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Evolving sectors gain attention at global forum

Medical devices and diagnostics, generics, APIs, and biologics are on the agenda at the 9th Annual Cold Chain & Temperature Management Global Forum Sept. 26-30.
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The 2°- to 8°C temperature range is a common “cold chain” discussion area, but temperature control in ambient and other ranges, as well as regulatory matters and evolving sectors are gaining importance in the life cycle of temperature-controlled healthcare-related products.

These issues, along with “cost pressures, a focus on core competencies, and virtual company models are driving an increase in outsourcing and the need for robust and transparent partnerships,” said Courtney Becker-James, event director, IQPC, in announcing the Sept. 26 – 30 Cold Chain & Temperature Management Global Forum at the Pennsylvania Convention Center.

She said, “The biopharmaceutical market, worldwide, is set for high growth. This growth of novel biological therapies, including monoclonal antibodies, cell therapies, cytokines, and new vaccines, is setting the scene for tomorrow’s cold chain, demanding an increase in specialty packaging, handling, and distribution as a result of vibration sensitivities at certain frequencies and the affects of relative humidity.

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“The 2011 Global Forum will reflect these changes in the market and bring hard-hitting new information, peer-to-peer experiences on overcoming the most pressing issues facing temperature-control logistics and QA professional,” says Becker-James.

New topics for the 9th Annual Global Forum include the following:

• Ensure product quality from bulk design to distribution with focused tracks dedicated to product lifecycle, and case studies from Merck, the Biomedical Advanced Research and Development Authority, and the U.S. Dept. of Health & Human Services.

• Share best practices and learn how clinical supply stakeholders can work together to ensure no lost time, patient, or bio samples at the Bio Clinical & Lab Logistics Focus Day.

• Learn the importance of SOP’s and Quality Agreements, trends in distribution, and take part in practical demonstrations of packaging solutions and temperature monitoring at the Training Days on Good Transportation Practices for Air, Road and Ocean for Temperature-Sensitive Healthcare Products.

Speakers at the event will include Chris Anderson, director, quality and regulatory affairs, Cardinal Health; Alan J. Davis, supply chain temperature control leader, Johnson & Johnson, Jim Bacon, senior director, global demand planning & customer operations, Talecris Bioteherapeutics, Inc.; Marvin Dyke, general manager, Fisher Clinical Services, Dr. Mary Foster, chair, packaging and storage expert committee, U.S. Pharmacopeaia, Geoffrey Glauser, Biomedical Advanced Research and Development Authority, U.S. Dept. of Health & Human Services (he will chair a “Cold Chain Packaging” track on Sept. 28); Dan Gourley, logistics director, clinical supply services, Catalent Pharma Solutions, Chris Fore, compliance manager, Envirotainer; Gary Hutchinson, director of corporate transportation, Amgen; Dawn Kreuz, senior stability coordinator, Merck; Sal Mann, manager, package engineering, Allergan; Kevin J. McPehrson, global marketing director, product management & CRM, UPS Healthcare Logistics; Arminda Montero, global distribution QA program manager, global pharmaceutical operations, Abbott; Sarah Skuce, compliance specialist, Health Canada; Anthony Alleva, technical services manager, Cryopak, a TCP Reliable Co.

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