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Cool and Controlled – How EU Guidelines Impact Shipments


By: Alex Guillen February 22 2017

Tags: Cold Chain, Logistics for Clinical Trials, Clinical Supply Optimization

EU Guidelines Impact Shipments

A patient’s well-being ultimately overrides any concerns about cost-efficiency across the clinical supply chain. But as EU guidelines become increasingly demanding in terms of protection of IMP and liability, biotech and pharmaceutical companies are discussing whether to invest in controlling or monitoring their shipments. The revised regulations have made this question more pertinent, as they apply to all shipments including ambient shipments. A company’s decision on how to optimize their supply chain depends on three factors: risk assessment; historical data on product stability; and cost. In addition they need to consider compliance to regulations in their process and that their actions are traceable.

I am often asked about my thoughts on the current debate surrounding supply chain optimization. I am pleased to share these thoughts with you via a recent interview with Clinical Trials Insight and the World Pharma organization. Our discussion includes answers to the following questions and gives some top tips for end-to-end supply chain management:

• What is the biggest issue facing supply chain management for clinical trials?
• What’s your opinion on the revised EU GDP guidelines?
• Do they ensure product integrity up to the last mile?
• How can we help investigator sites maintain product integrity?
• How can sponsors make informed decisions on whether to monitor or control shipments?
• How will technological advances affect the supply chain management in the coming years?