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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). |
Working Group Q3 Q4 Reports |
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The Working Groups quarterly report is now live! This report showcases the incredible These reports highlight the fantastic progress across our projects, spotlighting featuring key achievements and the exciting work still underway. Dive into the full report to explore Explore the complete reports to see how each project is driving innovation and impact and innovation. Plus, check out a detailed breakdown of the events that have shaped this quarter’s journeyRevisit the events from this quarter and explore what’s coming up next. |
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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 to 3 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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