CLINICAL SUPPLY REGULATORY ARTICLES
New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability
A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.
CLINICAL SUPPLY REGULATORY VIDEOS
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.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
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.
CLINICAL SUPPLY REGULATORY RESOURCES
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![GettyImages-1413600685-lab-team-collaboration-computer-research]( "Reaching First-In-Human Trials Faster: Connect With The Right Partner")
Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.
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![GettyImages-2162599103-tablet-pen-graphs-data]( "Analytics–Powered Approach To Patient Recruitment Strategy")
In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.
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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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![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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![Vaccine injectable vials and syringe GettyImages-1252804942]( "Developing Injectable Drug Placebo Formulations For Clinical Trials")
Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.
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![GettyImages-1078167682-brexit-uk-ireland-eu]( "Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain")
With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.
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![iStock-1293772969-lab-microscope-scientist-research]( "Clinical Manufacturing: What It Is And How It Works")
Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?
