chain performance• Itinerary Design Criteria• The Transportation Mode• The Carriers• RoutingSpecial Case Study Guest:A Representative of KUEHNE + NAGEL LTD.

12:00 Lunch

Session 4: The Temperature Monitoring and Tracking• Why monitor and track temperature during transportation• Types of monitoring available in the market• Types of monitoring that should be used in different

shipment modes• How to operate different types of monitors• How to interpret the temperature during the shipment• Cold Chain deviation and product loss

Session 5: The Re-engineering of Cold Chain Management• Logistics role in Cold Chain management• Cold Chain performance is not guaranteed• Challenges we are facing• Partnership – why and how?• Training and Education needed for your internal staff and

external partnerships

4:45 End of Training Class

1-800-882-8684 • www.coldchainpharm.com

Page 5: 7th Cold Chain Management & Temperature Control Summit

In North America, warehousing and transportation of Drug Productsare now regulated by guidelines and standards such as HealthCanada’s HPFBI Guide-0069, Parenteral Drug Association’s TechnicalGuide 039, United States Pharmacopeia’s Chapter <1079>,International Safe Transit Association (ISTA) Test Procedures 5B and7D, American Society for Testing and Material (ASTM) Standard TestMethod D 3103-99, ePedigree and other regulations.

It becomes increasingly crucial to use the right technologies in orderto maintain product temperature/humidity during warehousing andtransportation and to monitor and control the cargo temperaturevariances in flight and on the road. The need for enabling

traceability of products to meet new regulations such as ePedigree isat our door. In this presentation, we explore the latest availablesolutions for a safe, efficient and traceable supply chain, and how toensure the implementation of the proper technologies. Thiscomprises monitoring and track & trace solutions such as, time-temperature indicators, data loggers, sensor technologies (RF, RFID,conventional and others), and various models of insulated shippersand refrigerants.

Presented By: Jean Bédard, Chief Executive Officer, ALTERNATIVESTECHNOLOGIE PHARMA

Pre-Conference Workshops Wednesday, February 25, 2009

8:00 am – 11:00 am 7:15 am Registration for Workshop A (Coffee will be served)

NEW TECHNOLOGIES TO MEET TEMPERATURE CHALLENGES DURING WAREHOUSINGAND TRANSPORTATION

A

• The transportation of temperature-controlled product• Best practices that support the pharmaceutical industry’s regulatory

compliance requirements, including: • The benefits of custodial control: How to avoid problems with

multiple handlers and protect Pedigree during transport • How to gain complete visibility of temperature conditions during

and after the shipment • Contingency plans: designing transport systems to enable

effective, preventative intervention• Transportation carrier quality systems: What you should expect

from your carrier

• How concepts of validation can be applied to enhance theconsistency and quality of cold chain transportation

• Case studies of truck validation and air transportationenvironments. • Relative strengths and weaknesses of various approaches at

common temperature ranges: 2-8° C, deep frozen andcontrolled room temperature.

Presented By: Karl Kussow, Quality & Validation Manager,FEDEX CUSTOM CRITICAL

11:15 pm – 2:15 pm 11:00 am Registration for Workshop B (Box Lunch will be served)

TEMPERATURE & TRANSPORTATION: HOW TO MAINTAIN QUALITY IN THE COLD CHAINB

This workshop reviews the latest changes to industry guidance andthe implication for transport service providers. Meeting the industry’srequirements for an effective quality management system isdiscussed in detail with a case study of an approach taken by aplatform provider to ensure effective management of their solution.• Review of current industry guidance (PDA Technical Report #39 /

Health Canada 0069 / IATA Perishable Cargo Manual) • Developing a Quality Management System

• Personnel• Processes and procedures

• Training • Facilities and equipment • Corrective and preventative actions (CAPA) • Audit program

• Case study: Vendor driven training and quality accreditationprogram (QEP)

Presented By: Christopher Fore, Technical Support Manager, ENVIROTAINER, INC

2:30 pm – 5:00 pm 2:15 pm Registration for Workshop C

MEETING TRANSPORT SERVICE PROVIDER OBLIGATIONS FOR MANAGING TEMPERATURESENSITIVE SHIPMENTS

C

This comprehensive workshop is tailored for people responsible forcold chain package design and shipping of pharmaceuticals. It willinclude detailed steps required for success in selecting and designingtemperature controlled shipping solutions. Participants will gain aprecise understanding of the most thorough and effective approachto the critical details related to packaging from design, testing andthrough to qualification.

How You Will Benefit:• Elements required to define the project • New materials available to reduce packaging and their tradeoffs • Methods to establish temperature profiles • Understanding the options and issues for CRT, refrigerated, and

frozen shipments and relating them to the Canadian market

What You Will Learn:• Walk away better prepared to define scope, schedule and cost of

your cold chain project• Attain knowledge of design choices of refrigerants, insulation and

their interaction• Gain an understanding of the elements and advantages of well

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

process

Presented By: Anthony Alleva, Project Engineer, TCP/CRYOPAK Mike Paterno, Project Manager, TCP/CRYOPAK

5:15 pm – 8:15 pm 5:00 pm Registration for Workshop D (Dinner will be served)

COMPLETE TEMPERATURE-CONTROLLED PACKAGING SOLUTIONS FROM NEEDSASSESSMENT TO PACKAGE QUALIFICATION

D

8:15 pm Pre-Conference Workshops conclude

5Sponsors:

Page 6: 7th Cold Chain Management & Temperature Control Summit

Main Conference Day One Thursday, February 26, 2009

7:30 am Registration & Coffee

8:15 am Welcome from IQPC

8:30 am Opening Remarks from the Chairperson

Day One Chair:

Allan Reynolds

Vice President, Industry & Member Relations

CANADIAN ASSOCIATION FOR PHARMACY DISTRIBUTION

MANAGEMENT (CAPDM)

8:45 am OPENING KEYNOTE: UPDATE ON GUIDE-0069

Sarah Skuce

Compliance Specialist

HEALTH CANADA

9:15 am Morning Networking Break

10:00 am PANEL DISCUSSION:REGULATORY AGENCIES UPDATEWith so many rules, regulations and guidelines to consider,

how do you choose the best plan for your organization for

maintaining compliance? This discussion provides a one-stop

place for all the latest on regulations and where you need to

be now and in the foreseeable future. • What is going on with revisions to current GMPs? Update on

GUIDE-0069, USP 1079• New regulations on storage, handling and distribution of

drug samples & mail-order drugs• What is expected by regulatory agencies?• What is next on the regulatory horizon?

Moderator:

Allan Reynolds

Vice President, Industry & Member Relations

CANADIAN ASSOCIATION FOR PHARMACY DISTRIBUTION

MANAGEMENT (CAPDM)

Panelists:

Sarah Skuce

Compliance Specialist

HEALTH CANADA

Mary G. Foster

Packaging and Storage Expert Committee Member

US PHARMACOPEIA

11:00 am PANEL DISCUSSION:DOWNSTREAM DISTRIBUTION AND THE LASTMILES OF THE COLD CHAIN • Provincial Government Level and the last mile, what’s going

on below the federal level?• Retail Pharmacies: What procedures are you using? • How can the manufacturer monitor the product at the

individual pharmacy, wholesaler, physician, hospital, long-

term care facility, community health center, etc.? • Maintaining procedures in rural areas

Panelists:

Heather Tyrrell

Director, Membership & Trade Issues

CANADIAN ASSOCIATION OF CHAIN DRUG STORES

(CACDS)

Ted Prusik

Senior Vice President

TEMPTIME CORPORATION

Arminda Montero

QA Logistics Program Manager

ABBOTT LABORATORIES, INC.

12:00 pm Networking Lunch

1:30 pm CASE STUDY PRESENTATION:STORAGE AND DISTRIBUTION OF DRUGPRODUCTS: ENSURING OPTIMAL COLD CHAINMANAGEMENT THROUGH THE CANADIANDISTRIBUTION NETWORKSIn this presentation, Alternatives Technologie Pharma presents

the Cold Chain Compliance program that was applied

progressively, globally and site by site, to increase the level of

compliance of the five biggest wholesalers in Canada including

35 distribution centers across the country. The implementation

of such a Cold Chain Compliance program enabled these five

major Canadian pharmaceutical wholesalers to upgrade their

cold chain management and to fully comply with the various

guidelines for temperature control of drug products during

storage and transportation.

Presenter:

Jean Bédard

Chief Executive Officer

ALTERNATIVES TECHNOLOGIE PHARMA

6 1-800-882-8684 • www.coldchainpharm.com

“Very knowledgeable speakers.Very relevant for distribution”

- Director, Distribution Operations, Pfizer Canada Inc.

Page 7: 7th Cold Chain Management & Temperature Control Summit

Main Conference Day One ...continued

2:15 pm PANEL DISCUSSION:SEA TRANSPORT OF BIOPHARMACEUTICALPRODUCTS• Exploring cost-effective options by sea transportation

• Pros and cons of sea transportation• Temperature dynamics during the whole distribution chain• Temperature deviation when containers are "unplugged"

during transfers between sea and land carriers• Potentials and benefits of a sea/air/ground integrated

distribution system• Monitoring and new generation of sea containers

• How to monitor ocean container shipments of product

(real time vs data loggers)• How to achieve temperatures colder than -20°C for both

regulatory documentation requirements and for insurance

claim purposes• What type of alarm devices could be incorporated into

containers to alert the shippers/drivers that the air/products

temperature is warming?• Can perfect temperature setting be achieved?• New generation of sea containers (technologies, features)

• Ocean container owners/operators perspectives on CCM• How CCM is achieved during the whole distribution?• What can be done during ground and sea to assure good

CCM• What users should know about sea transportation

operations that may compromise CCM• SOP for temperature sensitive products transported by sea

Panelists:

Jean Vezina

Chief Operating Officer

BLUEYE LLC

Frank Peake

President & Chief Operating Officer

SEA STAR LINE, LLC

Jean Pierre Emond

Professor & Co-Director, Research Center for Food Distribution

& Retailing

UNIVERSITY OF FLORIDA

3:15 pm Afternoon Networking Break

4:00 pm MANUFACTURER TO CONSUMER – DEALINGWITH TEMPERATURE CONTROL CHALLENGESAND REGULATIONS: QUALITY BY DESIGN (QBD)AND GOOD COLD CHAIN MANAGEMENTPRACTICES (GCCMP) - A SCIENCE-BASED

APPROACH FOR DELIVERING QUALITYPRODUCTS AND ENSURING PATIENT SAFETYIndustry leaders are banking cold chain data and statistically

evaluating the performance of their supply chain over time

with the specific goals of improving supply chain performance

and overall efficiency, as well as, lowering costs and

documenting and mitigate risks through the development of

improved Standard Operating Procedures (SOPs). New trends

point toward incorporating the Quality by Design (QbD)

framework into overall Good Cold Chain Management

Practices by monitoring and evaluating cold chain process

performance characteristics scientifically to ultimately ensure

product quality and patient safety.

This presentation will review the concepts above and provide case

study examples to demonstrate the effectiveness of such programs.

Presenters:

Mark Maurice

Senior Project Manager

SENSITECH COLD CHAIN VISIBILITY ADVISORS

Neritan Mustafa

Life Sciences Program Manager

SENSITECH, INC.

4:45 pm EXTENDING GXP BEYOND THE FOUR WALLS:GOOD COLD CHAIN MANAGEMENTPRACTICES ON WHEELSIn this presentation, the speaker will discuss how a cold chain

management program evolved through the partnering and

collaboration of manufacturer and carrier, with a focus on;• Building a relationship with a cold chain provider• Aligning strategy with capability• Developing clear expectations and responsibilities

• Contracts, SOP’s and Quality Agreements• Defining Success

• Measuring performance through KPI’s• Continuous improvement

Presenter:

Jim Bacon

Director of Global Demand Planning & Customer Operations

TALECRIS BIOTHERAPEUTICS, INC.

5:30 pm – 6:30 pm

Networking Cocktail Reception for all delegatesAfter a day of learning and discussions, join your

colleagues from across all disciplines to exchange ideas

and network in an informal environment.

7Sponsors:

Page 8: 7th Cold Chain Management & Temperature Control Summit

Main Conference Day Two Friday, February 27, 2009

8:00 am Registration & Coffee

8:30 am Opening Remarks from the Chairperson

Day Two Chair:

Rafik H. Bishara, PhD

Technical Advisor, Chair, Pharmaceutical Cold Chain Interest

Group (PCCIG)

PARENTERAL DRUG ASSOCIATION (PDA)

8:45 am PANEL DISCUSSION:CROSS-BORDER TRANSPORT/OVERVIEW OFINTERNATIONAL MARKETSPharmaceutical supply chains are global. This discussion will focuson how to maintain/control temp of international shipments in acost-effective manner that meets regulatory compliance, includingthe keys to expanding your supply chain overseas.• Exploring current global regulatory requirements• Comparing and contrasting regulations, procedures and best

practices: Which countries and regions have the bestpractices and how can the Canadian industry adopt them?

• Regulatory harmonization: Overcoming inconsistent laws &regulations

• International shipments in and out of the Canadian market,especially to/from Europe and India

• Customs procedures• International packaging regulations• Expanding your supply chain into emerging markets• International ground transport• Security issues involved in cross-border transport of

pharmaceuticals

Moderator:

Rafik H. Bishara, PhD

Technical Advisor, Chair, Pharmaceutical Cold Chain Interest

Group (PCCIG)

PARENTERAL DRUG ASSOCIATION (PDA)

Panelists:

Boriana Cavicchia

Manager, Systems Quality, Biomedical Services

AMERICAN RED CROSS

Mau'veen Dayrell-Johnson

Senior Officer, Trade Compliance

CANADA BORDER SERVICES AGENCY (CBSA)

Ian Holloway

Manager, Defective Medicines Report Centre

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY

AGENCY (MHRA)

A Representative of TRANSPORTATION SECURITY

ADMINISTRATION (TSA) AIR CARGO SECURITY

10:00 am Morning Networking Break

10:45 am PANEL DISCUSSION:A HOLISTIC APPROACH TO GOOD COLDCHAIN FROM THE PHARMACEUTICALMANUFACTURERS’ PERSPECTIVEWhich companies have successfully introduced a cold chainprogram and what were the keys to cost-effectivecompliance? What are the pharmaceutical companiesexperiencing the most trouble with? What specifically do theyneed from vendors? • Avoiding excursions: Systems for ensuring product quality• What are the key factors that compromise your cold chain

and cause temperature excursion? • Avoiding control gaps when product moves from one piece

of the chain to the next: i.e., from the plane/ship to thetruck and from the truck to the warehouse

• How much monitoring is necessary?• Dealing with excursions: What data is needed? What are

the remedies? How to justify/investigate excursions

Panelists:

Eric Malouin

Distribution & Operations Supervisor

ABBOTT LABORATORIES, INC.

Silvia Castellarin

Logistics Systems Manager

JOHNSON & JOHNSON MEDICAL PRODUCTS SHARED

DISTRIBUTION CENTRE

Jim Bacon

Director of Global Demand Planning & Customer Operations

TALECRIS BIOTHERAPEUTICS, INC.

11:45 am OUTSOURCING GOOD COLD CHAINMANAGEMENT PRACTICES• Cold chain regulations, pharmacopeial standards and industry

best practices• Storage versus distribution temperature(s) for sensitive

medicinal products• Distribution temperature acceptance criteria for cold chain

products• The outsourcing program• Handling, storage and transportation/distribution of

temperature sensitive medicinal products• Temperature profile development: Ambient, hot and

cold profiles• Packaging development: Qualification per Technical

Report 39• Important factors

— Matrixing product packaging — Pack-outs— Monitoring— Performance qualification

8 1-800-882-8684 • www.coldchainpharm.com

Page 9: 7th Cold Chain Management & Temperature Control Summit

Main Conference Day Two ...continued

— Documentation requirements— Training

• The outsourcing program

Presenter:

Rafik H. Bishara, PhD

Technical Advisor, Chair, Pharmaceutical Cold Chain Interest

Group (PCCIG)

PARENTERAL DRUG ASSOCIATION (PDA)

12:30 pm Networking Lunch

1:30 pm Coffee & Dessert in the Exhibit Hall

2:15 pm PANEL DISCUSSION:DATA MANAGEMENT SYSTEMSGood data management can improve your inventory

management, making recalls more efficient and providing the

means to authenticate temperature management and identify

counterfeit drugs. What options are available and which will

work best for your organization?• Radio-frequency identification (RFID) systems: How do they

work? Are they the best option?• Other electronic product codes: What else is available?

• ePedigree compliance• Effective tracking techniques to minimize time wastage• Determining the weak link in your supply chain

Panelists:Jeff WellsPresident & Chief Executive OfficerFRANWELL, INC.

Thomas ReeseBusiness Development - RFIDMOTOROLA ENTERPRISE MOBILITY DIVISION

Jean Pierre EmondProfessor & Co-Director, Research Center for Food Distribution& RetailingUNIVERSITY OF FLORIDA

3:15 pm SMALL GROUP/ROUNDTABLE DISCUSSIONS • Sustainability in Your Cold Chain Procedures• Pharmaceutical Supply Chain Security• The Role of Pharmacies in Maintaining the Cold Chain

4:00 pm Roundtable Summaries:Takeaways from Each Small Group Discussion

4:15 pm Closing Remarks and Program Concludes

9

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

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

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

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

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

Sponsors:

Page 10: 7th Cold Chain Management & Temperature Control Summit

• Learn about the real cost-saving potential ofsustainable packaging

• Define what it really means to be green

• Learn about the newest green technology, materials and solutions

• Understand the emerging world of sustainability regulations

• Examine the cost of sustainability – What is the ROI of going green?

www.iqpc.com/us/green

Benefits of Attending:

Green Packagingis co-located with7th Cold Chain Management and Temperature Control Summit

Register by 12/19/08 and SAVE $500

GreenPackagingGreenPackaging February 25-27, 2009

Toronto, CanadaTM

Rethinking the Sustainable Packaging Paradigm: Emphasizing Good Business Practice

as the Rationale for Going Green

Rethinking the Sustainable Packaging Paradigm: Emphasizing Good Business Practice

as the Rationale for Going Green

For more information on Green Packagingor to download the complete brochure, visitwww.iqpc.com/us/green

Page 11: 7th Cold Chain Management & Temperature Control Summit

Payment Terms:Please note that multiple discounts cannot be combined.

A $99 processing charge will be assessed to all registrations not accompanied by creditcard payment at the time of registration.

MAKE CHECKS PAYABLE IN CANADIAN DOLLARS TO: IQPC* Prices are in Canadian currency and are subject to a 5% GST.

TEAM DISCOUNTS:For information on team discounts, please contact IQPC Customer Service at 1-646-253-5524. Only one discount may be applied per registrant.

Details for making payment via EFT or wire transfer:JPMorgan Chase – Penton Learning Systems LLC dba IQPC: 957-097239 –

ABA/Routing #:021000021Reference: Please include the name of the attendee(s) and the event number: 11165.003

Payment Policy: Payment is due in full at the time of registration and includes lunches,refreshments and detailed conference materials. Your registration will not be confirmeduntil payment is received and may be subject to cancellation.

Please go online to: www.iqpc.com/cancellation to view our cancellation policy

Scholarships Available: IQPC sets aside a limited number of discounts that may beapplied to its conferences for delegates from the non-profit sector, government andmilitary organizations and academia. For more information about scholarships to thisevent, please call Customer Service at 1-646-253-5524.

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

©2009 IQPC. All Rights Reserved. The format, design, content and arrangement of thisbrochure constitute a trademark of IQPC. Unauthorized reproduction will be actionableunder the Lanham Act and common law principles.

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Workshops Only $549 each $549 each $549 each $549 each $549 each $549 each

Training Class $799 $799 $799 $799 $799 $799

All-Access Pass: Attend the 2-Day Main Conference, all 4 Pre-Conference Workshops, and the Training Class *Please specify which workshops you will (save $3,095) (save $1,995) (save $999)attend when registering $2,499 $3,599 $4,595

Green Packaging Main Conference Add-on: Add this upon registration and attend both main conferences*Please note the add-on is for main conference only. $749 $749 $749 $749 $749 $749

See www.iqpc.com/us/green for more information

Pricing

Sponsorships and Exhibits are excellent opportunities for yourcompany to showcase its products and services to high-level,targeted decision makers attending the conference. Pharma IQand the 7th Cold Chain Management and Temperature ControlSummit will help companies like yours achieve sales, marketing andbranding objectives by setting aside a limited number of eventsponsorships and exhibit spaces – all of which are custom-tailoredto help your company create a platform to maximize its exposure atthe event.

For more information on Sponsoring and Exhibiting at the 7th ColdChain Management and Temperature Control Summit, pleasecontact Mack Mendoza at 1-646-253-5524 [email protected].

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

Pharma IQ, the pharmaceutical division of IQPC,provides a forum to address the critical issues facing thepharmaceutical industry today. Pharma IQ utilizesworkshop, conference and training course formats to

facilitate a learning environment for pharmaceutical professional working in allareas of drug development from Discovery to Post-Marketing.

Sponsorship and ExhibitionOpportunities

About the organizer:

Visit us at www.iqpc.com and see what other excitingand information-packed conferences and webinarsbeing offered by the International Quality &Productivity Center.

Conferences and Webinars available:

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5 EASY WAYS TO REGISTER:

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2

1

445

Web: www.coldchainpharm.comCall: 1-646-253-5524Email: [email protected]: 1-646-378-6025Mail: IQPC

535 5th Avenue, 8th Floor, New York, NY 10017

Registration informationCold Chain Management & Temperature Control SummitTM

7th Annual

Four Seasons Hotel Toronto21 Avenue Road, Toronto, Ontario, Canada M5R 2G1Telephone: 1 (416) 964-0411 • Website: www.fourseasons.com/toronto

IQPC has a reduced-rate room block for participants of Cold ChainManagement & Temperature Control Summit at the Four Seasons Hotel Toronto.For room reservations, please call the hotel directly at 416-964-0411. Be sure tomention that you are attending IQPC’s Cold Chain event for the group ratewhen making your reservations.

Venue and Accomodations:

Sponsors:

Page 12: 7th Cold Chain Management & Temperature Control Summit

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

7th Annual Cold Chain Management and Temperature Control Summit

Feb.23rd-26th, 2009 • Toronto, Ontario

Please complete registration form & return to:

Mack Mendoza Tel.: 646-253-5524 Fax: 212-697-4106

E-mail: [email protected] Online Registration : Use Code : NAD/MM and Attn : Mack Mendoza

Please register us to attend as detailed below

Company: Address:

Direct Phone: Email:

Delegate Name: Title: Workshops: Amount:

1)

2)

3)

4)

5)

Total: $

Payment will be made by:

[ ] VISA [ ] AMEX [ ] MasterCard Card No: Expiration Date:

Name of Cardholder: Signature:

*** Any registrations not accompanied by immediate payment will be subject to a $99 service charge ***