Although the full supply chain is valued by life sciences companies, it’s the last mile that matters the most to the customer. With this in mind, we surveyed 150+ pharma logistics leaders to learn more about the key challenges, solutions and trends impacting the last mile of the life sciences supply chain.
This presentation explores the Health Canada Guide-00069 regulations and requirements in Canada and provides detailed examples of compliance and non-compliance regarding:
Tonino Antonetti, M.Sc., Executive Director, Regulatory Affairs & Quality Management -SHE, Roche Diagnostics
Rafik H. Bishara, Ph.D., Technical Advisor & Former Director QKMTS, Eli Lilly and Company (retired)
With the variety of product lines increasing and the regions, companies are shipping to growing. There are a lot of variables to account for when qualifying your shipments. In particular, USA’s vast geography and temperature gradients pose a big challenge for logistics and supply chain professionals. These challenges show direct parallels with the current environment in Brazil. Shipping from South to North Brazil brings about similar roadblocks as shipments to distant US regions. These issues can be mitigated through smart supply chain management, streamlines logistics, and open communication with supply chain partners. What you will learn:
Luiz Barberini, Operations Manager, External Manufacturing Organization Latin America, Bayer Consumer Health
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
One State now requires that a pharmacy shall ensure the integrity of any drug requiring temperature control that is delivered by mail order by enclosing in each package a measurement device to alert consumers that drugs have been exposed to temperatures that could affect their potency and stability. So how has one of the major pharmacy chains decided to meet that requirement?
Alan Kennedy, Founder and Executive Director, PHARMA TEAM-UP
Ahmed ElSheemy, Head of Quality Assurance Middle East & Turkey, Merck Serono Middle East (a subsidiary of Merck KGaA Germany)
Jennifer Antonetti, Sr. Supervisor Global Distribution Packaging & Shipping Qualification, Biogen
Chris Day, Director of Business Development – Leasing Services, Sonoco ThermoSafe
Bayer’s Unique Relationship Model that will Help you Improve Data Exchange, Network Platforms, and Integration.
Ensuring that all products are delivered on time and that no back orders occur, is an essential KPI across supply chain professionals. Bayer is taking the necessary steps to improve data exchangeand supplier network platforms to achieve better integration and create a balance between supplier collaboration, customer collaboration and peer collaboration.
Presentation by Luiz Barberini, Operations Manager, External Manufacturing Organization, Latin America, Bayer Consumer Health
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:
With 253,834 studies located in 200 countries, ensuring smooth and cost-effective global clinical trial supply has become a standard for the pharmaceutical industry. Experts from all regions have answered our survey on the main pain points they face, how they can improve their supply chain and what drives its success. Anat Batsri, Global Clinical Supply Chain Study Lead at OPKO Biologics, had a look at the results and gave us her feedback on what the results showed.
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:
Plus! Commentary by 2018 Cold Chain Global Forum speakers:
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.
The temperature controlled life sciences supply chain landscape has never been riper for disruption. Though the pharmaceutical industry has changed dramatically over the past 30 years, the pharmaceutical supply chain has remained largely unchained. However, with the influx of biologics and personalized medicine, the growing costs of R&D, increased global regulatory pressure and numerous other emerging trends, the pharmaceutical supply chain is only expected to grow in complexity and expense for the foreseeable future. Given all of the challenges ahead, we asked our Cold Chain Spring 2019 speaker faculty what new, innovations and solutions are on the horizon that could help the reinvent the pharmaceutical cold chain industry as we know it. The following is an overview of the top 3 technologies poised to usher in the next era of temperature-controlled life sciences logistics: Artificial Intelligence, Blockchain and Advanced Analytics.
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.