The Cold Chain Global Forum Spring is heading to San Diego, June 10-12. Join us for the event marries the technology and strategy needed to prepare for the future of supply chains while remaining compliant.
Inspirational Keynotes joining us at the event include:
- Scott Mooney, Vice President Distribution Operations, Supply Chain Assurance, McKesson Pharmaceutical
- Kevin Hickman, Senior Manager, Supply Chain Distribution, Gilead Sciences, Inc.
- Javier Gomez-Contreras, Head of Supply Chain Americas, GlaxoSmithKline (GSK)
- Chris J. Anderson, Director, Quality System, Cardinal Health
- Highlights an innovative partnership and solution to provide insulin access to patients in need, through free clinics and charitable pharmacies.
- Objective: Highlight considerations for both Lilly and Dispensary of Hope
Suzette Figueroa Diaz, Director Access & Affordability, Lilly Diabetes
Steve Stapleton, Director Patient Assistance Programs, Lilly USA & President Lilly Cares Foundation
Scott Cornwell, Chief Supply Chain Officer, Dispensary of Hope Eli Lilly and Company & Dispensary of Hope’s Partnership for Insulin Access
No country is immune to the problems associated with counterfeit medicines. Across the planet, governments are enforcing new regulations and directives to counter the threat of illegal pharmaceuticals to public health and safety.
In this report, ACG examines the EU’s Falsified Medicines Directive – due to be rolled out on February 9 next year.
This paper outlines the insights ACG have gained from their experience in Track & Trace implementation, highlights the challenges faced by pharmaceutical companies across the EU, and posits potential methods of overcoming them. With awareness of counterfeiting increasing, the pharmaceutical industry should be agile in the coming months, and learn to consider regulations as obligations in the years to come.
This whitepaper covers:
- IoT and blockchain will enable proactive shipment management. No longer will practitioners be restricted to post-shipment for analysis and excursion management, increasing the sector's ability to mitigate risk to the product and the patient.
- The future of the sector will be characterised by solutions that are software driven rather than hardware driven. The benefit of this is that logistics services and shippers will no longer be tied down to a single device, or group of devices that have restricted connectivity.
- A device-agnostic software system that can switch to the latest technology, which will put the shipper in a much more flexible position in terms of their purchasing ability. It will also ensure that the sector can maintain fluidity and adapt to newer technologies far easier than ever before.
A look into the concept of global standardization with risk management in the cold chain.
This whitepaper explores supply chain security and validation as they pertain to lane qualification, data monitoring, shipping lanes and stability budgets.
This whitepapers covers the latest pharmaceutical logistics regulatory developments around the globe related to FMD, MHRA, ICH Q12, PACMP, GMP, DSCSA and more! Designed specifically to keep you up to date with key developments that we believe with shape the compliance agenda over the next year, key developments that you will need to tune in for! Highlights include:
- GMP inspections international collaboration efforts
- Supply Chain Security and Traceability – GPS
- EMA regulations
- Points to remember for your next GDP inspection
- The latest on Human Drug Compounding Outsourcing Facilities regulations
- An analysis of ICH Q12 concepts
- The cost of Brexit and the road forward
- An overview of EU's recently published report detailing the implementation of the Falsified Medicines Directive (FMD)
Plus! Commentary by 2018 Cold Chain Global Forum speakers:
- Rafik Bishara, Ph.D, former Director QKMTS, Eli Lilly and Company
- Ajay Pazhayattil, Former Associate Director, TOPV Apotex Inc.
Top Challenges & Solutions for Protecting Ambient and Room Temperature Products
Not too long ago, “ambient,” “room temperature” and even “controlled room temperature” (CRT) were considered synonymous and, as they were considered more or less resilient again temperature excursions, were provided little to no thermal protection across the supply chain. However, this is beginning to change. Increased regulatory focus, an improved understanding of how inappropriate storage conditions impact product integrity and the increased volume of temperature sensitive CRT biosimilars/biologics have pushed manufacturers to pay just as much attention to room temperature products as they do traditional cold chain drugs.
This being said, transporting room temperature drugs is not without its challenges. Though it may sound counterintuitive, safeguarding room products from temperature excursions can actually be more expensive and difficult than protecting their cooler counterparts. From reasons raging from costs to simple effectiveness, one simply just can’t apply the same solutions and methodologies to ambient products as they do those that require refrigeration.
With this in mind, below we’ve outlined the key challenges and solutions associated with protecting CRT and ambient drugs across the supply chain.
Though still in its infancy, the global precision medicine market already accounted for roughly $43.59 billion in 2016 and is estimated to reach $141.70 billion by 2026, according to a 2017 market intelligence report by BIS Research, titled "Global Precision Medicine Market- Analysis and Forecast, 2017-2026." Furthermore, in 2017, the FDA broke a record for the most new drug approvals, the majority of which were for personalized medicines.
But what does this mean for cold chain leaders? We asked the 2019 Cold Chain Spring speaker faculty about the challenges and innovative opportunities associated with the personalized medicine supply chain. Highlights include:
- How the emergence of precision medicine will change the pharma supply chain
- How industry leaders are embracing digitization and serialization tools to tackle many of the supply chain challenges associated with specialty medicine such as increased complexity and high costs
- How to partner with external partners to ensure they're fully prepared for the age of personalized medicine
- Why robust planning, end-to-end visibility and collaboration are essential for optimizing the personalized medicine supply chain
Get a sneak peek of who you can expect to meet and learn from at Cold Chain Spring!
Warehouse management systems (WMS) are all too often unable to comply with serialization requirements or deliver mandated reports due to their complexity and high degree of customization. In order to ensure compliance to DSCSA and FMD standards as well as more effectively control costs, companies need to invest in smarter inventory tracking and more efficient warehousing operations.
In this article, Larry Hall of Tracelink discusses how pharmaceutical serialization requirements are driving demand for smarter inventory tracking and warehouse management. In addition, Hall also provides use cases to highlight key considerations for ensuring life sciences warehousing operations are compliant.