Expert guidance across pharma, biotech, and medical devices — stay ahead of industry trends and best practices.
Learn how to manage CAPA backlogs through risk-based triage, root cause analysis and effectiveness checks to strengthen GMP inspection readiness.
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Learn how to use grouping and worksharing under the 2025 EU Variations Guidelines to coordinate submissions and improve lifecycle planning.
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Explore three ways to integrate EudraVigilance data into signal management, from validation and evaluation to risk-based detection and monitoring.
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Your app qualifies as a medical device. Learn what EU MDR means for clinical evidence, Agile development, ISO 13485, CE marking and ongoing compliance.
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When does a wellness app become a medical device under the EU MDR? Explore intended purpose, software qualification, Rule 11 and common grey areas.
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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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