CLINICAL SUPPLY REGULATORY ARTICLES
Have We Got Novel Drug Production And Compliance Timelines All Wrong?
Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.
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.
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.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
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.
CLINICAL SUPPLY REGULATORY RESOURCES
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![Women using auto-injector syringe-GettyImages-1184225794]( "Lifecycle Planning For Containment And Delivery Of Biologics Drug Products")
Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development to set yourself up for future success.
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![Gene Therapy GettyImages-1164556175]( "Determining Clinical Manufacturing Readiness For Cell Therapies")
Review lessons that provide insights on how to ensure quality, improve patient access, and reduce the cost of manufacturing to avoid overestimating your product's readiness.
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![audit management]( "Optimizing Direct-To-Patient Supply Management: ClinChoice And 89Bio")
Learn how the CRO ClinChoice and the sponsor 89Bio were conducting a phase II, randomized, double-blind, placebo-controlled study that needed to pivot to a decentralized protocol during the pandemic or face trial disruption.
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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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![GettyImages-1127105013-lab-computer-research-scientist]( "Designing An Optimal APAC Clinical Supply Chain")
Gain the knowledge and skills needed to effectively navigate the complex clinical supply distribution landscape within this important and rapidly growing region.
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![Warehouse Boxes]( "Trade Compliance: Challenges In Global Biopharma Materials Logistics")
Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!
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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Optimized Laboratory Kitting Is Key To Successful Clinical Trials")
Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.
