Day One Conference: 25th January 2011

08.00 Registration And Coffee

09.00 Welcome Remarks Pharma IQ

09.05 Opening Remarks Chairperson

Maintaining Critical Temperatures during International Transportation

09.10 Exploring Opportunities For Consolidation Of Shipments To Improve Asset Utilisation And Decrease Transportation Cost

  • Balancing cost with quality: Quality as a determining factor for deciding which transportation mode, lane and partner to use
  • Assessing LTL and LCL opportunities
  • Results of an FMEA analysis on LCL
  • Use of combi-trucks (2-8C + 15-25C)
  • Understanding the effect of loading CRT products in cool trucks

David A Ulrich
QA Director - Distribution, Global Pharmaceutical Operations, Strategic Quality Initiative, Distribution QA
Abbott Laboratories

09.45 Air Cargo Capacity: The Future Of Transporting Vaccines To Developing Countries

This presentation will give an evaluation of the airline industry’s ability and challenges in meeting the future transport demands of the World Health Organisation (WHO), including:

  • Key drivers for increased cubic volume of vaccines, pharmaceutical and biologics
  • An overview of the state of the airline / air cargo industry
  • Current and future survival scenarios
  • Understanding fleet, routes and consolidation factors
  • Analysing the regions/airports that are of most concern
  • The domino effect
  • Effective approaches to overcoming the challenges

Umit Kartoglu
Technical Officer and Scientist
World Health Organisation

10.20 Ensuring That Airport Facilities And Infrastructure Maintain Required Temperatures

  • The airport authority’s role in ensuring product quality, working with airlines and having an influence on the cold chain process
  • Examining the infrastructure challenges at some large international airports
  • Quality measures and accountable action plans that airlines have in place with airports to ensure temperature control
  • Establishing a collaborative approach between the shipper, freight forwarder, airline and airport authority

Bart Pouwels
Director Business Development
Amsterdam Airport Schiphol

10.50 Morning Networking Break In Exhibition Arena

Join your peers to browse the 2011 Solution Hall. Open across the 2 days this is where you’ll be able to find all the latest packaging/container, transportation, logistics, temperature monitoring and data management solutions. The ideal place to meet existing and new partners!

11.20 Air Freight Options For 15-25C Requirements

In the Pharmaceutical Industry a growing demand for a 15-25C product can be notified. Airlines are preparing themselves to see how to meet this demand although different directions for solutions exist.

Topics to be addressed during the panel discussion are:

  • Current solutions: What are they and what are critical points?
  • When to move from an open to a closed solution and vice versa?
  • Future developments: Which direction to follow?

Martin Blok
Director Pharma
Air France – KLM Cargo

11.55 Thermal Blanket Technology For CRT (Controlled Ambient) Shipments

  • The science of thermal protection
  • Assessing blanket thermal performance for CRT cargo
  • Measuring return on investment
  • Case study using thermal blankets protecting CRT cargo

Peter Lockett
Global Thermal Product Manager
AmSafe

12.25 Novel Technologies Shaping The Future Of Vaccine Transport, Storage And Logistics

Project Optimize, a collaboration of WHO and PATH, has been given a unique mandate to identify, develop and test solutions to help supply chains keep up with rapidly advancing vaccine and delivery device technologies needed to safely and effectively deliver needed vaccines to middle and low income countries. This presentation will examine in-progress collaborative demonstration projects to assess the impact of technology innovations on the efficiency and sustainability of supply chain and logistics systems and the availability and quality of products that move through the system. Points include:

  • Thermos table vaccines stored out of the traditional cold chain yet in a “controlled temperature chain”
  • Longer term passive storage containers
  • Solar “battery free” vaccine refrigerators
  • “Zero energy” cold chain including electric vehicles
  • Further examples from demonstration projects in Albania, Guatemala, Senegal, South Africa, Tunisia and Vietnam

Steve McCarney
Cold Chain Technologies Specialist - Project Optimize
PATH

13.00 Discussing The Need For 24/7 Cold Chain Monitoring To Ensure Patient Safety

Due the presence of multiple uncontrolled variables in the distribution process, developing an appropriate temperature program is essential to protect is essential to protect the quality of environmentally sensitive pharmaceuticals and to protect patient safety.

This discussion covers:

  • The need for cold chain monitoring to ensure patient safety today
  • Assessing the advantages of 24/7, live Cold Chain information
  • Looking to the near future: Discussing the possibilities to improve efficiency, sustainability and safety by live data.

Mark Roemers
CEO
Dyzle | The Live Company

13.15 Panel Discussion: Temperature Monitoring Methodologies For Different Stages Of The Drug Supply Chain

This panel will review the risk-based decision process and criteria that led to different monitoring methodologies employed for different stages of the drug supply chain – while ensuring the goal of product quality and patient safety. An explanation of when full time/temperature data loggers are used, as well as, when temperature indicators are employed for later stage (direct-to-site) shipments will be given. Points for discussion include:

  • Regulatory pressures and requirements to monitor to the patient
  • The impact of mail order and home delivery care distribution methods
  • Temperature monitoring and deviation training methods
  • Product release/quarantine processes
  • Reduction in excursion trends
  • Workload and QA staffing required
  • Utilisation of stability data

Moderator:

Henry Ames
Director, Strategic Marketing
Sensitech

13.50 Networking Lunch

Discuss the morning’s presentations and current concerns with like-minded colleagues by joining the networking lunch with peers in QA, logistics, technology development or packaging.

Track A: Improving the Performance of your Cool Chain Packaging

Track B: Understand Industry Approaches to CRT and Ambient Temperature Strategies

14.45 Assessing Cost-Effective “Last Mile” Packaging Solutions That Ensure Patient Safety And Product Efficacy

  • Identifying the needs of the product and the needs of the patient
  • Defining a solution: Finding a portable, small, 2-8C ‘user-friendly’ packaging solution
  • A global solution that may easily be implemented by affiliates and their pharmacy partners
  • Understanding the qualification process
  • Completing the cold chain process by ensuring temperature control in the very last mile - from pharmacy to patient

Lisa Mazzoni
Project Lead, Temperature Controlled Supply Chain
F. Hoffmann-La Roche

14.45 Controlled Room Temperature (CRT) Case Study: Temperature Studies And Quality Issues

  • Overview on current and future logistic operators roles and responsibilities
  • Working with stakeholders to implement quality processes
  • Thermal blankets validation
  • Temperature monitoring: Friend or foe?
  • Thermal mapping transport routes
  • Improving air transport processes for CRT products

Zvonimir Majic
Manager Distribution, Croatia Operations, Supply Chain
PLIVA

15.20 How To Implement Cost-Containment And ‘Green’ Improvements In Your Cold Chain Logistics

After several years of testing, Sofrigram has worked with pharmaceutical clients to develop a solid understanding and capabilities for a successful and cost-effective implementation of ‘green’ logistics. This presentation will be based on practical case study results and discuss:

  • What does “green” mean in a logistics strategy?
  • When, where and how you have to act
  • How to evaluate results and benefits

Gilles Labranque
Managing Director
Sofrigram

15.20 Cost-Effective Shipment And Supply Of Medical Devices World-Wide

  • The temperature control distribution challenges of a small, global medical device company
  • Overcoming limited economical and personal resources
  • Assessment and implementation of cost-effective packaging
  • Working closely with freight forwarders to ensure cost-effective distribution
  • Distribution challenges due to the ‘Ash Cloud 2010’

Anna Hallgren
Senior Logistics Specialist
Vitrolife Sweden AB

15.55 Case Study: Designing A High Performance Cold Chain Shipping Systems

  • Utilising both vacuum panel insulation and custom phase change materials
  • Assessing materials cost vs. reusability benefits
  • Integrating new packaging systems into day to day operations

Fabian Eschenbach
Manager
va-Q-tec AG

16.10 Afternoon Networking Break

15.55 Afternoon Networking Break

Track A: Improving the Performance of your Cool Chain Packaging

Track B: Integrating and Utilising Temperature, Stability and Supply Chain Data

16.40 Case Study: Cold Chain Shipping Validation Of A Complex Global Pharmaceutical

  • Seattle Genetic’s supply chain structure and challenges
  • Temperature requirements of complex antibody products
  • Assessing and selecting active and passive systems most suitable for the products
  • Setting validation design parameters and expectations
  • Sharing validation results

Jon E. Ross
Senior Manager, Supply Chain Operations
Seattle Genetics

16.40 Pfizer Operational View: Developing Best Practice Company Guidelines For Global Shipment Tracking And Release

  • Retrieval, storing, tracking of temperature sensitive data
  • Trending of temperature data for individual lanes
  • Excursion management

Saddam Huq
Cold Chain Technology Lead
Pfizer Pharmaceuticals

17.15 Meeting Future Challenges In Global Temperature Controlled Shipping

  • A case study of Pharmerging markets: Demonstrating effective operational procedures for shipping to new markets
  • Fit for purpose: Designing packaging solutions to meet specific criteria and certain temperature ranges
  • Total cost of ownership: Calculating the packaging cost per liter volume shipped
  • Assessing sustainability initiatives for today’s temperature control shipping of pharmaceuticals

Steve Healy
Sales and Marketing Manager
SCA Cool Logistics

17.15 Pfizer QA View: Temperature Excursion Management During Transport And Integrating Temperature Data

  • Definition of the product transportation temperature range vs. label claim
  • Evaluation of temperature excursions relative to the quality and compliance impact
  • Perspectives on the evaluation/ investigation of excursions including MKT and stability data

Ian King
Global Logistics Regional Leader, Europe, Middle East and Africa
Pfizer

17.50 Phase Change Materials (PCMs) Test Results: Assessing How Product Integrity Is Maintained Whilst Enhancing Performance, Increasing Operational Efficiency And Ensuring A Company’s Sustainability Profile

  • Maintaining product integrity at <-20, 2-8, 15-25C
  • Can materials be combined to increase stability / enhance a package’s performance?
  • Are reductions in size, weight and volume of packages achievable with PCMs?
  • Can the use of PCMs simplify your packing operations and increase efficiency in a high pressure warehouse environment?
  • Recycle, re-use or retain? Which fits your distribution / business model?

Prakash Mahesh
Vice President, Marketing and Business Development
ThermoSafe Brands

Ken Maltas
Vice President, Engineering
ThermoSafe Brands

17.50 PCCIG Panel Discussion: Stability Data Generation And Sharing Of That Data

  • Discussing the current gap in international guidance and developing a consensus for industry best practices
  • Collecting the appropriate stability data to support wider shipping ranges
  • The possibilities and risks of shipping outside label claim
  • Sharing data with customers and partners for licenses, quality agreements and stability testing
  • Flat data or mean kinetic temperatures?
  • Russia’s new requirement: The shipping condition has to be part of the case label and the shipping documents

Moderator:

Rafik H. Bishara
PhD, Technical Advisor and Chair PCCIG USA Branch
PDA

Panellists:

Ian King
Global Logistics Regional Leader, Middle East and Africa
Pfizer

David A. Ulrich
QA Director - Distribution, Global Pharmaceutical Operations, Strategic Quality Initiative, Distribution QA
Abbott Laboratories

18.25 Closing Remarks

18.30 Networking Drinks Reception

19.30 Cool Chain Europe Gala Dinner And Excellence Awards 2011

Join your industry colleagues onboard a luxury ship for an evening of drinks, food, networking and an educational tour of the Port of Rotterdam - the largest port in Europe. You will learn about the history, day to day commerce and operational infrastructure of the port. Plus - to top it all off - the Excellence Awards Ceremony will be another feature of the evening and winners will be announced for the 2011 Award Categories:

  • Best Temperature Control Logistics Project
  • Best Quality, Qualification or Risk Management Project

Nominate your colleague or partner on the Cool Chain Excellence Awards page

 

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Cool Chain Europe 2010 Draft Agenda

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2011 Sponsors & Exhibitors

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2012 Sponsors & Exhibitors

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2011 Media Partners

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Our Sister Event Clinical Trial Supply Europe 2011

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Not only will Cool Chain Europe provide a jam packed programme of new speakers and networking opportunities, it is also taking place directly before our brand new sister event: Clinical Trial Supply Europe. This is your opportunity to come as a team to the conference of your choice, enjoy a great learning and networking opportunity and save money through our group discount rates!