Oral drug delivery technologies form an important part of the pharmaceutical industry, and represent the largest share of the overall market.
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.
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.
Vickie Johnson,
Project Group Manager
Vickie graduated from West Virginia University with a BS in Pharmacy. She received her Masters of Heath Care Administration from the University of North Carolina, Chapel Hill. Before joining Almac, Vickie began her career as a retail pharmacist; she subsequently moved to a staff pharmacist position at UNC Hospitals where she was named supervisor of the Investigational Drug Services.
During this time she was instrumental in establishing an investigation pharmacy for HIV research in Malawi, Africa. Since joining Almac in 2005, Vickie has worked with Pharma and Biotech companies to manage supply chains across the full range of sponsors and trial designs and has been a key figure in establishing Almac's Lifecycle Temperature Monitoring service offering.
- Understand the impact of GDP regulations on clinical supply
- How to develop a risk management strategy
- Understand how to manage temperature excursions across the complete investigational product lifecycle
- How in country expertise can drive decision making
- Clinical Trial Supply Manager
- Clinical Supplies
- Head Clinical Supply
- Clinical Trial Director
- Quality Compliance
- Regulatory Affairs
- Global Product Development
