Conference Day Two: Thursday, February 25, 2010

8:00 Registration And Coffee

8:30 Welcome Address And Chairperson’s Opening Remarks

Rafik H. Bishara
PhD, Technical Advisor, Chair, Pharmaceutical Cold Chain Interest Group (PCCIG)
Parenteral Drug Association (PDA) Transportation and Logistics

8:45 Comparing Cost And Packaging Strategies For Air And Ground Shipping For Your Cold Chain

  • Knowing the storage characteristics of the product and the most appropriate temperature regime
  • Determining the appropriate temperature by small-scale storage trials
  • When transporting by air, there is very little availability of even limited temperature control
  • Addressing packaging-related issues with freight transfers from air to ground
  • Validating packaging requirements with shipment size, risk mitigation and cost comparisons

Eric Malouin
Ing, Distribution and Operations Supervisor
Abbott Canada

9:30 Panel Discussion: Complying With IATA Chapter 17 Revised Regulations And Biopharma Requirements For Temperature Sensitive Products

  • Quality Management Systems requirements (including exception management)
  • Understanding processes and responsibilities of the shipper, forwarder, ground handlers/transportation service provider, consignee, and air carrier processes and responsibilities
  • Storage and warehousing requirements (including temperature mapping)
  • Introduction of new Time & Temperature sensitive handling label usage requirements

Kevin O’Donnell
Director & Chief Technical Advisor, Tegrant Corp., ThermoSafe Brands & Chair
IATA Time & Temperature Task Force

Ameet Sareen
Manager, Cargo Products
Air Canada Cargo

Representative
Kuehne + Nagel Ltd.

10:15 Morning Networking Break

11:00 Implementing Measurable And Repeatable Cold Chain Logistics Processes Using A Core Team Approach

  • Reviewing how a disciplined process proactively measures provider performance, and through change, creates confidence in desired outcomes.
  • Defining the post-shipment analysis process: Shipping Summary Report and Transport Evaluation
  • Working with a Core Team approach to establish Transport Evaluation Criteria
  • Putting our process to the test: Measuring provider performance - What can we do with the data?
  • Leveraging this information with providers to identify, change, strengthen or eliminate the weak link
  • Using continuous improvement to create a sustainable process

Jim Bacon
Senior Director, Global Demand Planning & Customer Operations
Talecris Biotherapeutics, Inc.

11:45 New Monitoring Technologies To Meet Temperature Challenges During Warehousing And Transportation

In this presentation, we explore the latest available monitoring solutions for a safe and efficient supply chain, and to ensure the implementation of the right technologies.

  • Presenting the cold chain compliance and management principles, particularly in terms of monitoring and tracking
  • Presenting the various monitoring solutions and their technical capacities and features that can apply onto temperature control of drug products during storage and transportation
  • Presenting cold chain monitoring solutions and their implantation in typical stakeholders of the Canadian supply chain (e.g. wholesalers/distributors, pharmacies, etc)

Jean Bédard
Chief Executive Officer
Alternatives Technologie Pharma

12:30 Networking Luncheon

1:30 Setting Up An Effective Recycle And Reuse Program For Your Cold Chain

  • Working with environmentally-conscious partners to develop recycling programs on an ad-hoc basis without increasing spending
  • Encouraging pharmaceutical manufacturers and temperature sensitive distributers to return all formats of digital and analog time/temperature data recorders for proper recycling
  • Encouraging participation at receiving locations, by providing display posters to those requesting them
  • Introducing a “Green Solutions” Recycling Program to promote the return of all time/temperature data collection instruments for recycling

Speaker to be confirmed

2:15 Panel Discussion: Understanding And Implementing Green Cold Chain Recyclable Packaging Practices And Initiatives

  • Addressing the need to create sustainable products that protect temperature sensitive goods
  • Maximizing the use of renewable or recycled source materials
  • Displaying a drug manufacturer’s perspective: How safe, efficient, cost effective and green are the solutions on the market?
  • Discussing lean initiatives, internal recycling programs, energy conservation, reusable solutions, and recyclable products
  • Identifying green packaging solutions for a variety of cold chain shipment sizes and irregular goods
  • Matching the right shipment to the right recyclable

Moderator:
Maurice Barakat
President & CEO
TCP Reliable

Panelists:

Gloria Markiewicz
Associate Director, Supply Chain
Novo Nordisk Canada Inc
Carolyn Williamson
PhD, Validation Scientist
Bristol Myers Squibb

Steven Skallerud
Vice President, Sales & Marketing
Entropy Solutions Inc.

3:00 Afternoon Networking Break

3:30 Challenging The Cold Chain With Distribution To Rural And Remote Locations

  • Confronting distribution challenges for vaccines transported to rural and remote locations
  • Obtaining operational efficiency with the use of monitoring systems to track shipments
  • Harmonizing guidance for storage and transport of temperature-sensitive pharmaceutical products
  • Consolidate regulations and guidance on the storage and transport of temperature-sensitive pharmaceutical products from a wide range of international sources into a single, relatively short document
  • Developing an international guide to good practice in this field, whilst accepting that local legislation and regulations will continue as precedence
  • Leveraging end-user participation through training and communication

Umit Kartoglu
MD, PhD, Scientist
World Health Organization (WHO)

4:15 Panel Discussion: Addressing Canadian Regulatory Frameworks From Manufacturer-To-Pharmacy

Ensuring end-to-end temperature and product stability throughout the entire cold chain requires collaborative relationships, compliance at every stage, and responsibility to adhere to regulatory guidelines from the manufacturer to the pharmacy recipient. This regulatory panel will address country-specific standards and provide case studies to inform regulatory best practices and ultimately strengthen compliance of cold chain distribution throughout Canada.

Moderator:
Allan Reynolds
Vice President, Industry and Member Relations
Canadian Association for Pharmacy Distribution Management (CAPDM)

Panelists:

Sarah Skuce
Compliance Specialist
Health Canada
Claude Jolicoeur
Director, Regulatory Affaires, Corporate GMP Officer
McKesson Canada
John Collins
M.Sc, Director, Quality Assurance
Novartis Pharmaceuticals Canada Inc

5:00 Best Practices for Effectively Managing Your Cold Chain on a Limited Budget

  • Understanding Cold Chain best practices for ship multiple product sizes efficiently
  • Discussing effective strategies and methods for simplifying the process without threatening QA
  • Cutting costs on the consumerables and effective waste elimination
  • Understand if you are saving or making money in the long run
Hashim Ayyaril
Manager, Product Logistics, Ortho Clinical Diagnostics
Johnson & Johnson
John Collins
M.Sc, Director, Quality Assurance
Novartis Pharmaceuticals Canada Inc

Dana Dallas
Cold Chain and Vaccine Program Manager, Department of Defense
Defense Supply Center Philadelphia

5:45 Chairperson’s Closing Remarks And Close Of Conference

 
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