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The Data Transparency Working Group is preparing for its upcoming multi‑day virtual event, taking place 15–17 September 2026 at 10:00–12:30 (EDT) / 15:00–17:30 (BST) / 16:00–18:30 (CEST). The event will focus on the evolving landscape of clinical data transparency, including approaches to data sharing, anonymisation, governance and enabling responsible access to clinical data.
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Real World Data Autumn Event – Save the Date | ||
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The Real World Evidence Working Group is preparing for its upcoming multi‑day virtual event, taking place 30 September–1 October 2026 at 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST). Join the PHUSE Community to explore the evolving landscape of real-world data (RWD), including its growing role in clinical research and regulatory decision-making. This event will bring together global experts to share insights, practical approaches, and real-world applications of RWD.
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Risk Based Quality Management |
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The Enhanced Risk-Based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials Project within the Risk Based Quality Management Working Group has published a new White Paper. This paper provides practical recommendations for applying risk‑based quality management (RBQM) in small and early‑phase clinical trials, covering quality‑by‑design principles, risk assessment using critical‑to‑quality factors, targeted monitoring strategies, and approaches to overcome adoption challenges, while ensuring participant safety and regulatory compliance. |
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The SEND Industry Feedback Survey project, under the Nonclinical Topics Working Group, is looking for volunteers to support this exciting initiative. This project will help gather valuable industry insights and feedback to support future discussions and improvements within the SEND space. If you are interested in contributing, collaborating with peers, and helping shape this project, we’d love to hear from you. Find out more information about the project on the Volunteer Board. To get involved, please complete the New Member Onboarding Form.
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