Featured Insights
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Key Takeaways From PDA Ireland Microbiology Event On Innovation And Technology
4/14/2025
Insights from a PDA Ireland event reveal how innovative technologies like VR and automation are transforming sterile manufacturing, improving efficiency and addressing contamination control strategies.
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How Healthy Is Your TMF? A Check-In Before An Inspection
3/18/2025
Explore how proper oversight of the Trial Master File (TMF) prevents inspection findings. Regular reviews, heatmaps, and risk-based assessments help ensure TMF health, and readiness for regulatory inspections.
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Five Key Trends In CMC
3/18/2025
CMC is evolving with digitalization, sustainability, supply chain resilience, post-merger integration, and personalized medicine.
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Three Key Takeaways: Best Practices In Environmental Monitoring
3/18/2025
An Environmental Monitoring (EM) program ensures microbial and particulate control in sterile manufacturing. A conference in India covered EM design, data interpretation, contamination risks, and regulatory expectations.
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Effective Digital Engagement For Biopharma Companies
3/18/2025
The NASP Podcast explores biopharma digital engagement, emphasizing strategic communication, data analytics, and best practices to enhance healthcare decision-maker engagement across a product’s lifecycle.
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Rising Sun: The Drug Pricing Environment In Japan Is On The Up
3/18/2025
Japan’s recent pharmaceutical pricing reforms present new opportunities for the industry, fostering innovation while aiming to ensure faster access to treatments.
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Early Network Mapping To Guide HTA Literature Reviews
3/18/2025
How do we identify the right evidence efficiently? Early network mapping can help manufacturers balance a focused scope with the need to conduct indirect treatment comparisons.
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How Will Medical Devices Be Affected In The Era Of EU HTA?
3/18/2025
The EU Health Technology Assessment Regulation (HTAR) mandates Joint Clinical Assessments (JCAs) for high-risk medical devices and medicines, guiding manufacturers in clinical study requirements and regulatory compliance.
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Achieving Best Outcomes With TMF Document Processing
3/18/2025
TMF document processing requires a delicate balancing act. Sponsors strive for accuracy and completeness, but timeliness is crucial. How can teams achieve all three? Here are some practical strategies.
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The Important Role Of The Study Owner In Guiding The TMF
3/18/2025
Learn about the critical role that a study owner plays in maintaining Trial Master File (TMF) oversight, ensuring compliance, and driving collaboration across clinical study teams.