Regulatory Insights
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Accelerate Respiratory Disease Trials: A Guide To Digital Endpoints
4/15/2025
Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
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Unlocking Continued Revenue And Growth From Established Products
4/14/2025
Gain insights into how pharmaceutical companies successfully handle post-approval regulatory upkeep for established products, focusing on reducing operational costs and expanding global market access.
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Exploring Payer Coverage Of Anti-Obesity Medications
4/14/2025
Understanding payer strategies for anti-obesity drugs is crucial. A recent study investigated commercial formulary trends, confirming cost as a major barrier despite positive patient outcomes.
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5 Questions On Exploring Healthcare Decision-Maker Sentiments
4/14/2025
Research presented at AMCP 2025 uses natural language processing on decision-maker feedback to predict coverage. Learn about the surprising findings and next steps in this Q&A.
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Scientific Literature Reviews And AI's Potential For Evidence Synthesis
4/14/2025
Scientific literature reviews are crucial for HEOR decision-making but notoriously slow. Explore how AI can potentially accelerate evidence synthesis while maintaining necessary scientific rigor.
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Key Takeaways From The ISPE Aseptic Processing Seminar
4/14/2025
How is the pharmaceutical industry increasing aseptic processing safety? An ISPE event showcased innovations like robotics and improved risk management, aligning with recent regulatory guidance.
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Essential Guide To Post-Approval Regulatory Lifecycle Maintenance
4/14/2025
Learn about the growing trend of regulatory affairs outsourcing in pharma, driven by R&D growth and the need for specialized expertise to manage product lifecycles effectively.
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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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Navigating The 7 Biggest Challenges In Rare Disease Clinical Trials
4/11/2025
Discover how partnering with specialized rare disease CROs allows drug sponsors to accelerate treatment development, navigate trial complexities, and ultimately improve patient outcomes.
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Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia
4/11/2025
Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.