CLINICAL SUPPLY REGULATORY ARTICLES
Who Pays For The Comparator? Insurance Cost-Sharing And The Wall That Got Taller
Insurance cost-sharing could reduce clinical trial comparator expenses, but federal coverage rules and anti-kickback restrictions create significant challenges for sponsors.
CLINICAL SUPPLY REGULATORY VIDEOS
Decentralized clinical trials are made up of a multitude of elements, from in home clinical capabilities, logistics, digital platforms, and technology, to global reach and more. This webinar shares important factors to consider to build your DCT ‘molecule’ successfully.
Gain insights into managing global trial complexity, balancing accelerated timelines with compliance, using advanced technologies to improve efficiency, and leveraging partnerships to support seamless clinical operations.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
CLINICAL SUPPLY REGULATORY RESOURCES
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![electronic-medical-technology-GettyImages-1204743045]( "Benefits Of Electronic Labels: Investigational Medicinal Products")
When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, learn why a label must be on its packaging that provides relevant and important information.
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![Medical-Research-laborratory-GettyImages-1354172439]( "Investigational Medicinal Products: Labeling Changes And Their Implications")
Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.
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![450_300-ai_in_drug_discovery]( "AI-Driven Signal Management: The Future Of Drug Safety")
By combining autonomy with robust governance, agentic AI enables pharmacovigilance teams to move from reactive to proactive safety management, anticipating risks before they materialize.
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![GettyImages-1070902452-planning-tracking-packaging-shipment]( "Enhancing Quality And Efficiency Through Digitized Clinical Secondary Packaging Processes")
Explore how an innovative software platform can be used to create customized, user-friendly applications to digitize clinical secondary packaging processes.
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![iStock-1224887299-box-logistics-package]( "The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective")
Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.
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![2026 start button-GettyImages-2232020388]( "How Life Sciences Leaders Are Preparing For More Curveballs In 2026")
Anticipate regulatory shifts and supply chain hurdles with agile scenario planning. Move beyond fragmented systems to build a resilient, data-driven foundation for a volatile industry landscape.
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![iStock-486571129-supply-chain-logistics-packaging]( "Is Your Clinical Supply Strategy Ready For EU CTR?")
One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging?
