Navigating Breaks in the Supply Chain and Managing Import Requirements — Solutions to Challenges in Importing & Delivering Clinical Trial Supplies
ELPRO is once again collaborating with Biocom California to co-host a series of educational webinar sessions taking place this summer and early fall.
The webinar series is for all life science practitioners in Supply Chain, Logistics, Packaging Engineering, Cold Chain, Quality Control/Quality Assurance, Clinical Supply and Commercial Operations or Warehousing. The sessions will include case studies, strategies and tools to preserve the safety and efficacy of temperature-sensitive products in-transit and in-storage.
With the aviation industry hit greatest during the COVID-19 pandemic finding logistical solutions within Europe and beyond to maintain the clinical trial supply chain during this period required creativity and proactive thinking. With clinical trial supplies also provided as compassionate use to support the treatment of COVID patients, sometimes in countries where the original clinical trial had not been taking place, import requirements were often only identified at the time of distribution.
Flight cancellations, closed borders within the EU, and restrictions on peoples movements all formed part of the challenges in importing and delivering clinical trial supplies. Find out how these challenges were overcome and how the industry can be prepared should alterative supply chain routings be needed in the future.
Meet our Presenters:
Christine Wenner, Senior Clinical Supply Chain Manager, US Clinical Services, PCI Pharma Services. As a leader in global clinical supplies packaging, labeling and distribution, Christine is responsible for implementing systems and processes that set industry standards. She holds over twenty years of continuous advancement in global clinical supplies management and quality. Her specialties include blinded clinical packaging and labeling, distribution/ColdChain/IVRS, process mapping, change management, quality systems, and label design and randomization generation.
Gavin Morgan, Senior Manager, Global Logistics, PCI Pharma Services,has worked within the clinical trial industry for 21 years, with a focus on the distribution of clinical materials globally. Located in the United Kingdom, Gavin has been overseeing clinical distribution at PCI since 2009, previously working as the Logistics Manager at Bilcare Global Clinical Services (now Sharp Clinical) between 2000 – 2009. His main responsibilities at PCI include oversight of all activities associated with UK and EU imports and supporting the full supply chain of clinical trial supplies incl. the selection and management of 3rd party couriers and depots.
As a respected industry leader and trusted partner PCI Pharma Services provides a comprehensive range of outsourced pharmaceutical services that stretches all the way from early stage development to long-term commercial supply. This reputation is based on best-in-class technologies, cutting-edge research, an exceptional team of outstanding people and a consistent record of meeting the highest regulatory and quality standards. Equally important is our commitment to an exceptional customer experience and we share our customers’ passion for supplying lifesaving medicines to patients around the world. We’re committed to meeting their evolving needs by leveraging our experience and expertise to develop the best possible solutions to their drug development challenges.
SmartCAE (computer aided engineering) provides simulations tailored to the field of temperature controlled logistics. For more than 15 years the company has provided customers solutions to thermal engineering challenges in the areas of virtual box testing and design, representative temperature profiles, statistical analysis of lane temperatures, and lane risk analysis.
Cold Chain Consultis an independent specialists with over 60 years of combined industry experience, Cold Chain Consult is the missing link in your cold supply chain. With global expertise and reach, Cold Chain Consult brings compliance and operational experience to your organization as quickly as you need it. The company tailors the number of resources to meet specific needs leaving you time to manage your timelines and budgets. Whatever your organization's current challenge is within the Cold Chain industry, Cold Chain Consult will lead, support, and drive you to success. They are proven partners to all segments of the industry: suppliers, carriers/integrators, small-to-medium enterprises, large global enterprises, non-profits and start-ups.
Peli BioThermal Pharmaceutical companies — and other organizations looking to make significant cost and quality improvements in their cold chains — are switching to Pelican BioThermal for single-use and reusable temperature-controlled packaging. Our innovative, patented technologies and consultative services ensure product quality, mitigate excursion rates, reduce packaging costs and drive Total Cost of Ownership (TCO) across your entire supply chain. Our global network of consultative cold chain experts provides our customers with consistent packaging and logistics experiences wherever they do business. While our full line of single-use and reusable packaging solutions — from parcel to pallet shippers — are competitively priced, the real economic value we bring to our customers focuses on TCO.
Specright is the first cloud-based platform for Specification Management. Whether it’s packaging, raw materials, formulas, products, or machines, Specright helps companies manage data to increase speed to market, reduce costs, and better collaborate with suppliers and partners across their supply chain.
For over 25 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. With a membership base of over 1,400 companies, we connect our members to each other so they can collaborate and work stronger and smarter together. We connect organizations to capital investment and purchasing solutions so they can grow faster and work more efficiently. We're their link to advocacy that fights for innovation and we provide an environment where their business and talent can thrive. Biocom California is how the life science industry gets connected.