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Navigating Breaks in the Supply Chain and Managing Import Requirements

When:

September 14, 2021 10:00 am – September 14, 2021 11:00 am PDT

Where:

WEBINAR

Online, Zoom

Registration Closed


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.

Featured Speakers:

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Christine Wenner, Sr. Clinical Supply Chain Manager, PCI Pharma Services

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/Cold Chain/IVRS, process mapping, change management, quality systems, and label design and randomization generation.


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Gavin Morgan, Senior Manager, Global Logistics, PCI Pharma Services

Gavin 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 including the selection and management of 3rd party couriers and depots.


Resources:

Guide to Temperature Monitoring

ELPRO Case Study – Lundbeck Monitoring

ELPRO New Approach to Clinical Study

ELPRO IoT and Real Time Monitoring


Co-Host Sponsor: ELPRO

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ELPRO has been a partner to biopharma companies for three decades developing compliant data monitoring systems for facilities and products in-transit. ELPRO’s data loggers and software protect your biotech assets from lab to supply chain: growing and adapting as your products move through trials and into market. ECOLOG Monitoring Solutions for Rooms and Equipment allows great flexibility to access your facility remotely via internet browser to see temperature, CO2, RH, Pressure differential or any 4-20mA signal. LIBERO PDF multi-alarm data loggers monitor shipments to control a wide-range of biotech applications (-200C…+200C) including clinical trial kits, ultra-low shipments and APIs. Ask us about new developments in real-time monitoring and wireless monitoring. ELPRO’s US headquarters is in Marietta, Ohio since 2003 with a full technical support staff; and offices in San Diego and San Francisco.


Presenting Sponsor: PCI Pharma Services

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As a respected industry leader and trusted partner we provide 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.


Supporting Sponsor: Pelican BioThermal

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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.


Supporting Sponsor: Cold Chain Consult

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Independent Specialists in their area, with over 60 years combined industry experience, Cold Chain Consult is that missing link in your cold supply chain. Our global expertise and reach can bring the compliance and operational experience and expertise to your organization as quickly as you need it. We will tailor the number of resources to your specific need, so that you can manage your timelines and budgets. Whatever your organization's current challenge is within the Cold Chain Industry, we will lead, support, and drive you to success. We are proven partners to all segments of the industry – to suppliers, carriers/integrators, to small-to-medium enterprises, large global enterprises and to the non-profits and start-ups.


Supporting Sponsor: SmartCAE

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SmartCAE (CAE = Computer Aided Engineering) is a small team of highly qualified, motivated and enthusiastic engineers and physicists. We provide software solutions for engineering tasks mainly in but not restricted to the area of thermal engineering for more than 15 years and customers in a wide range of branches. The "Smart" in our company’s name we want to be understood as opposite to "Brute Force": We are convinced that it is not always the most involved mathematical model and the highest computing capacities that lead to the best results. Furthermore we believe that "CAE" should not produce colorful pictures but useful answers. Our focus thus is on software that is easy to use and computation models that are appropriate to the given tasks. Our demand is to always deliver maximal possible benefit for minimal possible expenses.



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