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✔ Sit down with Health Canada to discuss the updates to <0069> (due out by
early 2011) and understand what prompts inspections and what they look for during
audits
✔ Understand new PCCIG guidance around Risk Management, Stability Data during
'In transit' and Technical Report 46 on 'Last Miles'
✔ Improve quality throughout your supply chain organization by collaborating
with logistics teams and structuring your organization in a way that embeds QA into
everyday logistics
✔ Ensure compliance by understanding and comparing GDP updated regulations
around the globe and considerations for temperature control distribution
✔ Define a CRT or Ambient approach to temperature mapping study, route profiling
and risk assessment for specific channels
✔ Hear the wholesaler perspective on sharing stability data and collaborating with
the manufacturer to ensure supply chain and patient safety
Presents the
CC
February 22 - 24, 2011
Westin Prince Hotel, Toronto, Ontario, Canada
www.ColdChainPharm.com/Quality
Sponsored By:
Join 200+ of your industry colleagues at the only
Canadian event for cold chain and temperature
controlled pharmaceuticals. Attend to:
Hear from experts
in the industry:
Health Canada
Transport Canada
Canada Border Services
Agency
Eli Lilly, Canada
Canadian Association
for Pharmacy
Distribution
Management (CAPDM)
McKesson Canada
Medicines and
Healthcare Products
Regulatory Agency
(MHRA)
Pangaea Group
Johnson & Johnson
International Safe
Transit Association
(ISTA)
PCCIG USA Branch, PDA
Eli Lilly
Talecris Biotherapuetics
Johnson & Johnson
Medical Products
EMD Serono
What's New for CC
Updated International Regulations
** A unique opportunity! Don't miss the pre-conference interactive workshop with Health Canada
to discuss updates to <0069>, implementation in practice and work through case studies of recent,
real audits and how to avoid them
** Across the globe, regulatory focus is shifting from GMP to GDP. Join the Panel Discussion on what
these developing GDP guidelines look like and what temperature control elements are included
** Learn about new Generic pharmaceutical regulations and the impact of pricing pressures on today's
direct distribution channels and product movement in the supply chain
Temperature Mapping & Data Monitoring
** Learn how J&J has designed temperature mapping studies and used the results for sourcing
multiple solutions for CRT and ambient products
** CRT and Ambient: Discuss what exactly are the defined temperature ranges and how companies are
developing aligned approaches and finding cost-effective solutions
'Family Feud' Game Show: How Much Do You Know About Your
Supply Chain and Quality Teams?
Survey says...! The "Family Feud" Panel Session will have Supply Chain and Quality teams face off - asking
questions about who knows more about the other's role and responsibilities. The more serious discussion to
follow will focus on how quality can be integrated into an organization and everyday logistics operations
Driving Quality into the Complete Supply Chain and the "Last Miles"
** Get up to speed on new PCCIG Technical Report 46 "Last Mile" and what developing industry best
practice are for ensuring product integrity to the patient
** Hear the wholesaler perspective on sharing stability data and collaborating with the
manufacturer to ensure supply chain and patient safety
Canadian Importation and Distribution Strategy
** Transport Canada will speak about current screening cargo guidelines and the new developing screening
cargo guidelines - and they want your input too!
** Join Canada Border Services, Health Canada and pharma manufacturer stakeholders to discuss
practical, collaborative measures that can be taken to ensure efficient importation of temperature sensitive
pharmaceuticals for distribution into Canada
** Talecris Biotherapeutics will discuss how to gain greater visibility in a distribution process by aligning
processes between shipper, freight forwarder, airline and 3PL
** Eli Lilly will talk about quality aspects of outsourcing distribution - how new distribution models can
benefit all stakeholders
Packaging Innovations
** Learn about a new statistical methodology that analyzes and compares temperature testing
profiles and performance between shipping systems
** Following regulations, many companies are re-qualifying packaging. Hear a new case study on
re-design temperature control packaging to demonstrate a qualified system to regulators
2 Register by December 17th to Save up to $1,100!
15-25°
Pre-Conference Workshops Tuesday, February 22, 2011
Dear Colleague,
So much is happening in the pharmaceutical cold and supply chain right now...
• GDP guidelines around the globe are being revised
• Transport Canada has announced new cargo screening guidelines
• PCCIG has published Technical Report 46 on the "Last Miles"
• You are getting more pressure to find cost-effective temperature control logistics, comply with Canadian regulations, while at the same time being asked by
HQ in another country to follow their regulations, use their solutions and adhere to their processes.
It’s these reasons, plus many more, why people are already signing up for the 9th annual Cold Chain & Temperature Management Summit taking place
again in Toronto. The industry has come to recognize the annual event as a meeting of thought leaders and uses the networking event to get up to speed
with current regulations and industry best practices.
With thanks for the Advisory Board, we've put together a brand new program, covering today's most pressing challenges in temperature control distribution
in Canada and internationally.
Don't miss the industry favorite meeting place for best practice discussions on temperature controlled, quality distribution! We look forward to
meeting you this February in Toronto and welcoming you to the IQPC 9th annual Cold Chain & Temperature Management Summit.
Sincerely,
Courtney Becker-James
Conference Director
IQPC
A
OR
Evolution of the Cool Chain Processes
9:45 am – 12:30 pm Registration at 9:00.
At this xx hour workshop, get a close understanding of Air Canada Cargo's
cool chain process. Learn first hand, what role an airline plays in the cool
chain process in the handling of both active packaging shipments and passive
packaging shipments. Communication and partnerships play a critical role in
maintaing the intergrity of time and temperature pharmaceutical shipments.
Learn through case studies, the challenges faced by key stakeholders
(including freight forwarders, suppliers, front line employees, and others) to deliver on their
individual roles and responsibilies.
Workshop Leaders:
Ameet Sareen, Air Canada Cargo
Trevor Howard, Air Canada Cargo
Choose from Workshop B or C 10:30am - 1:30pm Registration at 10:00am (Lunch will be provided)
GDP Transport for Room Temperature Products
The group will discuss solution options and criteria for implementing best practice
transportation systems and procedures that appropriately blend the needs of your
product, your business, and available services. We will also explore the
effectiveness of various choices through interactive active discussion and case
studies.
• Procedural options to effectively protect room temperature products from
temperatures encountered during transport
• Applying the available options in the most cost-effective way for your individual
supply or distribution chain
Workshop Leader: Karl Kussow, Manager, Quality, FedEx Custom Critical
The geographic location and size of Canada represent potentially huge challenges to
pharmaceutical companies in protecting their temperature sensitive shipments in an
increasing regulated environment. This workshop is designed identify key issues
surrounding these challenges and methods available to address 1) Canadian weather
extremes 2) Available 3rd party profiles and how they apply to the Canadian market
3)Mapping projects done for Canadian shipments 4) Applications of Canadian based
profiles in new designs and design tradeoffs
Workshop Leaders: Jean Bédard, CEO, Alternatives Technologies Pharma (ATP)
Anthony Alleva, Technical Services Manager, Cryopak
B Identifying Temperature Profiles to Address the
Challenges of the Canadian Market Shipping LanesC
Choose from Workshop D or E 2:00pm - 5:00pm Registration at 1:30pm
Leasing Programs: Evaluating Options for
Temperature Sensitive Pharmaceuticals
Leasing containers and boxes for shipping temperature sensitive pharmaceuticals is
certainly trending up. This workshop will explore the opportunities of sustainability,
supply chain quality and cost-savings realized through setting up an effective
leasing program between the shipper and leasing program partners.
Key Perspectives:
Active: Stephen Maietta, Director of Sales, Americas, Envirotainer
Passive: John Howe, CEO, Active CC Boxes
Regulations drive company strategies and the solutions they implement. If your
products are being distributed in Canada, you must have a complete understanding
of what 0069 entails and expects. This workshop will give participants a great
opportunity to have open dialogue with HC regarding updates to Regulation 0069
and work in small groups to dissect real case studies of inspections, audits and
temperature control challenges.
Workshop Leader: Sarah Skuce, Compliance Specialist, Health Canada
D Understanding and Discussing Health Canada 0069
RegulationsE
3Register by December 17th to Save up to $1,100!
Conference Day One
Wednesday, February 23, 2011
7:45 Registration & Coffee
8:40 Pharma IQ Welcome
8:45 Chairperson’s Opening Remarks
Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA
Branch, PDA
8:50 Revisions to Health Canada's GUI-0069: End to
End Control of Temperature Sensitive Products
Sarah Skuce, Compliance Specialist, Health Canada
9:30 Improving Temperature Controlled
Distribution Practices: A UK MHRA Regulatory
Perspective Parameters of Increasing
Regulatory Concern
Ian Holloway, Manager, Defective Medicines Report Centre,
Medicines and Healthcare Products Regulatory Agency
(MHRA)
1:30 PDA Report on Stability Testing Data to
Support Distribution and ‘In Use’ Conditions
Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA
Branch, PDA
2:15 Enhance Quality within the Supply Chain using
Information from Traceability, Pallet Hygiene
and Security
Jack Sparn, Chief Information Officer, iGPS
2:55 Afternoon Networking Break in Exhibit Hall
Track A: Temperature Mapping & Data Monitoring
ISTA Standard 20 for the Design and Qualification of
Insulated Shipping Containers
Edward A. Church, President, International Safe Transit Association
(ISTA)
A Case Study of Rental and Leasing Programs for
Small Package Shipping
John Howe, CEO, Active CC Boxes
3:40 Conducting an Ambient/Controlled Room
Temperature (CRT) Profiling Study
Alan J. Davis, Supply Chain Temperature Control Leader,
Johnson & Johnson
4:25 Panel Discussion: Standardizing Room
Temperature and Ambient Approaches
Panelists:
John Collins, Director, QA, Novartis Pharmaceuticals
Canada Inc
Sarah Skuce, Compliance Specialist, Health Canada
Alan J. Davis, Supply Chain Temperature Control Leader,
Johnson & Johnson
5:05 Closing Remarks and End of Day One
5:15 Networking Cocktail Reception in Exhibition Hall
Re-Design and Re-Qualification of Temperature
Control Packaging: Case Study
Patricia Hanlon, Senior Director, Business Development, Marken Ltd.
Analyzing and Comparing Temperature Testing
Profiles and the Performance Between Shippers
Paul Harber, Associate Engineering Consultant, Eli Lilly
Track B: Packaging Innovations
10:10 Morning Networking Break in Exhibit Hall
10:55 Comparing GDP Regulations Around the Globe
and Considerations for Temperature Control
Distribution
Moderator:
Allan Reynolds, Vice President, Industry & Member Relations,
Canadian Association for Pharmacy Distribution
Management (CAPDM)
Panelists:
Ian Holloway, Manager, Defective Medicines Report Centre,
Medicines and Healthcare Products Regulatory Agency
(MHRA)
Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA
Branch, PDA
Representative, Health Canada
11:35 New Generic Pharmaceuticals Regulations:
Impact to Distribution Channels in Canada
Joe Knott, Founder and President, Pangaea Group
12:15 Networking Luncheon
INTERNATIONAL REGULATIONSINTERNATIONAL REGULATIONS
4 Register by December 17th to Save up to $1,100!
To view full session abstracts, please visit www.ColdChainPharm.com
Concurrent sessions begin: Choose Track A or B
“An eye opener on several topics. I enjoyed both days and would recommend such an event to other colleagues.
Also, networking was great” - PM of Quality Assurance Compliance, Abbott Laboratories
Conference Day Two
Thursday, February 24, 2011
5
To view full session abstracts, please visit www.ColdChainPharm.com
Register by December 17th to Save up to $1,100!
“An outstanding compilation of speakers and topics, helping our industry to stay
on the cutting edge of technology and regulations” - Manager of Global Distribution, Biomereux
7:45 Registration & Coffee
8:15 Chairperson’s Opening Remarks
Jim Bacon, Senior Director, Global Demand Planning and
Customer Operations, Talecris Biotherapeutics
8:20 Opening Roundtable: Transport Canada’s New
Rules for Air Cargo
Jennifer Grandy, Chief, Program Design, Air Cargo Security,
Transport Canada
9:00 Importation of Temperature Sensitive
Pharmaceuticals into Canada
Mau'veen Dayrell-Johnson, Senior Officer, Trade Compliance,
Canada Border Services Agency
9:40 Panel Discussion A Collaborative Approach to
Efficient Importation and Distribution of
Temperature Controlled Pharmaceuticals into
Canada
Panelists:
Mau'veen Dayrell-Johnson, Senior Officer, Trade Compliance,
Canada Border Services
Sarah Skuce, Compliance Specialist, Health Canada
10:15 Morning Networking Break in Exhibit Hall
11:00 Gaining Visibility in the Cold Chain: Accessing
Data and Aligning Processes between Shipper,
Freight Forwarder, Airline, and 3PL
Jim Bacon, Senior Director, Global Demand Planning and
Customer Operations, Talecris Biotherapeutics
11:40 Distribution Model Case Study: Quality Issues
Surrounding Outsourcing Distribution
Sandra Usik, Associate Director, Regulatory Affairs & Quality,
Eli Lilly, Canada
12:20 Networking Luncheon
1:30 Considerations for Selecting 2-8°
Transportation Solutions for Distribution
within Canada
Silvia Castellarin, Manager, Transportation Canada, Johnson
& Johnson Medical Products
2:10 "Family Feud" - How Much Do You Know
About Your Supply Chain and Quality Teams?
During this session, Supply Chain and Quality will face off. Each
'family' or team will be surveyed questions about the other's
role, function and responsibilities. The purpose of the
questioning is to underline the knowledge gaps that exist
between the teams so organization can develop workable
solutions to bridge these gaps. The Panel Discussion to follow
will concentrate on how successfully integrate quality into
everyday logistics operations.
Quality Panelists:
Mandy Wagner, QA Project Manager, Merck Serono
Sandra Usik, Associate Director, Regulatory Affairs & Quality,
Eli Lilly, Canada
Dr. Mary Mazur-Melnyk, Chief Scientific Officer, Innovalinks
Quality Consultants
Supply Chain/Logistics Panelists:
Silvia Castellarin, Manager, Transportation Canada, Johnson
& Johnson Medical Products
Jas Kaloti, Logistics Supervisor, AstraZeneca
2:50 Networking Break In The Exhibit Hall
3:35 PCCIG Technical Report 46 "Last Mile": Best
Practices for Ensuring Product Integrity to the
Patient
Anthony (TJ) Rizzo, Strategic Account Engineer, Cold Chain
Technologies & Member, PCCIG TR 46 Task Team
4:15 Wholesaler Perspective: Communicating
Allowable Excursion and "Out of Storage'
Temperature Data
Claude Jolicoeur, Director, Regulatory Affairs, Corporate GMP
Officer, McKesson Canada
4:55 Closing Remarks and End of Conference
Who Will Attend the Cold Chain & Temperature Management Summit?
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 Care Stores
3% Public Health Program Administration
2% Medical Equipment and Supplies Manufacturing
16% Other
CANADIAN IMPORTATION
AND DISTRIBUTION STRATEGY
DRIVING QUALITY INTO THE COMPLETE
SUPPLY CHAIN AND THE "LAST MILES"
About Our Sponsors
Marken
Website: www.marken.com
Marken is one of the leading suppliers of cold-chain
logistics for clinical supplies worldwide. Temperature-control during the handling, storage
and 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 to
sites. We provide:
• Global distribution of temperature controlled trial medication, vaccines & CTM
• Temperature control monitoring for ambient, 2-8C and frozen products to maintain
integrity of supplies
• Advice on packaging materials and provision of containers for global transportation
• Refrigerated trucking services
• Customs brokerage accelerating clearance
Active CC Boxes
Website: www.activeccboxes.com
Active CC Boxes, LLC designs and manufactures high-tech
shipping containers for shipping temperature sensitive
pharmaceutical and biotech products. The Company rents
Kodiak™ containers by the trip or leases them on long term leases
and maintains a depot system in key locations to eliminate or reduce
return logistics costs for the containers.
Envirotainer
Website: www.envirotainer.com
Pioneer 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, food and
high-tech industries benefit from the combination of advanced container technology,
extensive cold chain management services and a global network of service partners, airlines
and forwarders - providing a unique one-way leasing service. 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 customers in transport validations
and risk management.
Kuehne + Nagel
Website: www.kn-portal.com
Kuehne + Nagel is a world leader in providing integrated logistics services for
manufacturers of pharmaceuticals, biotechnology, medical devices and other healthcare
products. Our services and solutions are designed to meet the exacting operational
requirements of this regulated environment (GxP). We do significant business with some of
the world’s leading pharmaceutical/healthcare companies, as well as other select customers
in the 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 to optimally manage healthcare firms' complex global procurement
and supply chain processes. We will assess current customer supply chain processes against
standard and industry benchmarks to identify areas for improvement. Using advanced
analysis and modeling tools, alternate models are evaluated against identified cost and
service objectives to arrive at the optimal solution.
Air Canada:
Website: http://www.aircanada.com/cargo/en/
solutions/ac_cool.html
Air Canada is Canada's largest full-service airline and the largest provider of scheduled
passenger services in the Canadian market, the Canada-U.S. transborder market and in the
international market to and from Canada. Together with our regional partner Jazz, Air
Canada serves over 32 million customers annually and provides direct passenger service to
over 170 destinations on five continents. Air Canada is a founding member of Star
Alliance™, the world's most comprehensive air transportation network.
Air Canada's cargo services division (doing business as "Air Canada Cargo") provides direct
cargo services to over 150 Canadian and international destinations and has sales
representation in over 50 countries. Air Canada Cargo is Canada's largest provider of air
cargo services, which are provided on domestic and U.S. transborder flights and on
international cargo services on routes between Canada and major markets in Europe, Asia,
South America and Australia.
FedEx Custom Critical
Website: customcritical.fedex.com/coldchain
FedEx Custom Critical offers a complete array of surface
and air solutions to safely and securely ship temperature-sensitive products. You can choose
from exclusive-use vehicles with temperature controlled cargo boxes to airfreight solutions
utilizing temperature-controlled air containers. With our Temp-Assure Validated services,
you also receive hard-copy documentation of the temperature inside the vehicle or
container throughout transport. This assists our pharmaceutical customers with their
compliance needs through a documented audit trail of their products’ temperature
throughout the shipping process. FedEx Custom Critical services are available 24/7/365 with
surface solutions throughout the U.S. and Canada and air solutions across the globe.
iGPS
Website: www.igps.net
iGPS operates the world’s first pallet rental service providing
all-plastic pallets with embedded RFID tags. Its highly
engineered all-plastic pallets are “lighter, stronger, safer and
greener” than platforms made of wood. iGPS recently introduced its iGPS Bios™ program,
specifically designed for the unique needs of the Pharmaceutical industry. iGPS bios pallets
are hand selected to ensure pristine quality, then washed and sanitized and, finally, enclosed
in protective wrapping to maintain their hygienic condition. Manufacturers that utilize the
iGPS bios program can be confident that the pallets they receive are free of paint,
pathogens and toxic pesticides and fungicides, like TBA.
Minnesota Thermal Science, LLC
Website: www.goldenhourtechnology.com
Minnesota Thermal Science, LLC develops unique storage
and shipping systems that address the challenges of maintaining
constant and predictable temperatures when transporting temperature sensitive medical
materials. Founded in 2004 following an industry wide search by the Walter Reed Army
Institute of Research for a more effective combat environment container, MTS has continued
to apply its technology to handle other important medical materials including all types of
biomaterials and pharmaceuticals that require controlled temperatures Its patent pending
Golden Hour® Technology, winner of a "U.S. Army Greatest Inventions" award, is credited
with saving soldier's lives on the battlefield and with revolutionizing the methods used for
distributing temperature sensitive medical supplies.
Cryopak
Website: www.cryopak.com
Cryopak (a TCP Reliable Company), specializes in the
field of temperature controlled packaging and services
including package design, qualification, testing
manufacturing insulated shippers, refrigerants, phase change materials and temperature
monitors. All services are provided in strict conformance with ISO 9001:2000, ISTA and ASTM
test methodology, and FDA good manufacturing practices. TCP maintains facilities in Quebec,
British Columbia, New Jersey and France.
World Courier of Canada Ltd.
Website: www.worldcourier.com
World 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 same
operating standards dedicated to treating every shipment on an individual, priority basis.
World Courier is utilized in approximately 80% of the world’s clinical trials requiring the use of
a specialty courier. With experience in managing the logistics of over 7,500 clinical trials
worldwide, we are the acknowledged experts in handling temperature-sensitive specimen
and drug shipments.
Berlinger
Website: www.berlinger.com
Innovation has propelled the Berlinger Company
through the past 150 years. Our customer base
challenges us to build intelligent decision making tools for the entire cold chain process. Now
a temperature sensitive product can be monitored through 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. We
welcome your next temperature monitoring challenge.
Sensitech
Website: www.sensitech.com
Sensitech - The leading provider of cold chain visibility
solutions that enable our customers to track and monitor assets
across the supply chain, protecting the quality, efficacy, and
integrity of their temperature-sensitive products. Our product
portfolio includes comprehensive analytic services, enterprise software systems and validated
data acquisition devices. We address our customers’ most complex perishable cold chain
problems and deliver powerful insights that drive measurable process improvement. Sensitech
supports cold chain monitoring programs in 18 of the top 20 multi-national pharmaceutical
companies and 9 of the top 10 biopharmaceutical companies. Sensitech is a business unit of
Carrier Corp.
Skelton Truck Lines
Website: www.skeltontruck.com
Skelton has provided refrigerated services for 28 years to
Pharmaceutical/Biological companies. We partner with
customers to ensure we maintain product integrity through out the cold chain link. 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. Our investment in assets, people
and training have provided our customers with a Tried, Tested and Proven solution that meets
and exceeds Health Canada 0069 regulations.
American Thermal Instruments, Inc.
Website: www.americanthermal.com
Founded in 1981, American Thermal Instruments,
Inc. has been exceeding customer expectations as an
international organization specializing in temperature
monitoring solutions. ATI temperature monitoring solutions include liquid crystal
thermometers, irreversible temperature indicators, color changing products, Log-ic® electronic
content monitoring, and microencapsulation services. Our facility is ISO 9001 certified, FDA
registered, and operates under cGMP. ATI manufactures non toxic, nonbreakable, reusable,
disposable and easy-to-read thermometers for diverse markets and applications. ATI acts as a
distribution arm for the Log-ic® Temperature Tracking System.
The Log-ic® system is revolutionizing the Cold Chain, giving customers the capability to track
and trace temperature history of shipments.
ATS Healthcare
Website: www.ats.ca
ATS Healthcare offers a broad range of transportation services
including temperature management offerings specifically designed
to meet the requirements of Health Canada guideline 0069. ATS is
focused on providing solutions within Canada for the healthcare
industry and as such operates a network of branches coast to coast and a fleet of
temperature controlled vehicles.
6 Register by December 17th to Save up to $1,100!
Twitter: www.twitter.com/ColdChainPharma
Facebook: Cold Chain & Temperature Management
LinkedIn: Cold Chain Distribution for Pharmaceuticals
Blogger: www.pharmacoldchain.blogspot.com
Visit our Cold Chain Resource Center at www.ColdChainPharm.com for podcasts,
speaker interviews, articles and more!
Connect With Our Cold Chain Communities!
Sponsorships and exhibits are excellent
opportunities for your company to showcase its
products and services to high-level, targeted
decision-makers attending the 9th Cold Chain &
Temperature Management Summit. IQPC and
Pharma IQ help companies like yours achieve
important sales, marketing and branding
objectives by setting aside a limited number of
event sponsorships and exhibit spaces – all of
which are tailored to assist your organization in
creating a platform to maximize its exposure at
the event.
For more information on sponsoring or
exhibiting at the 9th Cold Chain & Temperature
Management Summit, please contact Thomas
Boccard at 646-253-5517 or
sponsorship@iqpc.com.
Pharma IQ, the pharmaceutical division of
IQPC, provides a forum to address the critical
issues facing the pharmaceutical industry
today. Pharma IQ utilizes workshop,
conference and training course formats to
facilitate a learning environment for
pharmaceutical professionals working in all
areas of drug development: from Discovery
to Post-marketing.
Visit www.iqpc.com to see what other
exciting and information-packed conferences
and webinars are being offered by the
International Quality & Productivity Center.
About the Organizer:
Westin Prince, Toronto
900 York Mills Road
Toronto, ON M3B 3H2, Canada
Phone: (416) 444-2511
Website: www.westinprincetoronto.com
Sponsorship and Exhibition
Opportunities
Prices are in Canadian dollars and are subject to a 13%
HST.
A $99 processing charge will be assessed to all
registrations not accompanied by credit card payment
at the time of registration.
MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC
* CT residents or people employed in the state of CT
must add 6% 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:
Bank-HSBC
Account # 002-385-007-001
SWIFT Code HKBCCATT
Reference: Please include the name of the attendee(s) and the event
number: 11165.005
Payment Policy: Payment is due in full at the time of registration and
includes lunches and refreshment. Your registration will not be confirmed
until payment is received and may be subject to cancellation.
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.
©2010 IQPC. All Rights Reserved. The format, design, content and arrangement
of this brochure constitute a trademark of IQPC. Unauthorized reproduction will
be actionable under the Lanham Act and common law principles.
Register by Register by
December 17, 2010 January 28, 2011 Standard Price
Conference Only (save $1,000) (save $500)
$999 $1,499 $1,999
Conference + 1 workshop (save $1,000) (save $500)
$1,548 $2,048 $2,548
Conference + 2 workshops (save $1,100) (save $600)
$1,997 $2,497 $3,097
Workshop(s) $549 each $549 each $549 each
Industry Pricing
Registration Information
Venue:
For accommodations information, please visit the event website at www.ColdChainPharm.com.
Accommodations:
7Register by December 17th to Save up to $1,100!
Register by Register by
December 17, 2010 January 28, 2011 Standard Price
Conference Only (save $1,000) (save $600)
$2,599 $2,999 $3,599
Conference + 1 workshop (save $1,000) (save $600)
$3,148 $3,548 $4,148
Conference + 2 workshops (save $1,100) (save $700)
$3,597 $3,997 $4,697
Workshop(s) $549 each $549 each $549 each
Other Pricing
Government agencies, Pharmacies and Hospitals are eligible for a 50% discount off standard Industry pricing
Industry pricing is eligible for manufacturers of finished
bio-pharmaceutical products, IMPs, drug components or
medical devices.
11165.005
International Quality & Productivity Center
535 5th Avenue, 8th Floor
New York, NY 10017YES! Please
register me
for:
See page 7 for pricing details
❑ Main Conference Only
REGISTRATION CARD
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__________________________________________________________________
❑ Please keep me informed via email about this and other related events.
❑ Check enclosed for $_________ (Payable to IQPC)
❑ Charge my __AmEx __Visa __Mastercard __Discover
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Details for making payment via EFT or wire transfer can be found on
preceding page.
❑ I cannot attend, but please keep me informed of all future events.
5 EASY WAYS TO REGISTER:
3
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Web: www.ColdChainPharm.com/Quality
Call: 1-800-882-8684
Email: info@iqpc.com
Fax: 1-646-378-6025
Mail: IQPC
535 5th Avenue, 8th Floor,
New York, NY 10017
❑ Workshop(s)
❑ A ❑ B ❑ C ❑ D ❑ E
CC
Presents the
CC
February 22 - 24, 2011
Westin Prince Hotel, Toronto, Ontario, Canada
Sponsored By:

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Cold Chain & Temperature Management

  • 1. ✔ Sit down with Health Canada to discuss the updates to <0069> (due out by early 2011) and understand what prompts inspections and what they look for during audits ✔ Understand new PCCIG guidance around Risk Management, Stability Data during 'In transit' and Technical Report 46 on 'Last Miles' ✔ Improve quality throughout your supply chain organization by collaborating with logistics teams and structuring your organization in a way that embeds QA into everyday logistics ✔ Ensure compliance by understanding and comparing GDP updated regulations around the globe and considerations for temperature control distribution ✔ Define a CRT or Ambient approach to temperature mapping study, route profiling and risk assessment for specific channels ✔ Hear the wholesaler perspective on sharing stability data and collaborating with the manufacturer to ensure supply chain and patient safety Presents the CC February 22 - 24, 2011 Westin Prince Hotel, Toronto, Ontario, Canada www.ColdChainPharm.com/Quality Sponsored By: Join 200+ of your industry colleagues at the only Canadian event for cold chain and temperature controlled pharmaceuticals. Attend to: Hear from experts in the industry: Health Canada Transport Canada Canada Border Services Agency Eli Lilly, Canada Canadian Association for Pharmacy Distribution Management (CAPDM) McKesson Canada Medicines and Healthcare Products Regulatory Agency (MHRA) Pangaea Group Johnson & Johnson International Safe Transit Association (ISTA) PCCIG USA Branch, PDA Eli Lilly Talecris Biotherapuetics Johnson & Johnson Medical Products EMD Serono
  • 2. What's New for CC Updated International Regulations ** A unique opportunity! Don't miss the pre-conference interactive workshop with Health Canada to discuss updates to <0069>, implementation in practice and work through case studies of recent, real audits and how to avoid them ** Across the globe, regulatory focus is shifting from GMP to GDP. Join the Panel Discussion on what these developing GDP guidelines look like and what temperature control elements are included ** Learn about new Generic pharmaceutical regulations and the impact of pricing pressures on today's direct distribution channels and product movement in the supply chain Temperature Mapping & Data Monitoring ** Learn how J&J has designed temperature mapping studies and used the results for sourcing multiple solutions for CRT and ambient products ** CRT and Ambient: Discuss what exactly are the defined temperature ranges and how companies are developing aligned approaches and finding cost-effective solutions 'Family Feud' Game Show: How Much Do You Know About Your Supply Chain and Quality Teams? Survey says...! The "Family Feud" Panel Session will have Supply Chain and Quality teams face off - asking questions about who knows more about the other's role and responsibilities. The more serious discussion to follow will focus on how quality can be integrated into an organization and everyday logistics operations Driving Quality into the Complete Supply Chain and the "Last Miles" ** Get up to speed on new PCCIG Technical Report 46 "Last Mile" and what developing industry best practice are for ensuring product integrity to the patient ** Hear the wholesaler perspective on sharing stability data and collaborating with the manufacturer to ensure supply chain and patient safety Canadian Importation and Distribution Strategy ** Transport Canada will speak about current screening cargo guidelines and the new developing screening cargo guidelines - and they want your input too! ** Join Canada Border Services, Health Canada and pharma manufacturer stakeholders to discuss practical, collaborative measures that can be taken to ensure efficient importation of temperature sensitive pharmaceuticals for distribution into Canada ** Talecris Biotherapeutics will discuss how to gain greater visibility in a distribution process by aligning processes between shipper, freight forwarder, airline and 3PL ** Eli Lilly will talk about quality aspects of outsourcing distribution - how new distribution models can benefit all stakeholders Packaging Innovations ** Learn about a new statistical methodology that analyzes and compares temperature testing profiles and performance between shipping systems ** Following regulations, many companies are re-qualifying packaging. Hear a new case study on re-design temperature control packaging to demonstrate a qualified system to regulators 2 Register by December 17th to Save up to $1,100! 15-25°
  • 3. Pre-Conference Workshops Tuesday, February 22, 2011 Dear Colleague, So much is happening in the pharmaceutical cold and supply chain right now... • GDP guidelines around the globe are being revised • Transport Canada has announced new cargo screening guidelines • PCCIG has published Technical Report 46 on the "Last Miles" • You are getting more pressure to find cost-effective temperature control logistics, comply with Canadian regulations, while at the same time being asked by HQ in another country to follow their regulations, use their solutions and adhere to their processes. It’s these reasons, plus many more, why people are already signing up for the 9th annual Cold Chain & Temperature Management Summit taking place again in Toronto. The industry has come to recognize the annual event as a meeting of thought leaders and uses the networking event to get up to speed with current regulations and industry best practices. With thanks for the Advisory Board, we've put together a brand new program, covering today's most pressing challenges in temperature control distribution in Canada and internationally. Don't miss the industry favorite meeting place for best practice discussions on temperature controlled, quality distribution! We look forward to meeting you this February in Toronto and welcoming you to the IQPC 9th annual Cold Chain & Temperature Management Summit. Sincerely, Courtney Becker-James Conference Director IQPC A OR Evolution of the Cool Chain Processes 9:45 am – 12:30 pm Registration at 9:00. At this xx hour workshop, get a close understanding of Air Canada Cargo's cool chain process. Learn first hand, what role an airline plays in the cool chain process in the handling of both active packaging shipments and passive packaging shipments. Communication and partnerships play a critical role in maintaing the intergrity of time and temperature pharmaceutical shipments. Learn through case studies, the challenges faced by key stakeholders (including freight forwarders, suppliers, front line employees, and others) to deliver on their individual roles and responsibilies. Workshop Leaders: Ameet Sareen, Air Canada Cargo Trevor Howard, Air Canada Cargo Choose from Workshop B or C 10:30am - 1:30pm Registration at 10:00am (Lunch will be provided) GDP Transport for Room Temperature Products The group will discuss solution options and criteria for implementing best practice transportation systems and procedures that appropriately blend the needs of your product, your business, and available services. We will also explore the effectiveness of various choices through interactive active discussion and case studies. • Procedural options to effectively protect room temperature products from temperatures encountered during transport • Applying the available options in the most cost-effective way for your individual supply or distribution chain Workshop Leader: Karl Kussow, Manager, Quality, FedEx Custom Critical The geographic location and size of Canada represent potentially huge challenges to pharmaceutical companies in protecting their temperature sensitive shipments in an increasing regulated environment. This workshop is designed identify key issues surrounding these challenges and methods available to address 1) Canadian weather extremes 2) Available 3rd party profiles and how they apply to the Canadian market 3)Mapping projects done for Canadian shipments 4) Applications of Canadian based profiles in new designs and design tradeoffs Workshop Leaders: Jean Bédard, CEO, Alternatives Technologies Pharma (ATP) Anthony Alleva, Technical Services Manager, Cryopak B Identifying Temperature Profiles to Address the Challenges of the Canadian Market Shipping LanesC Choose from Workshop D or E 2:00pm - 5:00pm Registration at 1:30pm Leasing Programs: Evaluating Options for Temperature Sensitive Pharmaceuticals Leasing containers and boxes for shipping temperature sensitive pharmaceuticals is certainly trending up. This workshop will explore the opportunities of sustainability, supply chain quality and cost-savings realized through setting up an effective leasing program between the shipper and leasing program partners. Key Perspectives: Active: Stephen Maietta, Director of Sales, Americas, Envirotainer Passive: John Howe, CEO, Active CC Boxes Regulations drive company strategies and the solutions they implement. If your products are being distributed in Canada, you must have a complete understanding of what 0069 entails and expects. This workshop will give participants a great opportunity to have open dialogue with HC regarding updates to Regulation 0069 and work in small groups to dissect real case studies of inspections, audits and temperature control challenges. Workshop Leader: Sarah Skuce, Compliance Specialist, Health Canada D Understanding and Discussing Health Canada 0069 RegulationsE 3Register by December 17th to Save up to $1,100!
  • 4. Conference Day One Wednesday, February 23, 2011 7:45 Registration & Coffee 8:40 Pharma IQ Welcome 8:45 Chairperson’s Opening Remarks Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA Branch, PDA 8:50 Revisions to Health Canada's GUI-0069: End to End Control of Temperature Sensitive Products Sarah Skuce, Compliance Specialist, Health Canada 9:30 Improving Temperature Controlled Distribution Practices: A UK MHRA Regulatory Perspective Parameters of Increasing Regulatory Concern Ian Holloway, Manager, Defective Medicines Report Centre, Medicines and Healthcare Products Regulatory Agency (MHRA) 1:30 PDA Report on Stability Testing Data to Support Distribution and ‘In Use’ Conditions Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA Branch, PDA 2:15 Enhance Quality within the Supply Chain using Information from Traceability, Pallet Hygiene and Security Jack Sparn, Chief Information Officer, iGPS 2:55 Afternoon Networking Break in Exhibit Hall Track A: Temperature Mapping & Data Monitoring ISTA Standard 20 for the Design and Qualification of Insulated Shipping Containers Edward A. Church, President, International Safe Transit Association (ISTA) A Case Study of Rental and Leasing Programs for Small Package Shipping John Howe, CEO, Active CC Boxes 3:40 Conducting an Ambient/Controlled Room Temperature (CRT) Profiling Study Alan J. Davis, Supply Chain Temperature Control Leader, Johnson & Johnson 4:25 Panel Discussion: Standardizing Room Temperature and Ambient Approaches Panelists: John Collins, Director, QA, Novartis Pharmaceuticals Canada Inc Sarah Skuce, Compliance Specialist, Health Canada Alan J. Davis, Supply Chain Temperature Control Leader, Johnson & Johnson 5:05 Closing Remarks and End of Day One 5:15 Networking Cocktail Reception in Exhibition Hall Re-Design and Re-Qualification of Temperature Control Packaging: Case Study Patricia Hanlon, Senior Director, Business Development, Marken Ltd. Analyzing and Comparing Temperature Testing Profiles and the Performance Between Shippers Paul Harber, Associate Engineering Consultant, Eli Lilly Track B: Packaging Innovations 10:10 Morning Networking Break in Exhibit Hall 10:55 Comparing GDP Regulations Around the Globe and Considerations for Temperature Control Distribution Moderator: Allan Reynolds, Vice President, Industry & Member Relations, Canadian Association for Pharmacy Distribution Management (CAPDM) Panelists: Ian Holloway, Manager, Defective Medicines Report Centre, Medicines and Healthcare Products Regulatory Agency (MHRA) Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA Branch, PDA Representative, Health Canada 11:35 New Generic Pharmaceuticals Regulations: Impact to Distribution Channels in Canada Joe Knott, Founder and President, Pangaea Group 12:15 Networking Luncheon INTERNATIONAL REGULATIONSINTERNATIONAL REGULATIONS 4 Register by December 17th to Save up to $1,100! To view full session abstracts, please visit www.ColdChainPharm.com Concurrent sessions begin: Choose Track A or B “An eye opener on several topics. I enjoyed both days and would recommend such an event to other colleagues. Also, networking was great” - PM of Quality Assurance Compliance, Abbott Laboratories
  • 5. Conference Day Two Thursday, February 24, 2011 5 To view full session abstracts, please visit www.ColdChainPharm.com Register by December 17th to Save up to $1,100! “An outstanding compilation of speakers and topics, helping our industry to stay on the cutting edge of technology and regulations” - Manager of Global Distribution, Biomereux 7:45 Registration & Coffee 8:15 Chairperson’s Opening Remarks Jim Bacon, Senior Director, Global Demand Planning and Customer Operations, Talecris Biotherapeutics 8:20 Opening Roundtable: Transport Canada’s New Rules for Air Cargo Jennifer Grandy, Chief, Program Design, Air Cargo Security, Transport Canada 9:00 Importation of Temperature Sensitive Pharmaceuticals into Canada Mau'veen Dayrell-Johnson, Senior Officer, Trade Compliance, Canada Border Services Agency 9:40 Panel Discussion A Collaborative Approach to Efficient Importation and Distribution of Temperature Controlled Pharmaceuticals into Canada Panelists: Mau'veen Dayrell-Johnson, Senior Officer, Trade Compliance, Canada Border Services Sarah Skuce, Compliance Specialist, Health Canada 10:15 Morning Networking Break in Exhibit Hall 11:00 Gaining Visibility in the Cold Chain: Accessing Data and Aligning Processes between Shipper, Freight Forwarder, Airline, and 3PL Jim Bacon, Senior Director, Global Demand Planning and Customer Operations, Talecris Biotherapeutics 11:40 Distribution Model Case Study: Quality Issues Surrounding Outsourcing Distribution Sandra Usik, Associate Director, Regulatory Affairs & Quality, Eli Lilly, Canada 12:20 Networking Luncheon 1:30 Considerations for Selecting 2-8° Transportation Solutions for Distribution within Canada Silvia Castellarin, Manager, Transportation Canada, Johnson & Johnson Medical Products 2:10 "Family Feud" - How Much Do You Know About Your Supply Chain and Quality Teams? During this session, Supply Chain and Quality will face off. Each 'family' or team will be surveyed questions about the other's role, function and responsibilities. The purpose of the questioning is to underline the knowledge gaps that exist between the teams so organization can develop workable solutions to bridge these gaps. The Panel Discussion to follow will concentrate on how successfully integrate quality into everyday logistics operations. Quality Panelists: Mandy Wagner, QA Project Manager, Merck Serono Sandra Usik, Associate Director, Regulatory Affairs & Quality, Eli Lilly, Canada Dr. Mary Mazur-Melnyk, Chief Scientific Officer, Innovalinks Quality Consultants Supply Chain/Logistics Panelists: Silvia Castellarin, Manager, Transportation Canada, Johnson & Johnson Medical Products Jas Kaloti, Logistics Supervisor, AstraZeneca 2:50 Networking Break In The Exhibit Hall 3:35 PCCIG Technical Report 46 "Last Mile": Best Practices for Ensuring Product Integrity to the Patient Anthony (TJ) Rizzo, Strategic Account Engineer, Cold Chain Technologies & Member, PCCIG TR 46 Task Team 4:15 Wholesaler Perspective: Communicating Allowable Excursion and "Out of Storage' Temperature Data Claude Jolicoeur, Director, Regulatory Affairs, Corporate GMP Officer, McKesson Canada 4:55 Closing Remarks and End of Conference Who Will Attend the Cold Chain & Temperature Management Summit? 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 Care Stores 3% Public Health Program Administration 2% Medical Equipment and Supplies Manufacturing 16% Other CANADIAN IMPORTATION AND DISTRIBUTION STRATEGY DRIVING QUALITY INTO THE COMPLETE SUPPLY CHAIN AND THE "LAST MILES"
  • 6. About Our Sponsors Marken Website: www.marken.com Marken is one of the leading suppliers of cold-chain logistics for clinical supplies worldwide. Temperature-control during the handling, storage and 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 to sites. We provide: • Global distribution of temperature controlled trial medication, vaccines & CTM • Temperature control monitoring for ambient, 2-8C and frozen products to maintain integrity of supplies • Advice on packaging materials and provision of containers for global transportation • Refrigerated trucking services • Customs brokerage accelerating clearance Active CC Boxes Website: www.activeccboxes.com Active CC Boxes, LLC designs and manufactures high-tech shipping containers for shipping temperature sensitive pharmaceutical and biotech products. The Company rents Kodiak™ containers by the trip or leases them on long term leases and maintains a depot system in key locations to eliminate or reduce return logistics costs for the containers. Envirotainer Website: www.envirotainer.com Pioneer 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, food and high-tech industries benefit from the combination of advanced container technology, extensive cold chain management services and a global network of service partners, airlines and forwarders - providing a unique one-way leasing service. 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 customers in transport validations and risk management. Kuehne + Nagel Website: www.kn-portal.com Kuehne + Nagel is a world leader in providing integrated logistics services for manufacturers of pharmaceuticals, biotechnology, medical devices and other healthcare products. Our services and solutions are designed to meet the exacting operational requirements of this regulated environment (GxP). We do significant business with some of the world’s leading pharmaceutical/healthcare companies, as well as other select customers in the 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 to optimally manage healthcare firms' complex global procurement and supply chain processes. We will assess current customer supply chain processes against standard and industry benchmarks to identify areas for improvement. Using advanced analysis and modeling tools, alternate models are evaluated against identified cost and service objectives to arrive at the optimal solution. Air Canada: Website: http://www.aircanada.com/cargo/en/ solutions/ac_cool.html Air Canada is Canada's largest full-service airline and the largest provider of scheduled passenger services in the Canadian market, the Canada-U.S. transborder market and in the international market to and from Canada. Together with our regional partner Jazz, Air Canada serves over 32 million customers annually and provides direct passenger service to over 170 destinations on five continents. Air Canada is a founding member of Star Alliance™, the world's most comprehensive air transportation network. Air Canada's cargo services division (doing business as "Air Canada Cargo") provides direct cargo services to over 150 Canadian and international destinations and has sales representation in over 50 countries. Air Canada Cargo is Canada's largest provider of air cargo services, which are provided on domestic and U.S. transborder flights and on international cargo services on routes between Canada and major markets in Europe, Asia, South America and Australia. FedEx Custom Critical Website: customcritical.fedex.com/coldchain FedEx Custom Critical offers a complete array of surface and air solutions to safely and securely ship temperature-sensitive products. You can choose from exclusive-use vehicles with temperature controlled cargo boxes to airfreight solutions utilizing temperature-controlled air containers. With our Temp-Assure Validated services, you also receive hard-copy documentation of the temperature inside the vehicle or container throughout transport. This assists our pharmaceutical customers with their compliance needs through a documented audit trail of their products’ temperature throughout the shipping process. FedEx Custom Critical services are available 24/7/365 with surface solutions throughout the U.S. and Canada and air solutions across the globe. iGPS Website: www.igps.net iGPS operates the world’s first pallet rental service providing all-plastic pallets with embedded RFID tags. Its highly engineered all-plastic pallets are “lighter, stronger, safer and greener” than platforms made of wood. iGPS recently introduced its iGPS Bios™ program, specifically designed for the unique needs of the Pharmaceutical industry. iGPS bios pallets are hand selected to ensure pristine quality, then washed and sanitized and, finally, enclosed in protective wrapping to maintain their hygienic condition. Manufacturers that utilize the iGPS bios program can be confident that the pallets they receive are free of paint, pathogens and toxic pesticides and fungicides, like TBA. Minnesota Thermal Science, LLC Website: www.goldenhourtechnology.com Minnesota Thermal Science, LLC develops unique storage and shipping systems that address the challenges of maintaining constant and predictable temperatures when transporting temperature sensitive medical materials. Founded in 2004 following an industry wide search by the Walter Reed Army Institute of Research for a more effective combat environment container, MTS has continued to apply its technology to handle other important medical materials including all types of biomaterials and pharmaceuticals that require controlled temperatures Its patent pending Golden Hour® Technology, winner of a "U.S. Army Greatest Inventions" award, is credited with saving soldier's lives on the battlefield and with revolutionizing the methods used for distributing temperature sensitive medical supplies. Cryopak Website: www.cryopak.com Cryopak (a TCP Reliable Company), specializes in the field of temperature controlled packaging and services including package design, qualification, testing manufacturing insulated shippers, refrigerants, phase change materials and temperature monitors. All services are provided in strict conformance with ISO 9001:2000, ISTA and ASTM test methodology, and FDA good manufacturing practices. TCP maintains facilities in Quebec, British Columbia, New Jersey and France. World Courier of Canada Ltd. Website: www.worldcourier.com World 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 same operating standards dedicated to treating every shipment on an individual, priority basis. World Courier is utilized in approximately 80% of the world’s clinical trials requiring the use of a specialty courier. With experience in managing the logistics of over 7,500 clinical trials worldwide, we are the acknowledged experts in handling temperature-sensitive specimen and drug shipments. Berlinger Website: www.berlinger.com Innovation has propelled the Berlinger Company through the past 150 years. Our customer base challenges us to build intelligent decision making tools for the entire cold chain process. Now a temperature sensitive product can be monitored through 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. We welcome your next temperature monitoring challenge. Sensitech Website: www.sensitech.com Sensitech - The leading provider of cold chain visibility solutions that enable our customers to track and monitor assets across the supply chain, protecting the quality, efficacy, and integrity of their temperature-sensitive products. Our product portfolio includes comprehensive analytic services, enterprise software systems and validated data acquisition devices. We address our customers’ most complex perishable cold chain problems and deliver powerful insights that drive measurable process improvement. Sensitech supports cold chain monitoring programs in 18 of the top 20 multi-national pharmaceutical companies and 9 of the top 10 biopharmaceutical companies. Sensitech is a business unit of Carrier Corp. Skelton Truck Lines Website: www.skeltontruck.com Skelton has provided refrigerated services for 28 years to Pharmaceutical/Biological companies. We partner with customers to ensure we maintain product integrity through out the cold chain link. 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. Our investment in assets, people and training have provided our customers with a Tried, Tested and Proven solution that meets and exceeds Health Canada 0069 regulations. American Thermal Instruments, Inc. Website: www.americanthermal.com Founded in 1981, American Thermal Instruments, Inc. has been exceeding customer expectations as an international organization specializing in temperature monitoring solutions. ATI temperature monitoring solutions include liquid crystal thermometers, irreversible temperature indicators, color changing products, Log-ic® electronic content monitoring, and microencapsulation services. Our facility is ISO 9001 certified, FDA registered, and operates under cGMP. ATI manufactures non toxic, nonbreakable, reusable, disposable and easy-to-read thermometers for diverse markets and applications. ATI acts as a distribution arm for the Log-ic® Temperature Tracking System. The Log-ic® system is revolutionizing the Cold Chain, giving customers the capability to track and trace temperature history of shipments. ATS Healthcare Website: www.ats.ca ATS Healthcare offers a broad range of transportation services including temperature management offerings specifically designed to meet the requirements of Health Canada guideline 0069. ATS is focused on providing solutions within Canada for the healthcare industry and as such operates a network of branches coast to coast and a fleet of temperature controlled vehicles. 6 Register by December 17th to Save up to $1,100!
  • 7. Twitter: www.twitter.com/ColdChainPharma Facebook: Cold Chain & Temperature Management LinkedIn: Cold Chain Distribution for Pharmaceuticals Blogger: www.pharmacoldchain.blogspot.com Visit our Cold Chain Resource Center at www.ColdChainPharm.com for podcasts, speaker interviews, articles and more! Connect With Our Cold Chain Communities! Sponsorships and exhibits are excellent opportunities for your company to showcase its products and services to high-level, targeted decision-makers attending the 9th Cold Chain & Temperature Management Summit. IQPC and Pharma IQ help companies like yours achieve important sales, marketing and branding objectives by setting aside a limited number of event sponsorships and exhibit spaces – all of which are tailored to assist your organization in creating a platform to maximize its exposure at the event. For more information on sponsoring or exhibiting at the 9th Cold Chain & Temperature Management Summit, please contact Thomas Boccard at 646-253-5517 or sponsorship@iqpc.com. Pharma IQ, the pharmaceutical division of IQPC, provides a forum to address the critical issues facing the pharmaceutical industry today. Pharma IQ utilizes workshop, conference and training course formats to facilitate a learning environment for pharmaceutical professionals working in all areas of drug development: from Discovery to Post-marketing. Visit www.iqpc.com to see what other exciting and information-packed conferences and webinars are being offered by the International Quality & Productivity Center. About the Organizer: Westin Prince, Toronto 900 York Mills Road Toronto, ON M3B 3H2, Canada Phone: (416) 444-2511 Website: www.westinprincetoronto.com Sponsorship and Exhibition Opportunities Prices are in Canadian dollars and are subject to a 13% HST. A $99 processing charge will be assessed to all registrations not accompanied by credit card payment at the time of registration. MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC * CT residents or people employed in the state of CT must add 6% 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: Bank-HSBC Account # 002-385-007-001 SWIFT Code HKBCCATT Reference: Please include the name of the attendee(s) and the event number: 11165.005 Payment Policy: Payment is due in full at the time of registration and includes lunches and refreshment. Your registration will not be confirmed until payment is received and may be subject to cancellation. 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. ©2010 IQPC. All Rights Reserved. The format, design, content and arrangement of this brochure constitute a trademark of IQPC. Unauthorized reproduction will be actionable under the Lanham Act and common law principles. Register by Register by December 17, 2010 January 28, 2011 Standard Price Conference Only (save $1,000) (save $500) $999 $1,499 $1,999 Conference + 1 workshop (save $1,000) (save $500) $1,548 $2,048 $2,548 Conference + 2 workshops (save $1,100) (save $600) $1,997 $2,497 $3,097 Workshop(s) $549 each $549 each $549 each Industry Pricing Registration Information Venue: For accommodations information, please visit the event website at www.ColdChainPharm.com. Accommodations: 7Register by December 17th to Save up to $1,100! Register by Register by December 17, 2010 January 28, 2011 Standard Price Conference Only (save $1,000) (save $600) $2,599 $2,999 $3,599 Conference + 1 workshop (save $1,000) (save $600) $3,148 $3,548 $4,148 Conference + 2 workshops (save $1,100) (save $700) $3,597 $3,997 $4,697 Workshop(s) $549 each $549 each $549 each Other Pricing Government agencies, Pharmacies and Hospitals are eligible for a 50% discount off standard Industry pricing Industry pricing is eligible for manufacturers of finished bio-pharmaceutical products, IMPs, drug components or medical devices.
  • 8. 11165.005 International Quality & Productivity Center 535 5th Avenue, 8th Floor New York, NY 10017YES! Please register me for: See page 7 for pricing details ❑ Main Conference Only REGISTRATION CARD 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__________________________________________________________________ ❑ Please keep me informed via email about this and other related events. ❑ Check enclosed for $_________ (Payable to IQPC) ❑ Charge my __AmEx __Visa __Mastercard __Discover Card #__________________________________Exp. Date___/___ CVM code ______ Details for making payment via EFT or wire transfer can be found on preceding page. ❑ I cannot attend, but please keep me informed of all future events. 5 EASY WAYS TO REGISTER: 3 2 1 4 5 Web: www.ColdChainPharm.com/Quality Call: 1-800-882-8684 Email: info@iqpc.com Fax: 1-646-378-6025 Mail: IQPC 535 5th Avenue, 8th Floor, New York, NY 10017 ❑ Workshop(s) ❑ A ❑ B ❑ C ❑ D ❑ E CC Presents the CC February 22 - 24, 2011 Westin Prince Hotel, Toronto, Ontario, Canada Sponsored By: