Pre-Conference Workshops & Specialist Discussions: Tuesday, September 27, 2011

CHOOSE WORKSHOP A OR B

8.30 - 11.30 Workshop A: Implementing a Pre-Qualified Packaging System into an International Cold Chain

Increasing regulatory requirements coupled with shortened time to market and limited resources for life science companies has led to an increase in the use of "pre-qualified" passive shipping solutions. Evaluating and implementing these solutions across international as well as domestic shipping lanes can bring as many questions as answers. This workshop is designed to help you identify and provide answers to those questions.

What you will learn:

• Considerations and trade-offs used when designing a pre-qualified system
• What standards exist for international shipments
• Be able to evaluate a pre-qualified system for your specific needs

How you will benefit:

• Identify what risks could be associated with these systems.
• How they can be used in the development of future alternatives
• How they can fit into your current short term and long term requirements

Your Workshop Leader:

Anthony Alleva
Technical Services Manager, Cryopak
a TCP Reliable Company

8.30 - 11.30 Workshop B: Variable Assumed Risk - Ambient Thermal Profile (ATP)

Qualification of packaging begins with the development of an Ambient Thermal Profile that is typical of the conditions a package is expected to encounter during shipment. The profile should be based on a sound rational and should take into consideration temperature conditions at origin, destination, and throughout the complete route, seasonal variations, transport routes and modes, total duration of transit, duration, temperature and location of various handling and stopover points, and product handling, among other variables.

While environmental profiles should be based on realistic expectations, weighing the tradeoffs and associated costs (packaging, distribution, etc…) relative to the robustness of the profile has heretofore been cumbersome at best. This new Variable Assumed Risk methodology enables the user to modify an ambient profile based on various risk components – therefore enabling the optimization of packaging and logistics costs based on a sound rational supported by science.

The workshop will focus on two objectives:

• Outlining the benefits of this new methodology, and
• Comparing and contrasting this new methodology against commonly accepted methodologies for profile development

Workshop Leaders:

CHOOSE WORKSHOP C OR D

11.45 - 2.45 Workshop C: 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. Take part in these discussion to understand:

• Drivers for leasing programs: Quality, cost, sustainability and CO2 footprint
• Examples of company supply chains, gaps and what's driving their supply chain integrity (customers, senior management, private investment firm?)
• Shipper's strategy to single source or outsource and impact to decisions on leasing program viability for their supply chain
• The leasing network: Service level agreements, subcontracting and partners

Key Perspectives:

11.45 - 2.45 Workshop D: Real Solutions to Current Challenges in Cold Chain Distribution

Actual case studies detail successful approaches and effective solutions to the latest issues in temperature-controlled distribution. Participants will gain insight on how other industry players are addressing these issues.

• Ambient product protection
• Developing effective bulk shipment platforms
• Utilizing advanced materials in passive shipper designs
• Solutions for emerging markets
• Meeting aggressive launch targets: Practical application of analytical modeling

Your Workshop Leaders:

Registrants will be Qualified to be End-User Participants Only

3:00 – 6:00 Workshop E: Training Course for Cold Chain Suppliers

“General logistics firms see pharmaceuticals as an attractive market with potentially higher margins,” ... (despite) growing interest in providing cold chain services for the life sciences market, not all 3PLs are interchangeable. Life Science Leader, April 2011 article "Partnerships in Cold Chain Delivery"

Whether you're new to cold chain or have been developing your bio pharma cold chain product or service for years, understanding how to work within the bio pharma industry is critical to winning the business and maintaining a high-quality, regulatory compliant service or product.

Session I: Introduction to Working with Temperature Control Market and Executive Market Overview

This introductory session will be for the senior level executive at a supplier company, as well as the new customer-facing sales rep or account manager who need to be knowledgeable on:

• Basic components of cold chain & Cold Chain Terminology Dictionary
• Operating in a heavily regulated industry: GDP, GMP, GCP
• Market forecast for cold chain suppliers

Session II: How to be a Compliant Packaging Provider

This session will be tailored to packaging providers to dig deeper into the critical issues and key decision-making topics for their customers, including discussion on:

• Sub-markets requiring temperature assurance
• Standards to follow to be competitive:
  • i.e IQ, OQ, PQ and CQ
  • i.e Regulatory – mapped and defined
  • i.e USP <1079>, PCCIG TR 39, HC 0069, IATA (PCR)
  • i.e. Non-regulatory - GMP, GDP, GCP
  • i.e. ISTA 5B, 7E, Standard 20
  • i.e. ASTM

Session III: Service Providers: Warehousing, Logistics, Redundancy, Audits, QA

This session will be geared to warehousing and logistics personnel working directly with the market including discussion on:

• Trends and expectations of each market for its service suppliers
• Expectations in auditing, quality assurance and redundancy of your solution
• What requirements must we follow to be competitive: i.e Regulatory and non-regulatory guidance– USP <1079>, PCCIG TR 39, HC 0069, IATA (PCR) & GMP, GDP, GCP

Workshop Leader:

Richard C. Ellinger
Principal
Temperature Assurance Group