CLINICAL SUPPLY REGULATORY ARTICLES
Vendor/Supplier Management To Maintain A Drug's Safety Profile In End-To-End Supply Chain Planning
FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.
CLINICAL SUPPLY REGULATORY VIDEOS
Choosing the right clinical packaging and supply chain partner to support APAC studies can vary significantly based upon which countries are involved and the types of services required.
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.
Understand how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.
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.
CLINICAL SUPPLY REGULATORY RESOURCES
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![GettyImages-836663414 medical team meeting]( "Sponsor Overcomes Hold And Steers Products Through Development")
Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.
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![GettyImages-1070902452-planning-tracking-packaging-shipment]( "Enhancing Quality And Efficiency Through Digitized Clinical Secondary Packaging Processes")
Explore how an innovative software platform can be used to create customized, user-friendly applications to digitize clinical secondary packaging processes.
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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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![GettyImages-1327568875-technology-clinical trials-computer-medicine-research]( "A Smart Solution To Clinical Supply Management")
Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.
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![iStock-1214764688-scientist-lab-analyze-research]( "Global Clinical Supply Solutions For Every Trial")
A reliable clinical supply chain strategy is as essential as a company’s discovery program. Seek a partner who can help guide a comprehensive strategy and manage day-to-day activities.
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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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![Scientist research laboratory pipette GettyImages-487041629]( "Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions")
Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.
