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Global Temperature Surveillance and Best Practice For Clinical Trial Supply
Ever tightening regulatory demands, the geographical complexity of clinical supply chains, and the continued growth of biological Investigational Medicinal Products (IMPs), have increased the importance of having a robust system for monitoring the temperature of these products. Sponsor companies are rightly insisting that the integrity of their products is maintained throughout the product lifecycle from manufacture to patient administration. The focus is not just on the cold chain; temperature surveillance of ambient products is rising. Controlling costs by minimizing waste of medication and efficiently removing out of spec product must be key considerations when developing a temperature management plan. The plan must also be robust enough to withstand regulatory scrutiny.
In this webinar we will examine the current Good Distribution Practice (GDP) (USP and MHRA) requirements for temperature management and the impact these regulations have on clinical supplies. We will also provide an overview of the key factors involved from a risk management perspective based on a detailed stakeholder analysis including logistical challenges (couriers, destination airports, shipping lanes) and applicable technologies.
Ultimately, we will provide an overview on how you can develop best practice and implement temperature management processes that will drive down and eliminate excursions, improve supply to patients and provide a better global supply chain for the benefits of all.
Key Learning Objectives:
- Understand the impact of GDP regulations on global clinical supply
- How to develop a risk management strategy
- Understand how to manage temperature excursions across the complete Investigational Medicinal Product (IMP) lifecycle
- How in country expertise can drive decision making
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