Case Study: Insights and Considerations for the Globe-trotting Cold Chain Supplier of Investigational Medicinal Material” at the 9th Annual Cold Chain & Temperature Management Global Forum at 12:30 pm on Friday, September 30 in Philadelphia, PA.
The proliferation of multinational clinical trials for medicinal products has spurred rising demand for global cold chain supply services. This cold chain supply management case study of a Phase III medicinal product will outline some of the unique challenges in maintaining cold chain continuity to study sites in emerging markets across the globe. This case study will use examples from the Phase III trial to address:
Security: Protecting against damage, loss, or theft while en route or upon arrival
Maintenance of cold chain conditions in air and on the ground
Planning, adaptability and contingency plans to ensure supply continuity
Required documentation and deciding on the stated value of the material - a complex business decision that carries a certain level of risk
Regulatory compliance: Ensuring correct valuation of material to decrease any risk of potential delays with many country's regulatory authority agencies
Improvements in kit design: Smaller, lighter, cost-effective packaging
Technology enabling tracking of temperature and location: Real assurance
Dan Gourley, Director of Logistics at Catalent Pharma Solutions, is responsible for global distribution, returns and warehousing of clinical supplies for Catalent's Philadelphia clinical site. He has previously worked as the Controller and Director of Finance, handling global financial business for Catalent's Clinical Supply Services. Prior to Catalent, Mr. Gourley held management roles in the finance arena having a direct influence on day-to-day operations. Mr. Gourley has a Bachelor's of Science degree in Business Administration/Accounting from the University of Slippery Rock.
The proliferation of multinational clinical trials for medicinal products has spurred rising demand for global cold chain supply services. This cold chain supply management case study of a Phase III medicinal product will outline some of the unique challenges in maintaining cold chain continuity to study sites in emerging markets across the globe. This case study will use examples from the Phase III trial to address:
Security: Protecting against damage, loss, or theft while en route or upon arrival
Maintenance of cold chain conditions in air and on the ground
Planning, adaptability and contingency plans to ensure supply continuity
Required documentation and deciding on the stated value of the material - a complex business decision that carries a certain level of risk
Regulatory compliance: Ensuring correct valuation of material to decrease any risk of potential delays with many country's regulatory authority agencies
Improvements in kit design: Smaller, lighter, cost-effective packaging
Technology enabling tracking of temperature and location: Real assurance
Dan Gourley, Director of Logistics at Catalent Pharma Solutions, is responsible for global distribution, returns and warehousing of clinical supplies for Catalent's Philadelphia clinical site. He has previously worked as the Controller and Director of Finance, handling global financial business for Catalent's Clinical Supply Services. Prior to Catalent, Mr. Gourley held management roles in the finance arena having a direct influence on day-to-day operations. Mr. Gourley has a Bachelor's of Science degree in Business Administration/Accounting from the University of Slippery Rock.
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