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Real World Evidence |
We are pleased to announce that Elena Valkanova will be taking over as the new Real World Evidence Working Group Lead. Elena began her career in clinical research more than 20 years ago, specialising in statistical programming and data analysis across diverse therapeutic areas. Throughout her career, she has contributed to the design, validation and reporting of regulatory deliverables, ensuring accuracy, reproducibility and compliance with global standards such as CDISC. Her early academic research into algorithmic game theory focused on developing randomised and strategy-improvement algorithms for simple stochastic games – a rare class of combinatorial problems that lie in both NP and co-NP and have no known polynomial-time solutions – providing a strong foundation in probabilistic modelling, computational complexity, and optimisation. Elena now leads collaborative initiatives to develop practical frameworks and implementation guidance for privacy-preserving methods, including differential privacy, federated learning and synthetic data generation. Her leadership centres on building cross-disciplinary resources that integrate statistical programming, machine learning (ML), artificial intelligence (AI) and large language models (LLMs) to enable compliant, scalable and scientifically robust use of real-world data (RWD). |
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SEND Industry Feedback Survey | ||
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The SEND Industry Feedback Survey project within the Nonclinical Topics Working Group have published their 2025 SEND Survey, marking a significant milestone as it enters its 10th consecutive year of providing valuable industry insights. The survey will remain open from 14 November–11 December. All responses will be collected anonymously. The results will be presented at the Nonclinical Advance Event 10–12 February 2026 and subsequently published on the PHUSE Archive.
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QC Workflow Optimisation | ||
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The QC Workflow Optimisation project within the Emerging Trends & Innovation Working Group have published a survey exploring the current state of Quality Control across the industry. This survey aims to capture an industry-wide view of current Quality Control practices, how they may need to evolve, and the potential role of emerging technologies such as AI. Your input will help shape future PHUSE discussions, highlight areas for improvement or standardisation, and guide next steps for the QC Workflow Optimisation project. The survey will remain open from 3 December – 13 January. All responses will be collected anonymously.
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Nonclinical Advance Event – Save the Date |
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The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming 10–12 February 2026. MoreThe Nonclinical Advance Event will explore key themes including New Approach Methodologies For Nonclinical Safety Assessment, Nonclinical Predictive Modelling And Machine Learning & PHUSE Project Contributions And Developments Full agenda and registration details coming soon! |
Real World Data Autumn Event – Save the Date |
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We’re pleased to announce that the Real World Evidence Working Group will be holding its second multi-day virtual event from 30 September–1 October 2026. Stay tuned for more details and registration information coming soon! |
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