CLINICAL SUPPLY REGULATORY ARTICLES
EU Reg. 536/2014's Expiry Label Requirement Forces Us Backward, Not Forward
In a world shifting toward advanced technology, the new EU Regulation No. 536/2014's Annex VI is forcing us back into the paper age; specifically, the new requirement to print the expiry date on the primary container label, not just the external carton label. This article describes what is now required, how we got here, and how we can move the industry forward.
CLINICAL SUPPLY REGULATORY VIDEOS
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
This webinar aims to introduce the main regulatory themes, as well as provide a practical insight into converting regulatory theory to practical steps to enable DtP on global studies.
Achieving supply chain resilience is crucial, and flexible distribution strategies and ready-to-use depot and logistics networks are instrumental in establishing limitless flexibility and expertise capable of identifying possible risks.
CLINICAL SUPPLY REGULATORY RESOURCES
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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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![Cells]( "The RMAT Designation: What It Means To The Advanced Therapy Supply Chain")
The RMAT designation gives the sponsor of a new drug access to increased meeting opportunities with FDA, in a manner comparable to those offered to sponsors of breakthrough-designated therapies. In fact the RMAT may be considered as analogous to the breakthrough designation for regenerative medicine drugs.
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![iStock-136140244-lab-pharma-equipment-process]( "Speed To Market – API Large-Scale Commercial Manufacturing")
Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.
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![GettyImages-1127958533 regulations]( "Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change")
A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.
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![iStock-1209968955]( "Decentralized Clinical Trials: A Win For Patients, Sponsors, & Investigators")
Learn how the integral role of Direct-to-Patient Services plays a part in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.
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![GettyImages-1163506017 labeling]( "IQVIA Labeling Compliance Solutions")
Learn how by having a strategy for “core-to-carton” compliance, drug developers can avoid risks for patients and their company.
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![iStock-1288879010-gloves-mask-box]( "5 Common Clinical Supply Chain Speedbumps")
Clinical trials can be very complex. Discover the need to connect planning and oversight from sourcing to shipping, along with mastering requirements such as cold chain, border slowdowns, and data privacy.
