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Data Transparency Autumn Event 2025 |
Active since 2014, PHUSE’s Data Transparency Working Group has provided subject matter expertise for the review of draft deliverables and guidance documents from regulatory bodies (such as the EMA and Health Canada), as well as other industry organisations (such as TransCelerate) and academia. Since their inception in 2020, the free-to-attend Data Transparency Events have gone from strength to strength. These virtual events have created an unrestricted space where questions can be asked and challenges addressed. Individuals passionate about the area can come together to share vital knowledge, develop new ideas and spark innovation through presentations, panel discussions and Q&A sessions alongside experts in the data-sharing field. The PHUSE Data Transparency Autumn Event will take place on 16-18 September 2025. Data Transparency Events offer you the chance to gain knowledge and experience from a wide data transparency community, allowing you to come together with experts from a variety of companies and backgrounds. Registration for this event will open in July. |
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The Analyses & Displays for Hepatotoxicity project within the Safety Analytics Working Group, have published a new White Paper! This White Paper provides recommendations for displaying, summarising and analysing measures of hepatotoxicity in tables, figures and listings (TFLs). The suggested TFLs will have implications for what and how liverrelated data should be collected. If the data required to populate these TFLs is not collected, then there may be insufficient information to adequately assess the potential for a drug to cause or contribute to the cause of hepatotoxicity. |
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A new Data Transparency deliverable is out for public review! The Rare Disease/Small Population Data Sharing project has produced a new White Paper - “Rare Disease Clinical Data Sharing” and are seeking your feedback. The purpose of this White Paper is to review potential barriers to the sharing of rare disease data such as risk of re-identification and invasion of privacy (balanced against maintaining data utility) and understand if, and how, these barriers apply to controlled access data sharing under specific contextual assumptions. The development of strategies to enable rare disease data to be shared effectively and be reused is needed to advance research and clinical trial design where there is significant unmet need. Email workinggroups@phuse.global by 7April to contribute your feedback! |
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