Pre-Conference Specialist Discussion Forums: Tuesday, 27th January, 2009

Please click on the links below to learn more:

• A: Understnding International Dangerous Goods Regulations for Hazardous and Biological Material
• B: Considerations for Transporting Temperature Sensitive Pharmaceuticals
• C: How to hold your Cool Chain Partners to High Quality Operational Standards: The Cool Chain Quality Indiator (CCQI)
• D: Builing Strong Post-Qualification Operational Partnerships to Support Global Cold Chain Supply: Taking Technology From the Lab to Global Supply Operations
• E: Implmenting Innovative Shipping Solutions Supporting the Global Distribution of Clinical Supplies
• F: Evaluating Reusable and Recyclable Packaging or your Cold Chain Logistics

8.30 - 11.30 A: Understanding International Dangerous Goods Regulations for Hazardous and Biological Material

What you will learn:

• Dangerous Goods regulatory overview and legal implications
• Identification and classification of substances as dangerous goods
• Package specification and UN Testing
• Labeling, marking and documentation
• Operator, state and country variations

How you will benefit:

• Compliant packaging and packaging instructions
• Pharmaceutical shipments
• Clinical trial shipments
• Temperature controlled shipments
• Choosing a risk profile for your biological material shipping
• Comparing import / export challenges and instances and workable solutions to overcome them

Your discussion leaders:

OR

08.30 - 11.30 B: Considerations for Transporting Temperature Sensitive Pharmaceuticals

What you will learn:

• Documentation audit trail
• Effective procedures to address transport risk issues
• Expectations for real time monitoring
• Effective contingency planning

How you will benefit:

• Gain an appreciation for common errors in truck qualification approaches
• Improve your ability to effectively partner with your carrier to maximize the quality, consistency, and economy of your shipping lane

Your discussion leaders:

11.45 - 14.45 C: How to hold your Cool Chain Partners to High Quality Operational Standards: The Cool Chain Quality Indicator (CCQI)

What you will learn:

• Breaking down the cool chain into its links; The Management system; The Master tables; The Benchmarks; The Certification
• Relating the CCQI to specific pharmaceutical industry needs
• Special cool chain requirements in case of pharmaceuticals
• Active temperature control
• Passive temperature control
• GMP / evaluation requirements
• Documentation

How you will benefit:

• How does the CCQI standard cover the special requirements of the pharma industry?
• Is there a need to develop further master tables for the pharma industry?
• Comparing quality standards in different modes of transport – Sea vs. Rail vs. Air vs. Ground

Your discussion leader:

Wilhelm Loskot
Head of Department, Shipping and Logistics
Germanischer Lloyd Certification GmbH

OR

11.45 – 14.45 D: Building Strong Post-Qualification Operational Partnerships to Support Global Cold Chain Supply: Taking Technology From the Lab to Global Supply Operations

What you will learn:

• This workshop will explore how you can implement:
• Inter-company relationship building
• Stock control solutions
• Cross-border supply vs. local supply
• Supporting sustainable networks

How you will benefit:

To ensure successful transition from lab to supply operations, attend this workshop to:

• See examples of existing best supply practices
• Discuss examples of how to eliminate product failures caused by not considering the logistical and supply issues of parts that may require pre conditioning
• Understand how far you can take the aspects of solution supply to further strengthen your cold chain

Your discussion leader:

Nicki Jackson
Operations Manager
Cool Logistics

15.00 - 18.00 E: Implementing Innovative Shipping Solutions Supporting the Global Distribution of Clinical Supplies

Why you will learn:

With the rise in the global distribution of clinical trials, accompanied by the rising complexity of protocols and the handling requirements associated with biologics and specialty drugs, the need for proactive planning with your supply chain is more critical than ever before. This workshop will cover the following areas:

• Designing pre-qualified systems for clinical trials
• Ensuring quality re-qualification and validation
• Integrating the supply chain: The role of data
• Predicting the future: A look at ongoing development

How you will benefit:

This workshop will explore pragmatic issues.

• How much data should be shared with partners?
• How to monitor through data: Excursions and successes
• What is the answer for cold chain packaging for international IMPs? How can we balance cost without overengineering
• Understanding how to comply with guidance on ordering, shipping, and returning clinical supplies.

Your discussion leader:

Rognvald Lamb
EMEA Logistics Manager
Fisher Clinical Services

OR

15.00 - 18.00 F: Evaluating Reusable and Recyclable Packaging for your Cold Chain Logistics

What you will learn:

• Regulations on cold chain and reusable packaging
• Minimising number of shipment is one way to reduce cost and improve environmental consequences
• Understanding perceived cost issues
• Estimating the initial investment vs. long term value gains

How you will benefit:

• Select the right thermo packaging for the job
• How to integrate in your logistic management the unlife packaging concept: One way or/and Reused?
• Utilise unlife packaging to balance costs, security and environmental impact of your cold chain operations

Your discussion leader:

Gilles Labranque
Chairman & Managing Director
Sofrigam