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Audio conference highlights

Global transport of temperature-sensitive investigational drugs and clinical materials presents a tremendous challenge for pharmaceutical and biotech companies. There are many factors to consider in order to ensure that product integrity remains intact. Successful delivery of investigational drugs from origin to patient is becoming more complicated, especially with increased scrutiny placed on in-transit temperature control and monitoring. As cold chain shipment excursions face increased scrutiny from regulators around the world, it is more important than ever to get it right the first time.

In this audio conference, the speakers review the areas that need to be considered by the clinical development community in order to maximize the performance of their cold chain R&D investments.

This audio conference covers:

• Strategic logistical planning, including regulatory issues, documentation and transportation partner responsibilities
• Packaging options in order to maintain product integrity
• How to avoid temperature excursions
• Chain of custody and how it impacts the successful delivery of cold chain materials

About the speakers:

Anthony Leone is the International Customer Service Manager for World Courier, a company that specializes in the international transportation of clinical supplies and diagnostic materials, supported by a global network of over 140 offices. He oversees several departments involved in the exports of time- and temperature-sensitive shipments globally. In the 12 years that Anthony has worked with the company, he has developed expertise in the areas of implementation of client-specific and operational SOP’s, import/export and regulatory issues, and packaging options -- all in support of customers shipping clinical supplies and/or diagnostic materials.

Les Sparrow has been with World Courier for 18 years, and is currently the Quality Assurance and Technical Support Manager. Les leads a team that interfaces with every intra-company department, monitoring all cold chain related activity. It is his responsibility to ensure that the company meets or exceeds client expectations by using optimum logistical planning and the most current tools to maintain temperature integrity. This group creates and modifies SOPs that secure this goal.

Who should attend?

• Clinical Supply Chain Management
• Global Logistics Management
• Clinical Services Managers/Directors/VPs
• Clinical Project Managers
• Managers of Clinical Supplies
• Clinical Operations Management

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.