Expert guidance across pharma, biotech, and medical devices — stay ahead of industry trends and best practices.
Discover why in-house data often falls short of IVDR clinical performance requirements for IVD software and how to choose the right study design.
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Is your AI use inspection-ready? Explore six questions GMP inspectors may ask about AI governance, human oversight, model changes and validation.
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Discover six common HPV assay validation mistakes, from sample selection and cut-off optimisation to population differences and platform changes.
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Moving an FDA-cleared AI diagnostic to Europe? Learn what evidence transfers, what IVDR requires and how a gap assessment can guide CE marking.
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Can one HPV clinical performance study support both IVDR and WHO Prequalification? Learn how to align requirements and avoid duplicate studies.
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Explore the Meijer criteria for HPV assay validation, including clinical sensitivity, specificity, reproducibility and their role in IVDR and WHO PQ.
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Discover six risks of using LLMs in GMP, from hallucinations and inconsistent outputs to data leakage, and how to manage them responsibly.
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Annex 1 implementation does not end with your first CCS. Learn how to keep contamination control risk-based, current and inspection-ready.
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Regulation (EU) 2025/1466 changes EU signal management and EudraVigilance monitoring. Learn what MAHs need to implement and document.
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The new EU Variations Guidelines change classification, grouping, work-sharing and Type IA planning. Learn what this means for variations management.
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AI is not prohibited in GMP environments. Learn how intended use, risk, human oversight and existing quality controls determine compliant AI use.
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Risk class alone does not determine the clinical evidence needed for IVD software. Learn what should actually drive your IVDR evidence strategy.
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Revision 2 of GVP Module III reinforces subcontractor oversight, immediate PSMF availability, risk-based inspection cycles and remote inspection readiness. Here is what MAHs, QPPVs and pharmacovigilance providers need to know.
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Discover why Medical Information and Pharmacovigilance integration is essential for safety reporting, compliance, efficiency and audit readiness.
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