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
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
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.
Explore how organizations can transform from managing dozens of siloed, protocol-specific RTSM implementations to achieving unified, portfolio-level clinical operations.
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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![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-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-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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![GettyImages-1398569507 regulatory]( "5 Ways To Get Ready For IRT Regulatory Inspections")
Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.
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![GettyImages-1346675513 lab materials]( "Cut Through Complexity, Gain Speed, And Get Your Drug To Patients ASAP")
Discover top challenges that emerging biologics face, packaging containment offerings and services that help mitigate risks, and ways to reduce obstacles that slow development.
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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-1293772957-scientist-laboratory-computer-drug-development]( "Five Key Trends In CMC")
CMC is evolving with digitalization, sustainability, supply chain resilience, post-merger integration, and personalized medicine.
