Regulatory Insights
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Realizing Business Benefit And Inspection Readiness With A Solid CAPA Framework
5/8/2024
Embracing proactive quality culture transforms CAPA from a routine task to a continuous improvement tool. Learn how senior management support and robust processes drive excellence.
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Getting The CAPA Framework Right The First Time
5/8/2024
CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.
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How Project Optimus Is Influencing Emerging Biopharma And Biotech
5/7/2024
With expertise in the evolving clinical trial landscape and solutions tailored to individual needs, discover how navigating the challenges of oncology drug development is manageable.
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A Clearer Harmony And Attractiveness For EU Clinical Trials Regulation
5/6/2024
Explore the latest insights on navigating the transition to the EU Clinical Trials Regulation (EU CTR) and ensuring alignment across stakeholders for seamless adaptation in this Pharmaphorum podcast.
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Optimizing CAGT Post-Trial Long-Term Follow-Up
5/6/2024
Uncover how navigating longer study durations presents unique challenges, necessitating efficient data collection methods and flexibility to adapt to evolving patient journeys and regulatory landscapes.
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Shifting The Approach: 4 Strategies For ICH E6(R3) Implementation
4/30/2024
In addition to codifying some best practices, R3 suggests sponsors take a proportionate approach to identifying and managing areas of risk.
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6 Decades Of Impact: DIA’s Global Journey
4/29/2024
By embracing its foundational pillars, learn how DIA continues to address ongoing challenges in drug information and healthcare as it enters its seventh decade in the industry.
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Key Transition Timelines For Clinical Trials Regulation (CTR)
4/29/2024
As deadlines loom for transitioning ongoing clinical trials in the EU to the Clinical Trials Regulation (CTR), understanding key timelines and dates becomes critical.
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The Synergistic Role Of Drug Safety In Clinical Trial Operations
4/25/2024
Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.
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Considerations For Plain Language Summaries
4/22/2024
Recent FDA emphasis on plain language underscores a shift towards greater transparency and patient understanding, highlighted in the joint FDA and Office for Human Research Protections (OHRP) draft guidance.