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
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.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
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.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
CLINICAL SUPPLY REGULATORY RESOURCES
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![GettyImages-1474595785 AI]( "Artificial Intelligence Regulation")
To make the best use of artificial intelligence (AI), drug sponsors need to understand where health authorities are drawing the lines.
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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-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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![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-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-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?
