This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?
- Key Considerations For Early-Stage CGT Companies When Selecting A CDMO
- Survey Findings: How Are IDMP Readiness Efforts Progressing?
- AstraZeneca's Digitally Connected Strategy For API Manufacturing
- The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond
- Solving The Leukopak Supply Chain Issue With Cryopreservation
- Is The BIOSECURE Act The First Real Step Toward Reshoring?
- Defining When To Implement Technologies To Support Commercial Growth
- Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
ON-DEMAND WEBINARS
The complexities of sample collection and logistics in advanced therapy studies naturally brings chain of custody challenges in protecting the integrity of a trials’ high value samples. Learn about end to end sample management strategies, logistical integration planning, real-time tracking and LIVE monitoring technologies.
Learn more about new glass vial options that combine performance and sustainability to help pave the way to a greener future.
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.
This webinar will offer best practices for UAT for sponsor organizations with the aim of changing the conversations and expectations around the UAT process.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-486571129-supply-chain-logistics-packaging]( "Is Your Clinical Supply Strategy Ready For EU CTR?")
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-2036497698 clinical lab]( "Solutions For Sponsors Utilizing Drafted Guidance For PROs In Oncology")
Solutions For Sponsors Utilizing Drafted Guidance For PROs In OncologyExplore the challenges pharmaceutical companies face in implementing PROs in cancer clinical trials as outlined in the FDA’s draft guidance, as well as strategies to overcome these obstacles.
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![Doctor Preparing Injection Site GettyImages-1379313214]( "A Practical Packaging Components Checklist For Emerging Biotechs")
A Practical Packaging Components Checklist For Emerging BiotechsA proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.
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![Doctor Patient Engagement]( "Distributing Clinical Supply In The EU For Compassionate Use Programs")
Distributing Clinical Supply In The EU For Compassionate Use ProgramsExplore the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program, especially when faced with COVID-19 closures and challenges.
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![GettyImages-1346675584-team-lab-research-development]( "Key Considerations For Emerging Companies When Selecting Packaging Components")
Key Considerations For Emerging Companies When Selecting Packaging ComponentsRecognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
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![Sperm-bank-GettyImages-1333952315]( "Cryobag Container Development For Cell & Gene Therapies")
Cryobag Container Development For Cell & Gene TherapiesISR Reports addresses the logistical challenges faced by developers of cell and gene therapies regarding cold chain and cryopreservation.
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![GettyImages-1173740564 data management]( "Navigating Audit Trail Data Regulations And Accessibility Changes")
Navigating Audit Trail Data Regulations And Accessibility ChangesData is the single most important thing in a clinical trial. Leverage the power of clinical trial data with effective utilization and access in a changing regulatory landscape.
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![GettyImages-1163506017 labeling]( "IMP Labeling: EU CTR Transition Considerations")
IMP Labeling: EU CTR Transition ConsiderationsReview current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.
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![GettyImages-980809416 clinical supply]( "Common RTSM/IRT AN Medication Pooling Questions Answered")
Common RTSM/IRT AN Medication Pooling Questions AnsweredWhether you’re planning a single trial or an entire program, medication pooling offers a pathway to cost-effective and sustainable clinical trial management.
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![Panademic Related Manufacturing Complications]( "Outsourcers Are Feeling Uneasy About Continuity Of Supply")
Outsourcers Are Feeling Uneasy About Continuity Of SupplyFind out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.
CATALENT CORNER
| Insights from Catalent's Clinical Supply Experts |
SPONSORED CONTENT
Impact Of Supplier Choice On APAC Clinical Trial Execution
Learn about strategies Asia-Pacific has become an increasingly complex and congested destination for clinical trials as local and global sponsors alike flock to the region to take advantage of its many benefits, including access to large patient pools. Choosing the right clinical packaging and supply chain partner to support these studies is critical and can vary significantly based upon what countries are involved and the types of services required.
