CLINICAL SUPPLY REGULATORY ARTICLES
Quick Takes From Takeda Austria’s Annex 1 Rollout
At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.
CLINICAL SUPPLY REGULATORY VIDEOS
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Clinical supply innovators from across the industry share their experiences and lessons learned as they work to normalize the use of adherence measurement tools and smart medicine packages.
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.
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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![Ampoule Aseptic Filling GettyImages-1490244818]( "Advantages Of Robotic Aseptic Processing")
Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.
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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-136640925-vial-vaccine]( "Leveraging The Bolar Exemption To Accelerate Market Access")
Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.
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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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![GettyImages-1189150676-Medicinal_Marijuana_Cannabis_ControlledSubstance]( "Controlled Substances In Clinical Trials")
Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
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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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![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.
