Are you prepared for the FDA’s phase out of animal tests for mAbs?
2025 年 4 月 30 日 - 11am ET
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How Certara MIDD Experts Overcame Client Regulatory Challenges
Certara’s Model-Informed Drug Development (MIDD) approach leverages an integrated, quantitative systems methodology to accelerate regulatory…
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Standardizing Real World Data in Rare Disease: ATHN’s Journey
The American Thrombosis and Hemostasis Network (ATHN), a not-for-profit organization, has been improving care and…
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Streamline Clinical Data Publication Under EMA Policy 0070
2025 年 2 月 14 日 The European Medicines Agency (EMA) Policy 0070 requires clinical data publication. Its…
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Simcyp Version 24: Advancing PBPK capabilities and translating new science and technology into regulatory-accepted predictive modeling
With the release of Version 24, the Simcyp Simulator introduces cutting-edge enhancements that further elevate…
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How to Validate Your Clinical Data Using FDA Validation Rules
2025 年 1 月 30 日 For clinical data managers, understanding clinical data validation and applying FDA validation…
Danielle Pillsbury2025 年 1 月 30 日
