Risk Management - global temperature surveillance best practice for clinical trial supply
Ever tightening regulatory demands, the geographical complexity of supply chains and the continued growth of biological investigational products 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 issue. 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 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/eliminate excursions, improve supply to patients and provide a better global supply chain for the benefits of all.
If you are involved in global clinical trials that require cold chain distribution of investigational products, this is a must attend webinar to help you comply with regulations, minimize temperature excursions and manage risk for global clinical supply while saving both time and money.
Presented by
Sharon Courtney,
Logistics Service Manager
Sharon is an International Logistics Specialist having worked for 18 years in Clinical Supply Chain. She has expert knowledge in a number of key areas within the end to end supply chain process including management and control of temperature sensitive shipments; risk mitigation (identifying and managing risk); developing and managing robust relationships with transport partners; chain of custody responsibilities; active and passive shipping solutions and import/export country knowledge.
Sharon has consistently delivered reliable and validated logistics solutions for customers based on her experience of establishing numerous international logistics models over the years. Sharon is passionate about providing excellent customer service in the area of logistics and this is demonstrated in her understanding of every role within the end to end supply chain process.
She has first-hand knowledge of working with customers, external organisations and the appropriate departments within Almac to deliver well established logistics solutions in the Pharma industry. Sharon has travelled widely with her work and has been instrumental in the development of the logistics service provided by Almac.
Heather Bogle,
Supply Chain Solutions Manager
Heather Bogle graduated from Queens University Belfast with a BSc in Chemistry. She joined Almac in 2001 and has worked with a wide range of Pharma and Biotech companies, from small specialist providers to multinationals, to manage supply chains across the full range of sponsors and trial designs.
Heather has first-hand experience in managing the supply chain for studies across the globe with temperature sensitive products. She has expert knowledge on the challenges with temperature surveillance throughout the supply chain and extensive experience developing creative, efficient and robust solutions.
