CLINICAL SUPPLY REGULATORY ARTICLES
New Initiative Seeks To Back Up ICH's Harmonization Mission
An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.
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.
In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes.
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-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?
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![GettyImages-1214112149-lab-team-collaboration-research]( "Creating Accurate, Efficient, And Effective CDMO Project Proposals")
To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.
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![iStock-1088247762-risk]( "Avoiding The Risk Of A Non-Transparent Clinical Supply Solution")
With the supply chain and transportation logistics disruption caused by the COVID-19 pandemic, full documentation and complete transparency becomes even more important to avoid delays and assert provenance.
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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-1294339697-computer-monitor-test-research-controls]( "Master Protocol Studies: Technology Considerations For The 'Never Ending' Clinical Trial")
Since the FDA is now encouraging creativity in trial designs, it is important for all stakeholders to adapt processes to follow the science and ultimately bring medicines to patients, faster. This white paper addresses the complexities that come with these trial designs, and how randomization and trial supply management (RTSM) solutions are critical to run flexible, robust, and quality-driven trials.
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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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![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.
